U.S. Trade Representative Katherine Tai announced this afternoon that the Biden administration supports waiving IP protections for COVID-19 vaccines. “This is a global health crisis, and the extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures,” Tai said in the statement. Get the full story on our sister site Pharmaceutical Processing World.
Regulatory/Compliance
Pfizer to seek FDA approval for COVID-19 vaccine, will seek authorization for kids above 2
Pfizer CEO Albert Bourla said the company will soon seek full FDA approval and authorization for further age groups for its COVID-19 vaccine. Speaking during the company’s first-quarter earnings call yesterday, transcribed by The Motley Fool, Bourla outlined the regulatory pathways that the company is pursuing for the vaccine it developed with BioNTech, which is […]
FDA clears Life Spine’s ProLift lateral HELO fixation system
Life Spine announced today that it received FDA marketing clearance for its ProLift lateral HELO fixation system. Huntley, Ill.-based Life Spine touts the ProLift lateral HELO fixation system, an expendable lateral spacer with an integrated plating system designed for the restoration of disc height while providing additional lateral stabilization, as capable of saving time and […]
Cerapedics’ bone graft gains FDA breakthrough nod
Ortho-biologics company Cerapedics announced that it has won FDA breakthrough device designation for its investigational P-15L bone graft to treat degenerative disc disease (DDD). The company plans to enroll at least 270 DDD patients in the Aspire study, a prospective, single-blinded, multi-center, randomized, non-inferiority pivotal IDE study to evaluate the safety and efficacy of P-15L bone graft […]
FDA revokes Battelle mask decontamination EUA
The FDA has revoked its authorization for Battelle Memorial Institute to decontaminate used N95 respirators for healthcare workers. In a letter dated April 30, 2021, the agency said it revoked the EUA at Battelle’s request. The Columbus, Ohio-based research organization asked to withdraw the EUA for its Critical Care Decontamination System (CCDS) in an April 2 letter. […]
Medtronic wins CE mark approval for Evolut Pro+ TAVI system
Medtronic (NYSE:MDT) announced today that it received CE mark approval for its next-generation Evolut Pro+ TAVI system. Fridley, Minn.-based Medtronic’s Evolut Pro+ transcatheter aortic valve implantation (TAVI) system is the newest version of the company’s self-expanding, supra-annular Evolut TAVI platform. It won U.S. FDA approval in 2019. The latest edition of the platform includes four […]
BD’s Alaris pump hit with another serious recall
A medical supply company is recalling BD (NYSE:BDX) Alaris infusion pumps — the third Class I recall for the pumps in recent months, according to the FDA. North Carolina-based Avante Health Solutions issued the Alaris pump recall March 24, 2021, because the bezel repair posts may crack or separate, leading to the inaccurate delivery of […]
AtriCure AFib treatment device wins FDA approval
AtriCure (NSDQ:ATRC) announced today that the FDA approved its EPi-Sense system for treating long-standing persistent atrial fibrillation (Afib). Mason, Ohio-based AtriCure’s EPi-Sense system demonstrated superiority in the Hybrid AF therapy arm compared to endocardial catheter ablation alone in the Converge clinical trial, according to a news release. AtriCure’s Hybrid AF therapy is a minimally invasive […]
Phoenix Cardiac wins CE mark for mitral regurgitation device
Phoenix Cardiac Devices announced that it received CE mark approval for its BACE device for treating functional mitral regurgitation (FMR). BACE (basal annuloplasty of the cardiac externally) is a novel modality for treating FMR and is touted as the only surgical device with long-term clinical data demonstrating significant benefit by addressing the root cause of […]
Canada approves J&J Vision’s drug-eluting contact lens
Johnson & Johnson Vision announced today that it received Health Canada approval for its Acuvue Theravision drug-eluting contact lens. Jacksonville, Fla.-based J&J Vision’s Acuvue Theravision with Ketotifen is touted as the first and only vision-correcting contact lens that relieves allergic eye itch through drug delivery. The company received Japanese approval for the lens last month. Get the […]
Medtronic wins FDA breakthrough nod for Emprint ablation catheter kit
Medtronic (NYSE:MDT) announced today that it received FDA breakthrough device designation for its Emprint ablation catheter kit. Fridley, Minn.-based Medtronic’s catheter is designed to be used in conjunction with the Emprint microwave generator and the Medtronic lung navigation platform to offer a minimally invasive, localized treatment of malignant lesions in the lung, according to a news […]
