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A genetic risk assessment for opioid addiction approved by the FDA “may make the opioid crisis worse,” according to 31 physicians, researchers and scientists who ripped the agency and the test in a scathing letter Thursday to Commissioner Robert Califf, requesting the approval be revoked. Read More
Over the past week, the FDA published two final guidances on electronic submissions. Draft guidance was issued on data integrity for in vivo BA/BE studies. The agency is also seeking nominations for members on two advisory committees. Read More
While Johnson & Johnson just announced its plans to acquire Shockwave Medical for $13.1 billion, Boston Scientific faces an FTC request for more information on its $3.7 billion acquisition of Axonics. Read More
The first-ever sepsis diagnostic powered by AI has been granted De Novo marketing authorization by the FDA, addressing a decades-long and expensive challenge for the U.S. healthcare system — rapid diagnosis and prediction of sepsis. Read More
Three medical devices — radial artery and arterial line catheterization kits, a neurovascular catheter, and gas-powered portable ventilators — have been deemed Class I, the FDA’s most serious type of recall. Read More
Seeking to get back on track for FDA approval of its first-of-a-kind epinephrine nasal spray, ARS Pharmaceuticals says it has provided the agency with responses to all its additional requests in the Complete Response Letter (CRL) the agency send ARS last September. Read More
This edition of Quick Notes reviews the FDA’s clearance of Abbott’s hand-held rapid blood test for traumatic brain injury, Eko’s AI-powered stethoscope that can detect low ejection fraction (EF), Beacon’s machine learning software that scores sleep stages, and Calyxo’s redesigned kidney stone CVAC System. Read More
The FDA questioned and answered virtually all aspects of Remote Regulatory Assessments (RRA) in an 18-page revised draft guidance issued last January, and the comments on the Q&A document have arrived with more questions of their own. Read More
New draft guidance for ceramic and metal coatings on implantable orthopedic devices needs to recognize the different bonding characteristics of a new generation of extremely thin, nonporous metallic coatings applied by ion beam deposition, according to one of seven comments filed on the document. Read More