Onkos Surgical today announced that it received FDA 510(k) clearance for its BioGrip 3D-printed implant technology. The Parsippany, N.J.–based company designed BioGrip to address the clinical challenge of aseptic loosening in musculoskeletal oncology and complex orthopedic limb salvage surgery. It helps provide bone ingrowth at the bone-implant interface. Get the full story on our sister […]
Implants
Glaukos wins Australian regulatory approval for MicroShunt
Glaukos (NYSE:GKOS) recently announced that it received regulatory approval from Australia’s Therapeutic Goods Administration for its Preserflo MicroShunt. The San Clemente, Calif.–based company designed the MicroShunt to reduce intraocular pressure in the eyes of patients who have primary open-angle glaucoma where IOP remains uncontrollable or where glaucoma progression needs surgery. Get the full story on our […]
Glaukos completes enrollment in Phase 3 trials for iDose TR drug-eluting implant
Glaukos (NYSE:GKOS) announced today that it completed enrollment for a Phase 3 clinical program for its iDose TR sustained-release travoprost implant. San Clemente, Calif.–based Glaukos’ iDose TR implant contains a novel formulation of travoprost, a prostaglandin analog used to reduce intraocular pressure (IOP) through a design that continuously releases therapeutic levels of the medication for […]
FDA approves Medtronic’s SenSight directional lead system for DBS therapy
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 […]
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 […]
