By: Daniel Logan and Justine Johnson The Coronavirus Aid, Relief, and Economic Security Act, or “CARES” Act (Pub. L. No. 116–136) makes numerous changes to the Federal Food, Drug, and Cosmetic Act (FDCA).  The CARES Act made substantial changes related to the regulation of over-the-counter (OTC) drugs (see KKB’s alert here dedicated to summarizing these

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Join Kleinfeld, Kaplan & Becker, LLP and Vicente Sederberg on Tuesday, April 7 at 2:15 p.m. ET for a live webinar on Hemp and CBD – FDA Update and the Impact of COVID-19. Since 2015, KKB and VS have worked closely together in advising clients on the ever-evolving legal landscape for hemp-derived products. During this

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#TTB just made changes to modernize the way that #wine, #distilledspirits, and #maltbeverages are labeled and advertised. KKB associate Dan Logan and partner Dan Dwyer highlight some of the key changes (and proposals that were rejected).

The post TTB Finalizes Portions of Modernization of Advertising and Labeling Regulations for Wine, Distilled Spirits, and Malt Beverages Rule appeared first on Kleinfeld Kaplan & Becker LLP.

We are pleased to announce that KKB partners Dan Dwyer, Stacy Ehrlich, Peter Mathers, and Suzan Onel were selected for the annual Super Lawyers list for Washington, DC.  They make up more than 20% of the 18 DC attorneys listed in the “Food and Drugs” category.  In addition, for the sixth year in a row, KKB

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Researchers at the University of Bath in the UK have developed a 3D-printed microscope design, called OpenFlexure, which is open-source and can be assembled for as little as $18. More complex versions of the design are possible, and the microscope can incorporate full automation and a Raspberry Pi computer. The research team hopes that the […]

Researchers at the National University of Singapore have developed a soft sensor and actuator to monitor bladder volume and help empty it on-demand. The device is intended to be implanted on the bladder surface during a surgical procedure to treat patients who cannot completely empty their bladders voluntarily. Patients can suffer from an underactive bladder […]

ZOLL Medical, a part of the Asahi Kasei Group, won EU clearance for its SuperSaturated Oxygen (SSO2) Therapy System to be used to minimize the damage that heart attacks cause within heart muscle. Approved about a year ago in the United States, SSO2 is the only option beyond percutaneous coronary intervention (stenting) that can help […]

The current pandemic is revealing the level of commitment needed from multiple sectors to deliver innovative solutions to tackle severe shortages of personal protective equipment, ventilators, and raw materials. Researchers at the Prakash lab at Stanford University are no stranger to taking up extreme challenges, and they have kept up their reputation by coming up […]

As the COVID-19 pandemic continues, many healthcare facilities around the world are inundated with critically ill patients, and resources such as equipment and staff are stretched thin. Shortages of critical equipment, such as ventilators, can mean the difference between life and death for patients, and the need to keep critically ill patients comfortable and alive […]

Researchers at Purdue University have developed a new technique to dramatically enhance the resolution achievable when imaging intracellular structures with super-resolution fluorescence microscopy. The technique uses the distortions created by a specimen to pinpoint the location of individual molecules, and thereby infer the location of intracellular structures. The technique could be particularly useful in studying […]

BioIntelliSense, a Silicon Valley company, is unveiling its FDA cleared BioButton device that may help with tracking symptoms of COVID-19 in potential patients and help society return to a normal state of affairs. The BioButton is about the size of a large coin and, with the help of accompanying applications and triage dashboards, it can […]

According to the World Health Organization, 47% of childhood deaths worldwide occur in the first four weeks of life. This neonatal mortality rate is particularly prevalent in sub-Saharan Africa, where nearly one million newborns die every year. Many of these deaths can be prevented with medical devices that more developed countries often take for granted, […]

In the era of COVID-19, surgical masks are a necessity for all healthcare workers and an effective way to curtail the spread of the virus within the general public. Since surgical masks are still in relatively short supply, companies and researchers have been working on ways to make available masks last longer. Cleanbox Technology, based […]

LifeSignals, based in Fremont, California, announced that it received the CE Mark for its LifeSignals ECG Remote Monitoring Patch. The patch, integrated with a remote monitoring platform, is designed as a continuous electrocardiography (ECG) and heart rate monitor. The ECG Remote Monitoring Patch is disposable and captures data for up to three days. The device […]

VitalConnect announced that it has received FDA Emergency Use Authorization status for use of its VitalPatch to detect changes in the QT interval of hospitalized patients undergoing drug treatment for COVID-19. Hydroxychloroquine and chloroquine, used to treat some COVID-19 patients, are associated with risk of prolonged QT interval that can lead to life-threatening arrhythmias. VitalPatch allows […]

Adhesives specialist Intertronics has launched the preeflow eco-DUOMIX, a system that mixes and dispenses two-part materials.

Medical device manufacturer, Boddingtons, has lately been resourcing fast-tooling and moulding projects in relation to emergency procurement for the Covid-19 crisis.

MedTech Europe has issued a statement welcoming the delay for enforcing the European Medical Devices Regulation (EU MDR), and asking for similar action for the In Vitro Diagnostic Regulation (IVDR).

Since early February, custom material solutions provider, Compounding Solutions, has been working hard to meet material demands related to Covid-19.

In light of Covid-19, Smithers Thermoplastic and Silicone Elastomers US Summits will now take place in a virtual format.