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Databazaar of Miramar, Fla. drew a warning letter from the FDA for marketing KN95 masks as providing protection against COVID-19 without marketing approval, clearance or authorization from the agency. Read More
The Justice Department has been going after “promoters” who fraudulently convince healthcare providers to bill the federal government for electro-acupuncture, or who market peri-auricular stimulation (P-Stim) devices using that as a selling point. Read More
The notified bodies that certify medical devices with a CE mark in the European Union are concerned that the EU may end up over-regulating the industry through its proposed regulation on artificial intelligence (AI). Read More
Scrambling to clear COVID-19 testing backlogs that have persisted all year, the Biden administration has disbursed more than $562 million to stimulate manufacturing and distribution of the kits over the next two years. Read More
A bill that would replenish the national stockpile of devices and other medical products for use in national emergencies passed the House of Representatives with an overwhelming bipartisan majority of 397-22 last week. Read More
The International Medical Device Regulators Forum (IMDRF) is seeking comments on a draft guidance on machine learning-enabled medical devices (MLMD) that aims to “support global harmonization and provide a foundation of future guidelines.” Read More
Magnolia Medical Technologies, developer of the Steripath Gen 2 blood collection system, drew a warning letter from the FDA for qualify failures observed during a June 3 to July 15 inspection of its Seattle premises. Read More
The Advanced Medical Technology Association (AdvaMed) has proposed a modified plan for the Centers for Medicare & Medicaid Services (CMS) to pay for breakthrough devices, after the agency withdrew its proposal to do so. Read More
The FDA has called on manufacturers of ENFit low-dose tip (LDT) syringes to update their labeling to reduce the risk that their products will lead to accidental overdoses. Read More
The FDA is trying to address barriers to more widespread use of over-the-counter (OTC) hearing aids, including cost, access and state and federal regulations, through a proposed rule and draft guidance published today in the Federal Register. Read More