CMS intends to kill the Medicare Coverage of Innovative Technology (MCIT) program that would have accelerated government payments for medical devices designated by the FDA as breakthroughs. CMS (the U.S. Centers for Medicare & Medicaid Services) disclosed its proposal in the Federal Registrar yesterday — three months before the rule was set to take effect […]
Food & Drug Administration (FDA)
Smiths Medical has a Class I recall over aluminum potentially leaking in fluid warmers
Smiths Medical is recalling half a million Normoflo irrigation fluid warmers and warmer sets due to the potential for aluminum ions to leach into warmed fluids. The recall has been designated as a Class I recall — the most serious kind — by the FDA. According to an FDA notice, when fluid circulates through a […]
COVID-19 vaccine booster tensions mount between White House, CDC and FDA
Facing the second-biggest wave of COVID-19 infections and waning popularity, President Biden has promised to launch an initiative to begin providing vaccine boosters starting September 20. But the plan hinges upon FDA and CDC support, and some officials at the agencies remain unconvinced that boosters are immediately necessary. Two departing senior FDA vaccine officials recently co-wrote […]
InTRAvent wins FDA 510(k) clearance for Solopass bedside neuro-navigation device
InTRAvent has announced FDA 510(k) clearance of its Solopass system for assisting frontal placement of intraventricular catheters deep within the brain. The Hershey, Pennsylvania-based company said yesterday that it designed the device with 2D and 3D ultrasound imaging, artificial intelligence and trajectory guidance for intraprocedural localization and navigation for external ventricular drain (EVD) placement. Get […]
Cepheid wins EUA for new version of COVID-19, flu, RSV combination diagnostic
Cepheid announced today that it received FDA emergency use authorization (EUA) for its Xpert Xpress CoV-2/Flu/RSV Plus diagnostic. Sunnyvale, California-based Cepheid designed its Xpert Xpress Plus as a rapid molecular diagnostic test for the qualitative detection of the viruses causing COVID-19, Flu A, Flu B and respiratory syncytial virus (RSV). Nearly one year ago, the […]
FDA clears NeuroOne’s Evo sEEG electrode
NeuroOne Medical Technologies (NMTC) announced that it received FDA 510(k) clearance for its Evo sEEG electrode technology. Eden Prairie, Minnesota-based NeuroOne’s Evo sEEG electrode technology received clearance for temporary (less than 24 hours) recording, monitoring and stimulation of electrical signals at the subsurface level of the brain, according to a news release. The Evo sEEG […]
Novocure wins FDA breakthough designation for liver tumor treatment device
Novocure (NSDQ:NVCR) announced today that the FDA granted breakthrough designation for its NovoTTF-200T liver cancer treatment system. St. Helier, Jersey-based Novocure designed its NovoTTF-200T system, a tumor treating fields (TTFields) delivery system for use in tandem with atezolizumab and bevacizumab for the first-line treatment of patients with unresectable or metastatic liver cancer. According to a […]
Report: Congressional committees have questions over Biogen’s Alzheimer’s drug
The FDA’s relationship with Biogen is under scrutiny following the controversial approval granted to the company’s Aduhelm Alzheimer’s drug. According to a report from Endpoints News, the House Energy & Commerce and Oversight committee chairs issued a letter this week requesting that acting FDA Commissioner Dr. Janet Woodcock and the FDA provide very specific information by Sept. 16, […]
FDA approves TransMedics’ OCS Heart system
TransMedics (NSDQ:TMDX) announced today that it received FDA premarket approval for its OCS Heart system. Andover, Massachusetts-based TransMedics designed its OCS Heart system for use with organs from donors after brain death with indication for preserving donor hearts deemed unsuitable for procurement and transplantation at initial evaluation due to limitations of prolonged cold static cardioplegic […]
FDA approves Impel NeuroPharma’s nasal spray for treating migraines
Impel NeuroPharma (NSDQ:IMPL) announced today that the FDA approved its Trudhesa nasal spray for treating migraine in adults. Seattle-based Impel NeuroPharma plans to launch Trudhesa commercially early next month. The company’s shares took a massive hit, though, dropping -19.3% at $18.65 per share by market close and continuing to slide down -0.8% at $18.50 after hours […]
Glaukos submits supplemental PMA application for iStent Infinite
Glaukos (NYSE:GKOS) announced today that it submitted a supplemental premarket approval application to the FDA for its iStent Infinite system. San Clemente, California–based Glaukos designed the iStent Infinite trabecular micro-bypass system for use in a standalone procedure to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma uncontrolled by prior surgery or medical therapy. Get […]
