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AdvaMed, a trade group for medical devicemakers, did not submit a public comment but instead issued a statement on the subject in late September. Read More
In this edition of Quick Notes, we look at expanded clearance for a smart watch, a retinal camera with designs on uncovering health problems, new software to better track neurological disease and a way to increase radiologists’ efficiency by enabling remote review of MRI scans. Read More
Roche has announced the $2.7 billion acquisition of Carmot Therapeutics, including that company’s three potential incretin obesity and diabetes drugs. Read More
Recalled glucose capsules marketed as a health supplement for blood glucose control were found to contain glyburide and metformin — drugs that treat type 2 diabetes by lowering blood sugar — were deemed a Class I recall by the FDA, the most serious type of recall as use may cause serious injuries or death. Read More
As the first session of the 118th Congress continues, FDAnews will track important pending legislation, that has been acted on since July 1, to keep you updated on laws and regulations that could impact your business. Read More
In a strongly worded position paper, the European Commission’s Medical Device Coordination Group (MDCG) has directed device manufacturers to get certified ASAP under the new device and diagnostics regulations. Read More
Leaks, breakage and other problems with plastic syringes manufactured in China have led the FDA to urge all users to check the manufacturing location of syringes and consider not using them while it considers preventing syringes made in China from entering the U.S. Read More
Over the past week, the FDA issued proposed rules to classify certain types of wound dressings and liquid wound washes containing antimicrobials and/or other chemicals and to require premarket approval applications for certain solid wound dressings; wound dressings formulated as a gel, cream, or ointment and liquid wound washes containing antimicrobials with a high level of antimicrobial resistance. Read More
Eitan Medical’s recall of 1,323 infusion pumps — for a risk that the pump may fail to detect air in the line when running on battery power — has been identified by the FDA as Class I, the most serious type of recall as use of these devices may cause serious injuries or death. Read More