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 […]
Implants
5 of the latest cardiac tech insights out of ACC.21
The American College of Cardiology’s 70th Annual Scientific Session has produced some positive news about some controversial cardiac tech. Drug-coated stents, which a 2018 study linked to late-stage death, were shown to be non-inferior to non-drug-coated stents in patients with peripheral arterial disease. And a new study of renal denervation that used a different methodology […]
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 […]
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 […]
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 […]
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 […]
CMS extends joint replacement pricing by 3 years
The Centers for Medicare and Medicaid Services (CMS) has extended bundled pricing for hip and knee replacements for three years. The final rule, published in the Federal Register, extends the “Comprehensive Care for Joint Replacement” cost-bundling program through Dec. 21, 2024. The cost-cutting program began in January 2016, when CMS required all hospitals in 67 geographic […]
Butterfly Network partners with Sientra on ultrasound for breast implant patients
Butterfly Network (NYSE:BFLY) and Sientra (NSDQ:SIEN) announced today that they are partnering to aid plastic surgeons in breast implant evaluations. Through the partnership, plastic surgeons can use Butterfly Network’s Butterfly IQ and Ultrasound-on-Chip technology to evaluate Santa Barbara, Calif.–based Sientra’s breast implants, according to a news release. Guilford, Conn.–based Butterfly Network’s Butterfly IQ handheld ultrasound […]
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 […]
Delpor doses first patient in once-yearly risperidone implant trial
Delpor announced today that it dosed the first patient in a Phase 1b/2a clinical trial for its DLP-114 risperidone implant. DLP-114 is a long-acting formulation of the antipsychotic risperidone for schizophrenia maintenance therapy. The open-label study is to evaluate the safety, tolerability and pharmacokinetics of switching from oral risperidone to the once- or twice-yearly DLP-114 risperidone […]
UC Berkeley researchers tout tiny sensor that can detect tissue oxygen levels
Engineers at the University of California, Berkeley, are touting an implant that can provide real-time measurements of tissue oxygen levels. The tiny wireless device is smaller than a ladybug and powered by ultrasound waves to help monitor the health of transplanted organs or tissue through real-time measurements of oxygen levels in tissues deep beneath the […]