The FDA has rejected Artrya Ltd.’s 510(k) application for its Salix coronary anatomy (SCA) software that analyzes heart computed tomography scans via artificial intelligence (AI) to better diagnose coronary artery disease. “The FDA has advised that the Artrya Salix product is not equivalent to the predicate device,” Artrya CEO John Barrington told BioWorld.
Medical device supply chain considerations became especially salient during the COVID-19 pandemic, but the U.S. FDA is interested in ensuring that supply chains do not hamper patient access going forward. However, Clayton Hall of the Medical Device Manufacturers Association (MDMA) said on a recent FDA webinar that device makers are sometimes at the mercy of their suppliers.
Just three months after raising $10 million from its IPO on the Paris Euronext Growth market, SMAIO SA (Software Machines and Adaptive Implants in Orthopedics) obtained U.S. FDA 510(k) clearance for its Balance Analyzer 3D surgery planning software and for its patient-specific union rods. This spinal realignment planning software uses medical imaging of the patient’s spine in an upright static position.
The U.S. FDA is among the regulators that are taking account of the views of patients in medical device development and regulation, but artificial intelligence (AI) and machine learning (ML) are terra incognita for many, if not most patients. Rebekah Angove, vice president for patient experience and program evaluation at the Patient Insight Institute, told BioWorld that while some patients clearly want to know more about AI and ML, it is also clear that more than a certain amount of detail is more of a distraction than a help for most patients.
The U.S. FDA’s Psychopharmacologic Drugs Advisory Committee took up the complicated matter of Acadia Pharmaceuticals Inc.’s sNDA for Nuplazid (pimavanserin) to treat hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP).
Just days after U.S. FDA advisors unanimously backed use of both the Moderna Inc. and Pfizer Inc.-Biontech SE COVID-19 vaccines in children 6 months and older, the FDA has expanded emergency use authorizations for the products. Availability could follow as soon as June 21, after a meeting of the CDC’s ongoing Advisory Committee on Immunization Practices, wraps up June 18.
What was billed as a U.S. Senate Health, Education, Labor and Pensions Committee hearing June 16 to get an update from top government health officials on the nation’s response to COVID-19 was, in reality, a concerted effort to get Republicans in the U.S. Senate to open the checkbook so the Biden administration could fill in the amount for more COVID-19 spending, Ranking Member Richard Burr (R-N.C.) charged as he concluded the hearing.
In keeping with the 21st Century Cures Act, the U.S. FDA issued a draft guidance describing a standards recognition program for regenerative medicine therapies at the Center for Biologics Evaluation and Research that’s intended to facilitate the development of the therapies and reduce the regulatory burden.
After a two-day session of the FDA’s Vaccines and Related Biologic Products Advisory Committee, the U.S. is within days of a long-awaited milestone of having not just one but at least two vaccines available for nearly every American. The VRBPAC voted unanimously, 21-0, June 15 to support amending the emergency use authorizations for both the Moderna Inc. and Pfizer Inc.-Biontech SE COVID-19 mRNA vaccines to allow their use in children 6 months and older.
The FDA’s Psychopharmacologic Drugs Advisory Committee posted briefing documents related to the June 17 meeting, set to consider Acadia Pharmaceuticals Inc.’s sNDA for Nuplazid (pimavanserin) to treat hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP). Although shares of the San Diego-based firm (NASDAQ:ACAD) stayed in the black, closing at $18.77, up $2.52, or 15.5%, the briefing docs did not bring uniformly good news, echoing some of the concerns spelled out in an earlier complete response letter.
RSS
