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Two former board chairs of the Coalition for Healthcare Communication (CHC) were named as the Medical Advertising Hall of Fame (MAHF) 2025 inductees – Sharon Callahan, former Chief Client Officer at Omnicom Health Group (OHG), and Nick Colucci, former Chairman and CEO of Publicis Health/COO of Publicis Groupe North America. The inductees will be honored […]

It is often said that medicine is both an art and a science. In an imperfect world this is both inevitable and desirable. But it is extremely important that the two should not be confused with each other. In particular, because the “science” side of the equation has achieved overwhelming prestige and authority, it is...

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<p>On 3^&nbsp;June 2024,&nbsp;Resolution&nbsp;RDC No. 876 was published in Brazil in the Official Journal of the Union (DOU)[1],&nbsp;modifying the current regulations regarding the post-registration of biological products (RDC 413/2020).</p>

<p> <b>23rd Regulatory Affairs Conference 202</b><b>5</b><br /> <b>27</b><b>‒</b><b>28 February 2025</b><br /> Hilton Amsterdam Airport Schiphol<br />Amsterdam, The Netherlands</p>

<p>In May 2024, Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) announced that it will trial new timelines for variation applications&nbsp;of registered pharmaceutical products and natural health supplements (TMHS).</p>

<p>The European Commission (EC) granted marketing authorization for<b>&nbsp;</b>three ustekinumab biosimilars<b>:&nbsp;</b>Samsung Bioepis’ Eksunbi on 12 September 2024; Formycon’s Fymskina, and Fresenius Kabi’s&nbsp;Otulfi on 25 September 2024.</p>

<p> <b>Abstract</b><br />CinnaGen, the largest biopharmaceutical company in the MENA region, is a leader in developing follow-on biologicals/biosimilars. Dr&nbsp;Haleh Hamedifar, Chairperson of CinnaGen, spoke to GaBI<i>&nbsp;</i>(Generics and Biosimilars Initiative) about the company’s strategic focus, which includes expanding its product portfolio, entering highly regulated global markets, and advancing affordable treatments for conditions such as multiple sclerosis and&nbsp;immunological diseases—transforming healthcare in underserved regions.</p><p><b>Keywords</b>: Biosimilars, clinical development, commercialization, MENA</p>

The Royal Pharmaceutical Society and the British Pharmaceutical Students’ Association have called for all overseas candidates to sit the March 2021 registration assessment in their home countries.

The type 2 diabetes mellitus drug semaglutide is effective for weight loss in non-diabetic overweight or obese adults, when taken alongside a reduced-calorie diet and exercise, researchers have found.

Community pharmacies able to administer up to 400 COVID-19 vaccines per week can now apply to become designated vaccination sites, NHS England has said.

By Haojing Rong and Aimee Raleigh, as part of the From The Trenches feature of LifeSciVC This blog post is the second in a series on key diligence concepts and questions. If you missed the intro blog post yesterday, click

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Novartis recently announced the acquisition of Mariana Oncology, an emerging biotech focused on advancing a radioligand therapeutics platform, for up to $1.75 billion in upfronts and future milestones. The capstone of its three short years of operations, this acquisition represents

The post Mariana Oncology’s Radiopharm Platform Acquired By Novartis appeared first on LifeSciVC.

By Ankit Mahadevia, former CEO of Spero Therapeutics, as part of the From The Trenches feature of LifeSciVC Drug development is complex. So is running a business. Sometimes, the work of doing both can make your head spin. In my

The post Boiling It Down: Conveying Complexity For Decision-makers appeared first on LifeSciVC.

Having just turned 50, I’ve been reflecting on my first half-century of late… many fun and impactful moments, a few regrets, and a life I’ve tried to live to the fullest. One thread that has run throughout it has been

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By Mike Cloonan, Chief Executive Officer of Sionna Therapeutics, as part of the From The Trenches feature of LifeSciVC The drug development process in rare diseases is rife with challenges especially when companies target significant differentiation or first-in-class targets. Identifying

The post Looking for Opportunities to Accelerate Clinical Research in Rare Diseases appeared first on LifeSciVC.

By Ankit Mahadevia, chairman of Spero Therapeutics, as part of the From The Trenches feature of LifeSciVC A common theme in startup literature is that by cutting a range of unnecessary tasks, a step-change in results will follow.  I’ve found

The post Keeping It Simple: What Really Matters For Emerging Enterprises   appeared first on LifeSciVC.

Today’s market likes products. Platforms aren’t in vogue anymore. Investors, especially in the public markets, only want late stage de-risked assets. Pharma only seems to be buying these kinds of asset. VCs need to focus on clinical stage companies. Or

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Your daily light exposure impacts your health. A new study finds that too much light at night and not enough natural light during the day can be harmful. This story first aired on Morning Edition on Nov. 4, 2024.

A person has tested positive in British Columbia, Canadian health officials said, though the results must be sent to another lab for confirmation.

President-elect Donald Trump tried unsuccessfully to get rid of the Affordable Care Act during his first term. What action will he take this time around?

Participant reported relief from chronic low back pain and reduced need for pain-relief medications.

Elemind, a 5-year-old startup based in Cambridge, Mass., today unveiled a US $349 wearable for neuromodulation, the company’s first product. According to cofounder and CEO Meredith Perry, the technology tracks the oscillation of brain waves using electroencephalography (EEG) sensors that detect the electrical activity of the brain and then influence those oscillations using bursts of sound delivered via bone conduction.

Elemind’s first application for this wearable aims to suppress alpha waves to help induce sleep. There are other wearables on the market that monitor brain waves and, through biofeedback, encourage users to actively modify their alpha patterns. Elemind’s headband appears to be the first device to use sound to directly influence the brain waves of a passive user.

In a clinical trial, says Perry [no relation to author], 76 percent of subjects fell asleep more quickly. Those who did see a difference averaged 48 percent less time to progress from awake to asleep. The results were similar to those of comparable trials of pharmaceutical sleep aids, Perry indicated.

“For me,” Perry said, “it cuts through my rumination, quiets my thinking. It’s like noise cancellation for the brain.”

I briefly tested Elemind’s headband in May. I found it comfortable, with a thick cushioned band that sits across the forehead connected to a stretchy elastic loop to keep it in place. In the band are multiple EEG electrodes, a processor, a three-axis accelerometer, a rechargeable lithium-polymer battery, and custom electronics that gather the brain’s electrical signals, estimate their phase, and generate pink noise through a bone-conduction speaker. The whole thing weighs about 60 grams—about as much as a small kiwi fruit.

My test conditions were far from optimal for sleep: early afternoon, a fairly bright conference room, a beanbag chair as bed, and a vent blowing. And my test lasted just 4 minutes. I can say that I didn’t find the little bursts of pink noise (white noise without the higher frequencies) unpleasant. And since I often wear an eye mask, feeling fabric on my face wasn’t disturbing. It wasn’t the time or place to try for sound sleep, but I—and the others in the room—noted that after 2 minutes I was yawning like crazy.

How Elemind tweaks brain waves

What was going on in my brain? Briefly, different brain states are associated with different frequencies of waves. Someone who is relaxed with eyes closed but not asleep produces alpha waves at around 10 hertz. As they drift off to sleep, the alpha waves are supplanted by theta waves, at around 5 Hz. Eventually, the delta waves of deep sleep show up at around 1 Hz.

Ryan Neely, Elemind’s vice president of science and research, explains: “As soon as you put the headband on,” he says, “the EEG system starts running. It uses straightforward signal processing with bandpass filtering to isolate the activity in the 8- to 12-Hz frequency range—the alpha band.”

“Then,” Neely continues, “our algorithm looks at the filtered signal to identify the phase of each oscillation and determines when to generate bursts of pink noise.”

To help a user fall asleep more quickly [top], bursts of pink noise are timed to generate a brain response that is out of phase with alpha waves and so suppresses them. To enhance deep sleep [bottom], the pink noise is timed to generate a brain response that is in phase with delta waves.Source: Elemind

These auditory stimuli, he explains, create ripples in the waves coming from the brain. Elemind’s system tries to align these ripples with a particular phase in the wave. Because there is a gap between the stimulus and the evoked response, Elemind tested its system on 21 people and calculated the average delay, taking that into account when determining when to trigger a sound.

To induce sleep, Elemind’s headband targets the trough in the alpha wave, the point at which the brain is most excitable, Neely says.

“You can think of the alpha rhythm as a gate for communication between different areas of the brain,” he says. “By interfering with that communication, that coordination between different brain areas, you can disrupt patterns, like the ruminations that keep you awake.”

With these alpha waves suppressed, Neely says, the slower oscillations, like the theta waves of light sleep, take over.

Elemind doesn’t plan to stop there. The company plans to add an algorithm that addresses delta waves, the low-frequency 0.5- to 2-Hz waves characteristic of deep sleep. Here, Elemind’s technology will attempt to amplify this pattern with the intent of improving sleep quality.

Is this safe? Yes, Neely says, because auditory stimulation is self-limiting. “Your brain waves have a natural space they can occupy,” he explains, “and this stimulation just moved it within that natural space, unlike deep-brain stimulation, which can move the brain activity outside natural parameters.”

Going beyond sleep to sedation, memory, and mental health

Applications may eventually go beyond inducing and enhancing sleep. Researchers at the University of Washington and McGill University have completed a clinical study to determine if Elemind’s technology can be used to increase the pain threshold of subjects undergoing sedation. The results are being prepared for peer review.

Elemind is also working with a team involving researchers at McGill and the Leuven Brain Institute to determine if the technology can enhance memory consolidation in deep sleep and perhaps have some usefulness for people with mild cognitive impairment and other memory disorders.

Neely would love to see more applications investigated in the future.

“Inverse alpha stimulation [enhancing instead of suppressing the signal] could increase arousal,” he says. “That’s something I’d love to look into. And looking into mental-health treatment would be interesting, because phase coupling between the different brain regions appears to be an important factor in depression and anxiety disorders.”

Perry, who previously founded the wireless power startup UBeam, cofounded Elemind with four university professors with expertise in neuroscience, optogenetics, biomedical engineering, and artificial intelligence. The company has $12 million in funding to date and currently has 13 employees.

Preorders at $349 start today for beta units, and Elemind expects to start general sales later this year. The company will offer customers an optional membership at $7 to $13 monthly that will allow cloud storage of sleep data and access to new apps as they are released.

Last month when Google introduced its new AI search tool, called AI Overviews, the company seemed confident that it had tested the tool sufficiently, noting in the announcement that “people have already used AI Overviews billions of times through our experiment in Search Labs.” The tool doesn’t just return links to Web pages, as in a typical Google search, but returns an answer that it has generated based on various sources, which it links to below the answer. But immediately after the launch users began posting examples of extremely wrong answers, including a pizza recipe that included glue and the interesting fact that a dog has played in the NBA.

Renée DiResta has been tracking online misinformation for many years as the technical research manager at Stanford’s Internet Observatory.

While the pizza recipe is unlikely to convince anyone to squeeze on the Elmer’s, not all of AI Overview’s extremely wrong answers are so obvious—and some have the potential to be quite harmful. Renée DiResta has been tracking online misinformation for many years as the technical research manager at Stanford’s Internet Observatory and has a new book out about the online propagandists who “turn lies into reality.” She has studied the spread of medical misinformation via social media, so IEEE Spectrum spoke to her about whether AI search is likely to bring an onslaught of erroneous medical advice to unwary users.

I know you’ve been tracking disinformation on the Web for many years. Do you expect the introduction of AI-augmented search tools like Google’s AI Overviews to make the situation worse or better?

Renée DiResta: It’s a really interesting question. There are a couple of policies that Google has had in place for a long time that appear to be in tension with what’s coming out of AI-generated search. That’s made me feel like part of this is Google trying to keep up with where the market has gone. There’s been an incredible acceleration in the release of generative AI tools, and we are seeing Big Tech incumbents trying to make sure that they stay competitive. I think that’s one of the things that’s happening here.

We have long known that hallucinations are a thing that happens with large language models. That’s not new. It’s the deployment of them in a search capacity that I think has been rushed and ill-considered because people expect search engines to give them authoritative information. That’s the expectation you have on search, whereas you might not have that expectation on social media.

There are plenty of examples of comically poor results from AI search, things like how many rocks we should eat per day [a response that was drawn for an Onion article]. But I’m wondering if we should be worried about more serious medical misinformation. I came across one blog post about Google’s AI Overviews responses about stem-cell treatments. The problem there seemed to be that the AI search tool was sourcing its answers from disreputable clinics that were offering unproven treatments. Have you seen other examples of that kind of thing?

DiResta: I have. It’s returning information synthesized from the data that it’s trained on. The problem is that it does not seem to be adhering to the same standards that have long gone into how Google thinks about returning search results for health information. So what I mean by that is Google has, for upwards of 10 years at this point, had a search policy called Your Money or Your Life. Are you familiar with that?

I don’t think so.

DiResta: Your Money or Your Life acknowledges that for queries related to finance and health, Google has a responsibility to hold search results to a very high standard of care, and it’s paramount to get the information correct. People are coming to Google with sensitive questions and they’re looking for information to make materially impactful decisions about their lives. They’re not there for entertainment when they’re asking a question about how to respond to a new cancer diagnosis, for example, or what sort of retirement plan they should be subscribing to. So you don’t want content farms and random Reddit posts and garbage to be the results that are returned. You want to have reputable search results.

That framework of Your Money or Your Life has informed Google’s work on these high-stakes topics for quite some time. And that’s why I think it’s disturbing for people to see the AI-generated search results regurgitating clearly wrong health information from low-quality sites that perhaps happened to be in the training data.

So it seems like AI overviews is not following that same policy—or that’s what it appears like from the outside?

DiResta: That’s how it appears from the outside. I don’t know how they’re thinking about it internally. But those screenshots you’re seeing—a lot of these instances are being traced back to an isolated social media post or a clinic that’s disreputable but exists—are out there on the Internet. It’s not simply making things up. But it’s also not returning what we would consider to be a high-quality result in formulating its response.

I saw that Google responded to some of the problems with a blog post saying that it is aware of these poor results and it’s trying to make improvements. And I can read you the one bullet point that addressed health. It said, “For topics like news and health, we already have strong guardrails in place. In the case of health, we launched additional triggering refinements to enhance our quality protections.” Do you know what that means?

DiResta: That blog posts is an explanation that [AI Overviews] isn’t simply hallucinating—the fact that it’s pointing to URLs is supposed to be a guardrail because that enables the user to go and follow the result to its source. This is a good thing. They should be including those sources for transparency and so that outsiders can review them. However, it is also a fair bit of onus to put on the audience, given the trust that Google has built up over time by returning high-quality results in its health information search rankings.

I know one topic that you’ve tracked over the years has been disinformation about vaccine safety. Have you seen any evidence of that kind of disinformation making its way into AI search?

DiResta: I haven’t, though I imagine outside research teams are now testing results to see what appears. Vaccines have been so much a focus of the conversation around health misinformation for quite some time, I imagine that Google has had people looking specifically at that topic in internal reviews, whereas some of these other topics might be less in the forefront of the minds of the quality teams that are tasked with checking if there are bad results being returned.

What do you think Google’s next moves should be to prevent medical misinformation in AI search?

DiResta: Google has a perfectly good policy to pursue. Your Money or Your Life is a solid ethical guideline to incorporate into this manifestation of the future of search. So it’s not that I think there’s a new and novel ethical grounding that needs to happen. I think it’s more ensuring that the ethical grounding that exists remains foundational to the new AI search tools.

A thimbleful of soil can contain a universe of microorganisms, up to 10 billion by some estimates. Now a group of researchers in Bath, United Kingdom, are building prototype technologies that harvest electrons exhaled by some micro-species.

The idea is to power up low-yield sensors and switches, and perhaps help farmers digitally optimize crop yields to meet increasing demand and more and more stressful growing conditions. There could be other tasks, too, that might make use of a plant-and-forget, low-yield power source—such as monitoring canals for illegal waste dumping.

The research started small, based out of the University of Bath, with field-testing in a Brazilian primary school classroom and a green pond near it—just before the onset of the pandemic.

“We had no idea what the surroundings would be. We just packed the equipment we needed and went,” says Jakub Dziegielowski, a University of Bath, U.K. chemical engineering Ph.D. student. “And the pond was right by the school—it was definitely polluted, very green, with living creatures in it, and definitely not something I’d feel comfortable drinking from. So it got the job done.”

The experiments they did along with kids from the school and Brazilian researchers that summer of 2019 were aimed at running water purifiers. It did so. However, it also wasn’t very efficient, compared to, say, a solar panel.

So work has moved on in the Bath labs: in the next weeks, Dziegielowski will both turn 29 and graduate with his doctorate. And he, along with two other University of Bath advisors and colleagues recently launched a spinoff company—it’s called Bactery—to perfect a prototype for a network of soil microbial fuel cells for use in agriculture.

A microbial fuel cell is a kind of power plant that converts chemical energy stored in organic molecules into electrical energy, using microbes as a catalyst. It’s more often used to refer to liquid-based systems, Dziegielowski says. Organics from wastewater serve as the energy source, and the liquid stream mixes past the electrodes.

A soil microbial fuel cell, however, has one of its electrodes—the anode, which absorbs electrons—in the dirt. The other electrode, the cathode, is exposed to air. Batteries work because ions move through an electrolyte between electrodes to complete a circuit. In this case, the soil itself acts as the electrolyte—as well as source of the catalytic microbes, and as the source of the fuel.

The Bath, U.K.-based startup Bactery has developed a set up fuel cells powered by microbes in the soil—with, in the prototype pictured here, graphite mats as electrodes. University of Bath

Fields full of Watts

In a primary school in the fishing village of Icapuí on Brazil’s semi-arid northeastern coast, the group made use of basic components: graphite felt mats acting as electrodes, and nylon pegs to maintain spacing and alignment between them. (Bactery is now developing new kinds of casing.)

By setting up the cells in a parallel matrix, the Icapuí setup could generate 38 milliwatts per square meter. In work since, the Bath group’s been able to reach 200 milliwatts per square meter.

Electroactive bacteria—also called exoelectrogens or electricigens—take in soluble iron or acids or sugar and exhale electrons. There are dozens of species of microbes that can do this, including bacteria belonging to genera such as Geobacter and Shewanella. There are many others.

But 200 milliwatts per square meter is not a lot of juice: enough to charge a mobile phone, maybe, or keep an LED nightlight going—or, perhaps, serve as a power source for sensors or irrigation switches. “As in so many things, it comes down to the economics,” says Bruce Logan, an environmental engineer at Penn State who wrote a 2007 book, Microbial Fuel Cells.

A decade ago Palo Alto engineers launched the MudWatt, a self-contained kit that could light a small LED. It’s mostly marketed as a school science project. But even now, some 760 million people do not have reliable access to electricity. “In remote areas, soil microbial fuel cells with higher conversion and power management efficiencies would fare better than batteries,” says Sheela Berchmans, a retired chief scientist of the Central Electrochemical Research Institute in Tamil Nadu, India.

Korneel Rabaey, professor in the department of biotechnology at the University of Ghent, in Belgium, says electrochemical micro-power sources—a category that now includes the Bactery battery—is gaining buzz in resource recovery, for uses such as extracting pollutants from wastewater, with electricity as a byproduct. “You can think of many applications that don’t require a lot of power,” he says, “But where sensors are important.”

Tech startups are stepping up to meet the needs of 60 million people worldwide who use opioids, representing about 1 percent of the world’s adult population. In the United States, deaths involving synthetic opioids have risen 1,040 percent from 2013 to 2019. The COVID-19 pandemic and continued prevalence of fentanyl have since worsened the toll, with an estimated 81,083 fatal overdoses in 2023 alone.

Innovations include biometric monitoring systems that help doctors determine proper medication dosages, nerve stimulators that relieve withdrawal symptoms, wearable and ingestible systems that watch for signs of an overdose, and autonomous drug delivery systems that could prevent overdose deaths.

Helping Patients Get the Dosage They Need

For decades, opioid blockers and other medications that suppress cravings have been the primary treatment tool for opioid addiction. However, despite its clinical dominance, this approach remains underutilized. In the United States, only about 22 percent of the 2.5 million adults with opioid use disorder receive medication-assisted therapy such as methadone, Suboxone, and similar drugs.

Determining patients’ ideal dosage during the early stages of treatment is crucial for keeping them in recovery programs. The shift from heroin to potent synthetic opioids, like fentanyl, has complicated this process, as the typical recommended medication doses can be too low for those with a high fentanyl tolerance.

A North Carolina-based startup is developing a predictive algorithm to help clinicians tailor these protocols and track real-time progress with biometric data. OpiAID, which is currently working with 1,000 patients across three clinical sites, recently launched a research pilot with virtual treatment provider Bicycle Health. Patients taking Suboxone will wear a Samsung Galaxy Watch6 to measure their heart rate, body movements, and skin temperature. OpiAID CEO David Reeser says clinicians can derive unique stress indications from this data, particularly during withdrawal. (He declined to share specifics on how the algorithm works.)

“Identifying stress biometrically plays a role in how resilient someone will be,” Reeser adds. “For instance, poor heart rate variability during sleep could indicate that a patient may be more susceptible that day. In the presence of measurable amounts of withdrawal, the potential for relapse on illicit medications may be more likely.”

Nerve Stimulators Provide Opioid Withdrawal Relief

While OpiAID’s software solution relies on monitoring patients, electrical nerve stimulation devices take direct action. These behind-the-ear wearables distribute electrodes at nerve endings around the ear and send electrical pulses to block pain signals and relieve withdrawal symptoms like anxiety and nausea.

The U.S. Food and Drug Administration (FDA) has cleared several nerve stimulator devices, such as DyAnsys’ Drug Relief, which periodically administers low-level electrical pulses to the ear’s cranial nerves. Others include Spark Biomedical’s Sparrow system and NET Recovery’s NETNeuro device.

Masimo’s behind-the-ear Bridge device costs US $595 for treatment providers.Masimo

Similarly, Masimo’s Bridge relieves withdrawal symptoms by stimulating the brain and spinal cord via electrodes. The device is intended to help patients initiating, transitioning into, or tapering off medication-assisted treatment. In a clinical trial, Bridge reduced symptom severity by 85 percent in the first hour and 97 percent by the fifth day. A Masimo spokesperson said the company’s typical customers are treatment providers and correctional facilities, though it’s also seeing interest from emergency room physicians.

Devices Monitor Blood Oxygen to Prevent Overdose Deaths

In 2023, the FDA cleared Masimo’s Opioid Halo device to monitor blood oxygen levels and alert emergency contacts if it detects opioid-induced respiratory depression, the leading cause of overdose deaths. The product includes a pulse oximeter cable and disposable sensors connected to a mobile app.

Opioid Halo utilizes Masimo’s signal extraction technology, first developed in the 1990s, which improves upon conventional oxygen monitoring techniques by filtering out artifacts caused by blood movement. Masimo employs four signal-processing engines to distinguish the true signal from noise that can lead to false alarms; for example, they distinguish between arterial blood and low-oxygen venous blood.

Masimo’s Opioid Halo system is available over-the-counter without a prescription. Masimo

Opioid Halo is available over-the-counter for US $250. A spokesperson says sales have continued to show promise as more healthcare providers recommend it to high-risk patients.

An Ingestible Sensor to Watch Over Patients

Last year, in a first-in-human clinical study, doctors used an ingestible sensor to monitor vital signs from patients’ stomachs. Researchers analyzed the breathing patterns and heart rates of 10 sleep study patients at West Virginia University. Some participants had episodes of central sleep apnea, which can be a proxy for opioid-induced respiratory depression. The capsule transmitted this data wirelessly to external equipment linked to the cloud.

Celero’s Rescue-Rx capsule would reside in a user’s stomach for one week.Benjamin Pless/Celero Systems

“To our knowledge, this is the first time anyone has demonstrated the ability to accurately monitor human cardiac and respiratory signals from an ingestible device,” says Benjamin Pless, one of the study’s co-authors. “This was done using very low-power circuitry including a radio, microprocessor, and accelerometer along with software for distinguishing various physiological signals.”

Pless and colleagues from MIT and Harvard Medical School started Celero Systems to commercialize a modified version of that capsule, one that will also release an opioid antagonist after detecting respiratory depression. Pless, Celero’s CEO, says the team has successfully demonstrated the delivery of nalmefene, an opioid antagonist similar to Narcan, to rapidly reverse overdoses.

Celero’s next step is integrating the vitals-monitoring feature for human trials. The company’s final device, Rescue-Rx, is intended to stay in the stomach for one week before passing naturally. Pless says Rescue-Rx’s ingestible format will make the therapy cheaper and more accessible than wearable autoinjectors or implants.

Celero’s capsule can detect vital signs from within the stomach. www.youtube.com

Autonomous Delivery of Overdose Medication

Rescue-Rx isn’t the only autonomous drug-delivery project under development. A recent IEEE Transactions on Biomedical Circuits and Systems paper introduced a wrist-worn near-infrared spectroscopy sensor to detect low blood oxygen levels related to an overdose.

Purdue University biomedical engineering professor Hugh Lee and graduate student Juan Mesa, who both co-authored the study, say that while additional human experiments are necessary, the findings represent a valuable tool in counteracting the epidemic. “Our wearable device consistently detected low-oxygenation events, triggered alarms, and activated the circuitry designed to release the antidote through the implantable capsule,” they wrote in an email.

Lee and Purdue colleagues founded Rescue Biomedical to commercialize the A2D2 system, which includes a wristband and an implanted naloxone capsule that releases the drug if oxygen levels drop below 90 percent. Next, the team will evaluate the closed-loop system in mice.

This story was updated on 27 August 2024 to correct the name of Masimo’s Opioid Halo device.

Blood pressure is one of the critical vital signs for health, but standard practice can only capture a snapshot, using a pressure cuff to squeeze arteries. Continuous readings are available, but only by inserting a transducer directly into an artery via a needle and catheter. Thanks to researchers at Caltech, however, it may soon be possible to measure blood pressure continuously at just about any part of the body.

In a paper published in July in PNAS Nexus, the researchers describe their resonance sonomanometry (RSM) approach to reading blood pressure. This new technology uses ultrasound to measure the dimensions of artery walls. It also uses sound waves to find resonant frequencies that can reveal the pressure within those walls via arterial wall tension. This information is sufficient to calculate the absolute pressure within the artery at any moment, without the need for calibration.

This last factor is important, as other non-invasive approaches only provide relative changes in blood pressure. They require periodic calibration using readings from a traditional pressure cuff. The RSM technology eliminates the need for calibration, making continuous readings more reliable.

How resonance sonomanometry works

The researchers’ RSM system uses an ultrasound transducer to measure the dimensions of the artery. It also transmits sound waves at different frequencies. The vibrations cause the arterial walls to move in and out in response, creating a distinct pattern of motion. When the resonant frequency is transmitted, the top and bottom of the artery will move in and out in unison.

This resonant frequency can be used to determine the tension of the artery walls. The tension in the walls is directly correlated with the fluid pressure of the blood within the artery. As a result, the blood pressure can be calculated at any instant based on the dimensions of the artery and its resonant frequency.

The researchers have validated this approach with both mockups and human subjects. They first tested the technology on an arterial model that used a thin-walled rubber tubing and a syringe to vary the pressure. They tested this mockup using multiple pressures and tubing of different diameters.

The researchers then took measurements with human subjects at their carotid arteries (located in the neck), using a standard pressure cuff to take intermittent measurements. The RSM technology was successful, and subsequently was also demonstrated on axillary (shoulder), brachial (arm), and femoral (leg) arteries. The readings were so clear that the researchers mention that they might even be able to detect blood pressure changes related to respiration and its impact on thoracic pressure.

Unlike traditional pressure cuff approaches, RSM provides data during the entire heartbeat cycle, and not just the systolic and diastolic extremes (In other words, the two numbers you receive during a traditional blood pressure measurement). And the fact that RSM works with different-sized arteries means that it should be applicable across different body sizes and types. Using ultrasound also eliminates possible complications such as skin coloration that can affect light-based devices.

The researchers tested their ultrasound-based blood pressure approach on subjects’ carotid arteries.Esperto Medical

“I’m a big fan of continuous monitoring; a yearly blood pressure reading in the doctor’s office is insufficient for decision making,” says Nick van Terheyden, M.D., the digital health leader with Iodine Software, a company providing machine learning technologies to improve healthcare insights. “A new approach based on good old rules of math and physics is an exciting development.”

The Caltech researchers have created a spinoff company, Esperto Medical, to develop a commercial product using RSM technology. The company has created a transducer module that is smaller than a deck of cards, making it practical to incorporate into a wearable armband. They hope to miniaturize the hardware to the point that it could be incorporated into a wrist-worn device. According to Raymond Jimenez, Esperto Medical’s chief technology officer, “this technology poses the potential to unlock accurate, calibration-free [blood pressure measurements] everywhere—in the clinic, at the gym, and even at home.”

It appears that there’s a significant market for such a product. “92 percent of consumers who intend to buy a wearable device are willing to pay extra for a health-related feature, and blood pressure ranks first among such features,” says Elizabeth Parks, the president of Internet of Things consulting firm Parks Associates.

In the future, rather than relying on arm-squeezing blood pressure cuffs, smart watches may be able to directly monitor blood pressure throughout the day, just as they already do for heart rate and other vital signs.

Manu Prakash spoke with IEEE Spectrum shortly after returning to Stanford University from a month aboard a research vessel off the coast of California, where he was testing tools to monitor oceanic carbon sequestration. The associate professor conducts fieldwork around the world to better understand the problems he’s working on, as well as the communities that will be using his inventions.

Prakash develops imaging instruments and diagnostic tools, often for use in global health and environmental sciences. His devices typically cost radically less than conventional equipment—he aims for reductions of two or more orders of magnitude. Whether he’s working on pocketable microscopes, mosquito or plankton monitors, or an autonomous malaria diagnostic platform, Prakash always includes cost and access as key aspects of his engineering. He calls this philosophy “frugal science.”

Why should we think about science frugally?

Manu Prakash: To me, when we are trying to ask and solve problems and puzzles, it becomes important: In whose hands are we putting these solutions? A frugal approach to solving the problem is the difference between 1 percent of the population or billions of people having access to that solution.

Lack of access creates these kinds of barriers in people’s minds, where they think they can or cannot approach a kind of problem. It’s important that we as scientists or just citizens of this world create an environment that feels that anybody has a chance to make important inventions and discoveries if they put their heart to it. The entrance to all that is dependent on tools, but those tools are just inaccessible.

How did you first encounter the idea of “frugal science”?

Prakash: I grew up in India and lived with very little access to things. And I got my Ph.D. at MIT. I was thinking about this stark difference in worlds that I had seen and lived in, so when I started my lab, it was almost a commitment to [asking]: What does it mean when we make access one of the critical dimensions of exploration? So, I think a lot of the work I do is primarily driven by curiosity, but access brings another layer of intellectual curiosity.

How do you identify a problem that might benefit from frugal science?

Prakash: Frankly, it’s hard to find a problem that would not benefit from access. The question to ask is “Where are the neglected problems that we as a society have failed to tackle?” We do a lot of work in diagnostics. A lot [of our solutions] beat the conventional methods that are neither cost effective nor any good. It’s not about cutting corners; it’s about deeply understanding the problem—better solutions at a fraction of the cost. It does require invention. For that order of magnitude change, you really have to start fresh.

Where does your involvement with an invention end?

Prakash: Inventions are part of our soul. Your involvement never ends. I just designed the 415th version of Foldscope [a low-cost “origami” microscope]. People only know it as version 3. We created Foldscope a long time ago; then I realized that nobody was going to provide access to it. So we went back and invented the manufacturing process for Foldscope to scale it. We made the first 100,000 Foldscopes in the lab, which led to millions of Foldscopes being deployed.

So it’s continuous. If people are scared of this, they should never invent anything [laughs], because once you invent something, it’s a lifelong project. You don’t put it aside; the project doesn’t put you aside. You can try to, but that’s not really possible if your heart is in it. You always see problems. Nothing is ever perfect. That can be ever consuming. It’s hard. I don’t want to minimize this process in any way or form.

Acadia Pharmaceuticals did not disclose the buyer of the priority review voucher. The biotech received the voucher last year alongside the regulatory decision that made its drug Daybue the first FDA-approved treatment for the rare disease Rett syndrome.

The post Acadia Pharma Sells Voucher for Speedier FDA Drug Review for $150M appeared first on MedCity News.

Three ways health plans can engage, connect with, and delight their pregnant members to nurture goodwill, earn long-term trust, and foster loyal relationships that last.

The post Pregnant and Empowered: Why Trust is the Latest Form of Member Engagement appeared first on MedCity News.

Navigating the regulatory and ethical requirements of different medical data providers across many different countries, as well as safeguarding patient privacy, is a mammoth task that requires extra resources and expertise.  

The post AI is Revolutionizing Healthcare, But Are We Ready for the Ethical Challenges?  appeared first on MedCity News.

Many companies are entering the digital youth mental health space, but it’s important to know which ones are effective, according to a panel of investors at the Behavioral Health Tech conference.

The post Measuring Impact in Digital Youth Mental Health: What Investors Look For appeared first on MedCity News.

Two executives at behavioral health care companies discussed why it’s important for provider organizations to partner with the 988 Suicide & Crisis Lifeline during a panel at the Behavioral Health Tech conference.

The post There’s an Opportunity for More Providers to Partner with the 988 Lifeline, Execs Say appeared first on MedCity News.

Top challenges impacting specialty pharmacy outcomes, and how health systems may achieve efficiencies and enhance performance for optimal outcomes.

The post An Integrated Approach to Optimizing Specialty Pharmacy and Accelerating Performance appeared first on MedCity News.

Fort Health’s $5.5 million in funding was led by Twelve Below and Vanterra and included participation from Redesign Health, Blue Venture Fund and True Wealth Ventures.

The post Fort Health Secures $5.5M to Expand Access to Integrated Pediatric Mental Health Care appeared first on MedCity News.

In 2018, opioid overdoses in the United States caused one death every 11 minutes, resulting in nearly 47,000 fatalities. The most effective treatments for opioid use disorder (OUD) are three medications approved by the Food and Drug Administration (FDA): methadone, buprenorphine, and naltrexone.

Breaking COVID-19’s chain of transmission requires effective physical distancing, contact tracing and rapid analyses of demographic data to reveal illness clusters and populations at high risk, such as people older than 65, Latinos and Blacks.

Dr. Cassandra Quave’s path to her work as a leader in antibiotic drug discovery research initiatives at Emory University in Atlanta started when she was a child and she and her family dealt with her own serious health issues that have had life-long repercussions.

Between 1999 and 2014, opioid use disorder (OUD) among pregnant women more than quadrupled, risking the health of the women—before and after giving birth—and their infants. As states grapple with COVID-19’s exacerbation of the opioid crisis, several are taking innovative steps to address the needs of high-risk groups, including low-income, postpartum patients with OUD.

Over the past year, COVID-19 has taken a grave toll in lives as well as on medical and health care systems worldwide. The pandemic has laid bare the importance of public health readiness and the myriad consequences when such a crisis strikes an unprepared population.

The Pew Charitable Trusts today commended Michigan Governor Gretchen Whitmer (D), state Senate Majority Leader Mike Shirkey (R), and Lee Chatfield (R)—whose term as state House Speaker ended last month—for passing and signing a bipartisan package of bills aimed at protecting public safety while reducing the number of people in county jails.

As the coronavirus pandemic grips the world, the opioid epidemic continues to affect millions of Americans. Several states are developing innovative ways to tackle this public health issue. In this episode, we speak with Beth Connolly, who leads Pew’s research on substance use disorders, and Louisiana Representative Paula Davis, who helped ensure effective treatment in her state.

Sales of medically important antibiotics for use in food-producing animals increased 3% in 2019, according to recent data from the U.S. Food and Drug Administration. This is the second year in a row that the quantities of antibiotics sold for animal use have risen, underscoring the need for further FDA action to ensure judicious use of these lifesaving drugs.

Technology has revolutionized the way people live their lives. Individuals can use smartphones to access their bank account, shop from almost any store, and connect with friends and family around the globe. In fact, these personal devices have tethered communities together during the coronavirus pandemic, allowing many people to maintain much of their lives remotely.

After four years of negotiations, European lawmakers agreed on June 15 on a new EU Medical Devices Regulation (MDR). The MDR is the equivalent to the FDA’s CDRH regulations in the United States and essentially specifies the applicable rules when importing medical devices into Europe, which is the world’s second-largest device market. Rules relate, for...… Continue Reading