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After analyzing four additional years of data, the FDA has decided to reverse its 2019 judgment of the mortality risk of paclitaxel-coated devices, saying data do not support a finding of excess mortality risk. Read More
The FDA’s recent final guidance on clinical decision support software prevents physicians from fully disclosing critical health information and therefore violates the First Amendment, a Florida law professor has written in her citizen petition to the FDA. Read More
Dubbing the Patent Trial Appeal Board’s (PTAB) rationale “doubly infected by error,” the U.S. Federal Court of Appeals gave Axonics the win as it vacated PTAB’s denial of Axonics appeal against Medtronic and remanded the case back to PTAB for reconsideration. Read More
Megadyne, an Ethicon company, is recalling its Mega 2000 and Megasoft reusable patient return electrodes — now deemed an FDA class I recall, the most serious type of recall as use of the device could lead to serious injury or death — after receiving reports of burn injuries as serious as third degree. Read More
The FDA has classified Draeger Medical’s Oxylog 3000 Plus emergency and transport ventilator as class I, the most serious type of recall because of the risk of serious injury or death. Read More
Nearly 20 percent of AI and machine learning (ML) devices in a study had discrepancies between FDA-cleared indications for use and information included in marketing materials, according to a report published Wednesday in JAMA Open Network.. Read More
The Case for Quality (CfQ) — an FDA initiative in which the agency works closely with the public-private partnership the Medical Device Innovation Consortium (MDIC) — has key programs coming to fruition in its mission to get the industry to focus on continuous improvement in their quality operations. Read More