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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The FDA questioned and answered virtually all aspects of Remote Regulatory Assessments (RRA) in an 18-page revised draft guidance issued last January, and the comments on the Q&A document have arrived with more questions of their own.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New draft guidance for ceramic and metal coatings on implantable orthopedic devices needs to recognize the different bonding characteristics of a new generation of extremely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
Can remote cognitive testing via smartphones yield reliable and valid data to evaluate people for a type of dementia? Findings of a study of 360 individuals spanning over four and a half years indicate the answer is yes. Read More
As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws and regulations that could impact your business. Read More
Three FDA final guidances address electronic submissions for reporting adverse reactions — one for investigational new drug application (IND) safety reports, one for transmitting electronic individual case safety reports (ICSR), another for ICSR attachments to the FDA Adverse Event Reporting System (FAERS) database and a third for expedited ICSRs from certain IND-exempt studies. Read More