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Medtronic’s recall of more than 348,000 implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) has been deemed class I by the FDA, the most serious type of recall as use of the device may cause injury or death. Read More
The Department of Justice (DOJ) and the FTC have issued draft guidelines the government will use to determine whether a merger may violate anti-trust laws by risking lessened competition now and in the future. Read More
CMS has proposed removing the national coverage determination for the positron emission tomography (PET) beta amyloid imaging needed to diagnose the onset of Alzheimer’s disease and prescribe the newly approved antiamyloid antibody drug Lequembi (lecanemab). Read More
The FTC is withdrawing two antitrust policy statements related to enforcement in healthcare markets that it says no longer reflect market realities at the same time it demonstrates its intentions by pursuing administrative actions against two pending mergers. Read More
Final guidance on a voluntary program for qualifying medical device development tools (MDDT) for the evaluation of devices regulated by CDRH has been reissued by the FDA with minor process clarifications. Read More
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
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