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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
Masimo announced results from a two-part study showing that its SafetyNet monitoring system can help COVID-19 patients decrease their length of hospital stay. Read More
Enovis has teamed up with Inglewood, Calif.-based Kelvi, a developer of digital hot and cold therapy products, to supply therapies for rehabilitation, recovery and performance enhancement for patients and athletes. Read More
Sens. Elizabeth Warren (D-Mass.) and Chuck Grassley (R-Iowa) accused leading device manufacturers of trying to "undermine" the availability of over-the-counter hearing aids, in a newly published report. Read More