Medtronic (NYSE:MDT) announced today that it received FDA approval for its SenSight directional lead system used in deep brain stimulation therapy. Fridley, Minn.–based Medtronic designed the SenSight directional lead system for DBS therapy to combine directionality and sensing to allow physicians to deliver precise, patient-specific DBS therapy for treating some symptoms associated with movement disorders […]
Implants
Philips touts 2-year data for Tack endovascular system
Royal Philips (NYSE:PHG) today announced positive two-year results from a clinical trial of the Tack endovascular system. Amsterdam-based Philips presented data from the Tack Optimized Balloon Angioplasty (TOBA) II below-the-knee (BTK) clinical trial at the 2021 New Cardiovascular Horizons Conference, according to a news release. Data presented by co-principal investigator Dr. George Adams, an interventional […]
FDA clears ChoiceSpine’s Blackhawk Ti cervical spacer system
ChoiceSpine announced today that it received FDA clearance for its Blackhawk Ti cervical spacer system. Knoxville, Tenn.-based ChoiceSpine designed its Blackhawk Ti cervical spacer system with the BioBond 3D-printed titanium porous matrix and a large open graft window for bone graft containment and maximum visualization, according to a news release. Additionally, the platform consists of […]
Feds want more input on materials with ‘high-profile safety concerns’
The FDA today asked the public to submit comments on how devices that contain certain materials should be labeled. The materials are ones to which patients have long-term exposure — contact time exceeding 30 days — and that have presented “high-profile safety concerns,” according to the agency. They include female sterilization devices, metal-on-metal hips and […]
FDA leapfrogs guidance on brain-computer interface devices
The FDA today issued leapfrog guidance for nonclinical testing and study design related to implanted brain-computer interface (BCI) devices. Leapfrog guidance allows the agency to share its initial thoughts on emerging technologies that are early in development but appear likely to be of importance to public health, according to a Federal Register notice. The guidance offered […]
Intersect ENT wins CE mark for Propel Contour sinus implant
Intersect ENT (NSDQ:XENT) announced today that it received CE mark approval for its Propel Contour sinus implant. Menlo Park, Calif.-based Intersect ENT designed its Propel Contour sinus implant to maintain patency and reduce inflammation while conforming to the sinus ostia (openings) through mechanical support and steroid delivery where needed to optimize sinus surgery outcomes. Propel […]
FDA clears Biorez BioBrace implant technology
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 […]
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 […]
