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French in vitro diagnostics company bioMérieux is contributing its expertise to a joint venture to develop both diagnostics and antimicrobials to fight pathogens that have evolved into antimicrobial resistance (AMR). Read More
Seno Medical Instruments received a Form 483 after the FDA inspected its San Antonio, Texas, facility last February and March, listing inadequate design control procedures and other lapses. Read More
Remidio, an India-based medical device company that develops eye testing technology using AI and telemedicine integrated devices, announced clinical trial results showing that its Medios Al algorithm can help detect patients with “referable” glaucoma. Read More
The device requires less than one liter of liquid helium and, unlike many MRI systems, does not require a quench pipe to expel helium out of the building. Read More
The European Commission has issued a regulation for manufacturers of high-risk, Class D in vitro diagnostics, giving them two years to comply with the EU’s In Vitro Diagnostic Regulation (IVDR). Read More
NeuroEM Therapeutics announced that its MemorEM medical device has shown the ability to “re-balance” the immune system in Alzheimer’s Disease patients enrolled in a clinical trial. Read More
The FDA approved Imcivree in 2020 for chronic weight management in adult and pediatric patients six years of age and older with obesity due to POMC, PCSK1 or LEPR deficiency. Read More