Cook Medical announced today that the U.S. Dept. of Defense (DOD) awarded it an ECAT contract for implantable medical devices. The contract includes implantable vascular medical devices like the Zilver PTX drug-eluting peripheral stent. It also applies to the Zenith aortic endografts and associated interventional devices for treating vascular disease. Cook Medical said in a […]
Implants
OM1, Medtronic partner on drug-eluting implant study
OM1 today announced positive results from its partnership with Medtronic (NYSE:MDT) evaluating the Propel corticosteroid-eluting implants. The Propel bioabsorbable implant family came to Medtronic through its acquisition of IntersectENT in 2022. OM1 and Medtronic partnered on their study to focus on healthcare resource use and long-term outcomes in patients with chronic rhinosinusitis (CRS) who underwent […]
J&J’s DePuy Synthes launches new spine screw system
Johnson & Johnson’s DePuy Synthes orthopedic unit today announced plans to showcase new advancements across its spine portfolio. The company plans to show the offerings at the 31st International Meeting on Advance Spine Techniques (IMAST) 2024 this week. Notably, the company plans to unveil its next-generation TriAltis spine system. The posterior thoracolumbar pedicle screw system […]
Orthobond wins FDA de novo approval for antibacterial technology that could have vast device applications
Orthobond has secured FDA de novo approval for its Ostaguard antibacterial technology that could one day be used for a wide range of medical devices — and beyond medtech. The Monmouth Junction, New Jersey-based device developer says it’s the first time the FDA has granted a de novo request for a non-eluting coating designed to […]
Synchron launches BCI registry with eyes on larger study, approval
Synchron announced today that it launched a community-centered registry to evaluate its brain-computer interface (BCI) technology. The company said its study aims to bring patients, carers and clinicians together to learn about BCI design and its benefits for people with limited mobility. Synchron designed its BCI technology to decipher the neural code of the brain, […]
Onward submits movement-restoring spinal cord stim tech to FDA
Onward Medical announced today that it submitted a de novo application to the FDA for the approval of its ARC-EX spinal cord stimulation system. The Eindhoven, the Netherlands-based company designed ARC-EX to restore function of upper extremities after spinal cord injury (SCI). If approved, the company says ARC-EX would become the first ever SCS therapy […]
Neuralink may be getting some scrutiny on Capitol Hill
Reuters reports that U.S. Rep. Earl Blumenauer (D-OR) issued a letter to the FDA questioning its inspection practices related to Neuralink. The report said Blumenauer asked why the FDA decided not to investigate the Elon Musk-backed brain chip maker before allowing in-human trials. This relates to repeated questions around animal practices at the company. Reuters […]
FDA approves next-gen Evolut TAVR system from Medtronic
Medtronic announced today that the FDA approved its next-generation Evolut FX+ transcatheter aortic valve replacement (TAVR) system. The FDA’s approval covers the treatment of symptomatic aortic stenosis. Medtronic says the latest version of the Evolut valve maintains the performance of the Evolut platform with a design that facilitates coronary access. Evolut FX+ TAVR offers larger […]
Stryker launches hip fracture nailing system in Europe
Stryker announced today that it launched its Gamma4 hip fracture nailing system across most European markets. Gamma4, the newest Gamma system, offers the next generation of Stryker’s intramedullary nailing system. The company designed Gamma4 to treat hip and femur fractures and streamline procedural workflows for surgeons. It received CE mark in September 2023 and Stryker […]
NeuroOne begins neuroablation system launch in U.S.
NeuroOne Medical Technologies (Nasdaq:NMTC) announced today that it initiated a limited commercial launch for its OneRF ablation system. The Eden Prairie, Minnesota–based company said its initial rollout comes earlier than it previously expected. It picked up FDA 510(k) clearance for the OneRF system just over three months ago in December 2023. Indications cover the creation […]
Precision Neuroscience launches new BCI study sites
Precision Neuroscience announced that it launched new clinical study sites at Mount Sinai Health System and the University of Pennsylvania. The company says the studies represent “a major step forward” as it aims to understand how the brain controls movement. It hopes to utilize the sites to advance its brain-computer interface (BCI) technology for people […]