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The FDA has cleared several impactful devices this week — one that can predict a dangerous pregnancy complication, one that measures heart arrhythmias for up to six years after insertion just under the skin, and one that can detect the brain plaque associated with Alzheimer’s in under five minutes. Read More
A five-year study of patients with acute coronary syndrome (ACS) revealed no notable difference in long-term clinical outcomes between those treated with titanium-nitride-oxide (TiNO)-coated stents or everolimus drug eluting stents (EES), both of which are used to widen narrow or blocked coronary arteries. Read More
Over the past week, the FDA issued notices of draft guidances on pediatric research, a final decision on withdrawal of Makena and a determination on Catapres products. Read More
CDRH Director Jeffrey Shuren aims to reverse a historical trend and make the U.S. the top destination for novel medical device launches, improving the center’s efficiency along the way. Read More
Clinical trial sites venturing into the growing field of digital therapeutics (DTx) need the appropriate infrastructure — as well as tech know-how and adaptability — while sponsors need to be willing to offer training and support, iron out hurdles that come with remote components and simplify these trials whenever possible, a clinical research expert advises. Read More
Upcoming events in the coming weeks include six FDA advisory committee meetings as well as webinars and conferences on subjects ranging from IVDs and LDTs, developing SOPs and pharmaceutical quality risk management. Read More
Philips Respironics reports risk assessments of its continuous positive airway pressure (CPAP) and bi-level positive airway pressure (BiPAP) sleep apnea therapy devices showed that degraded sound abatement foam on the devices would likely not cause “appreciable harm” to patient health. Read More
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on regulations that could impact your business. Read More