Biorez announced that it received FDA 510(k) clearance for two sizes of its BioBrace implant for tendon and ligament procedures. New Haven, Conn.-based Biorez designed its biocomposite soft tissue scaffold for use in a range of surgical procedures to reinforce soft tissue where weakness exists, according to a news release. The implant can be used […]
FDA
CMS delays Medicare payments for breakthrough devices until December
Medicare coverage for FDA-designated breakthrough medical devices will have to wait several more months, despite broad support. The Centers for Medicare and Medicaid Services (CMS) issued a final rule on Medicare Coverage of Innovative Technology (MCIT) in January, granting coverage for breakthrough devices the same day as their FDA approvals, for up to four years. Immediately […]
This imaging device could be a breast cancer treatment breakthrough
OncoRes Medical’s system may detect cancer cells on a microscopic scale during a lumpectomy, potentially averting the need for a second breast cancer surgery. Having breast surgery to remove a cancerous lump is traumatic enough. Learning that you’ll need another operation to remove cancer cells that the surgeon couldn’t detect the first time only adds […]
FDA warns about consumer electronics and implanted devices
The FDA is advising the public that certain consumer devices have high-field strength-magnets that can send medical devices into “magnet mode.” Magnets of this nature can affect the normal operations of implanted medical devices until the magnetic field is moved, according to the FDA news release. Get the full story at our sister site, Medical […]
Abbott recalls pacemakers that may short circuit
Abbott is recalling certain pacemakers that may short circuit because they can allow moisture inside, according to the FDA. The recall covers 61,973 Assurity and Endurity pacemakers manufactured by St. Jude Medical and distributed from April 2015 to February 2019. (Abbott acquired St. Jude in 2017). A small number of devices from that time frame […]
Bose jumps into hearing aid market
Bose just introduced FDA-cleared, direct-to-consumer hearing aids for adults with mild to moderate hearing loss. Users can use a smartphone app to fit, program and control a SoundControl hearing aid without a doctor visit, hearing test or prescription, according to Framingham, Mass.-based Bose. Each hearing aid will retail for $849.95 starting May 18th in five […]
Medtronic HeartWare instructions recall is serious
Medtronic (NYSE:MDT) is recalling its HeartWare instructions for use and patient manual due to risks from dropping the case, incorrect installation and misinterpretation of an alarm signal. FDA today designated the recall as Class I, its most serious level of recall. The HeartWare ventricular assist device (HVAD) is used as a bridge to heart transplants in […]
FDA approves J&J Vision’s overnight contact lens for myopia management
Johnson & Johnson Vision announced today that it received FDA approval for its Acuvue Abiliti overnight therapeutic lenses. Jacksonville, Fla.-based J&J Vision touts the Acuvue Abiliti as the first and only FDA-approved orthokeratology (ortho-k) contact lens for managing myopia, according to a news release. The company designed the Abiliti overnight ortho-k lenses to be fitted […]
Avenda Health wins FDA breakthrough nod for AI-based prostate cancer treatment
Avenda Health announced today that it received FDA breakthrough device designation for its AI-based male “lumpectomy” product. Santa Monica. Calif.-based Avenda designed its lumpectomy product to treat prostate cancer in-office while preserving the quality of life through AI and minimally invasive technologies, according to a news release. The Avenda Health focal therapy system spares healthy […]
Think Surgical robot can use Ortho Development implants, FDA says
The FDA has cleared two Ortho Development knee implants for use with a Think Surgical robotic system, the companies announced today. Surgeons will now be able to use Ortho Development’s Balanced Knee system (BKS) and BKS TriMax implants with Think Surgical’s TSolution One total knee arthroplasty system. TSolution One is the only commercially available active robot system for total […]
FDA OKs Pfizer-BioNTech COVID-19 vaccine for younger adolescents
The FDA has authorized the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) for adolescents as young as 12. The agency had previously authorized the vaccine for people 16 and older in December 2020. The FDA came to its decision after Pfizer demonstrated in a Phase 3 trial that the vaccine showed 100% efficacy in preventing symptomatic […]
