ClearPoint Neuro (NSDQ:CLPT) announced an agreement with Blackrock Neurotech to develop automated technologies for brain implant surgeries. The partnership will seek to develop an automated surgical solution for implanting brain-computer interfaces (BCIs) into patients with neurological disorders including from paralysis, ALS, blindness and hearing loss, among others. Get the full story at our sister site, […]
Implants
The 18 most innovative medical devices of 2021
The Galien Foundation today announced the nominees for most innovative medical devices for its 15th annual Prix Galien USA Awards. The foundation nominates devices, biotechnology and pharmaceutical products for its annual Prix Galien awards to highlight products designed to improve the human condition. “The Awards Committee is excited to introduce the nominees for the 2021 […]
FDA raises concerns about NuVasive Magec devices
The FDA today issued a notice warning patients, caregivers and healthcare providers of potential issues with Magec devices from NuVasive (NSDQ:NUVA). NuVasive’s Magec, a growing spinal rod system intended for use in children under 10, uses magnets to help correct spinal deformities as the child grows. The company designed Magec to help avoid multiple operations while […]
FDA grants iStar Medical IDE for glaucoma implant pivotal trial
iSTAR Medical announced today that the FDA granted investigational device exemption to start a pivotal trial with its MINIject implant. Wavre, Belgium–based iStar’s MINIject minimally invasive implant for glaucoma surgery will be investigated in the STAR-V study, which will enroll over 350 patients with primary open-angle glaucoma. Get the full story at our sister site, Drug […]
Stryker launches humeral system as part of new portfolio
Stryker (NYSE:SYK) announced today that it launched the Perform humeral stem as part of its newly introduced Tornier shoulder arthroplasty portfolio. Kalamazoo, Mich.-based Stryker designed its Tornier Perform humeral stem for use in anatomic, reverse and hemiarthroplasty of the shoulder to allow for conversion from an anatomic to a reverse shoulder prosthesis in the case […]
FDA warns of biocompatibility concerns with NuVasive’s Precise devices
The FDA today informed healthcare providers of potential biocompatibility concerns with Precice devices from NuVasive (NSDQ:NUVA). Precice devices are implants for those 18 years of age and older and are used to lengthen the limb, shorten or compress the limb or transport segments of long bones. They include adjustable rods that are placed inside a […]
Conformis, Stryker settle in Wright Medical patent infringement litigation
Conformis (NSDQ:CFMS) announced today that it settled with Stryker (NYSE:SYK) to resolve patent litigation involving Wright Medical. Billerica, Mass.based Conformis said in a news release and SEC filing that Stryker — which acquired Wright Medical in November 2020 — will make a one-time $15 million payment to Conformis. Stryker in return will receive a non-exclusive license […]
Orthofix announces U.S. launch, first patient implant of 3D-printed spacer system
Orthofix (NSDQ:OFIX) announced today that it launched and implanted the first 3D-printed Forza Ti PLIF spacer system in the U.S. Lewisville, Texas-based Orthofix’s 3D-printed Forza Ti posterior lumbar interbody fusion (PLIF) spacer system uses the company’s Nanovate technology to comprise a titanium lumbar interbody device that allows the bone to grow into and through the […]
Axonics files FDA PMA supplement for its non-rechargeable SNM system
Axonics (NSDQ:AXNX) announced that it filed a premarket approval supplement with the FDA for its sacral neuromodulation (SNM) system. Irvine, Calif.-based Axonics filed the PMA supplement for its newly developed, long-lived, non-rechargeable SNM implantable neurostimulator (INS), according to a news release. The company designed its new non-rechargeable SNM system to replicate the key features of […]
Onkos Surgical wins FDA clearance for BioGrip 3D-printed implant
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 […]
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 […]