Medtronic announced today that it received FDA approval for the Inceptiv closed-loop rechargeable spinal cord stimulator (SCS) system. Inceptiv treats chronic pain and represents Medtronic’s first SCS device to offer a closed-loop feature. This feature senses each person’s unique biological signals, adjusting stimulation moment-to-moment as needed. Medtronic says that keeps therapy in harmony with the […]
Implants
BCI maker Science acquires retinal implant from Pixium Vision
Brain-computer interface developer Science Corporation announced today that it acquired the IP and related assets for the Pixium Vision Prima implant. Neuralink co-founder Max Hodak founded Science, which unveiled its Science Eye brain-computer platform in 2022. The Science Eye is a visual prosthesis. It targets retinitis pigmentosa (RP) and dry age-related macular degeneration (AMD), two […]
Boston Scientific warns on some Vercise Genus implantable pulse generators
Boston Scientific recently issued an urgent field safety notice for certain Vercise Genus deep brain stimulation (DBS) implantable pulse generators. In the urgent field safety notice released in the United Kingdom, the company warned about the potential for Vercise Genus DBS IPG stimulation therapy to be transiently suspended during charging due to a device reset. […]
Blue Arbor wins FDA breakthrough nod for neuromuscular interface
Blue Arbor Technologies announced today that it received FDA breakthrough device designation for its Restore neuromuscular interface system. The FDA also accepted the system into its Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot. TAP provides early and frequent strategic engagement from the FDA, patients, providers and payers. It facilitates rapid development and widespread […]
Neuronoff hits first-in-human milestone for Injectrode neuromod
Neuronoff announced today that it completed the first-in-human clinical trial evaluating its flagship Injectrode neuromodulation product. The Cleveland-based company designed Injectrode to treat chronic pain. The LIFE (lumbar Injectrode feasibility evaluation) trial evaluated Injectrode’s safety and effectiveness, meeting all goals, the company said. Injectrode placement comes through an 18-gauge needle (no incisions) under local analgesia […]
Medtronic launches next-gen surgical aortic tissue valve
Medtronic today announced the launch of its next-generation Avalus Ultra surgical aortic tissue valve. The medtech giant designed the valve to facilitate ease of use at implant and lifetime patient management. It offers clear visibility for future valve-in-valve procedures and straightforward sizing. Other features of Avalus Ultra include a low profile and a polyetheretherketone (PEEK) […]
Hyalex Orthopaedics announces first cases with synthetic knee cartilage implant
Hyalex Orthopaedics announced today that patients successfully received knee implants as part of its first-in-human clinical trials. The procedures came as part of two prospective, studies for the Hyalex Knee Cartilage System in the U.S. and Europe. Sites for both studies already enrolled and treated patients with the synthetic cartilage technology. The technology has FDA […]
CroíValve is set to challenge as tricuspid regurgitation treatment space heats up
With Edwards and Abbott making recent waves in the tricuspid regurgitation (TR) treatment space, CroíValve hopes to pave its own way. Edwards’ Evoque valve became the first transcatheter therapy to receive FDA approval to treat TR in February. This month, Abbott became the second with its TriClip transcatheter edge-to-edge repair (TEER) system picking up an […]
10 new, innovative medical devices to watch for in 2024
By Senior Editor Danielle Kirsh and Associate Editor Sean Whooley Significant medical device launches are coming in 2024. Think pulsed field ablation, diabetes treatment tech, surgical robotics and more. Pulsed field ablation news took over at the end of 2023 and the start of 2024, with Medtronic and Boston Scientific garnering significant regulatory approvals. Surgical […]
CVRx has more data supporting long-term benefits of Barostim
CVRx (Nasdaq:CVRX) announced the publication of post-market data highlighting long-term, sustained benefits with its Barostim device. Minneapolis-based CVRx published results from the BeAT-HF trial in the European Journal of Heart Failure. Data supported Barostim treatment in heart failure patients with reduced ejection fraction. Barostim delivers electrical pulses to baroreceptors in the wall of the carotid […]
Glucotrack expands CGM tech to spinal epidural space
Glucotrack (Nasdaq:GCTK) announced today that it plans to expand its glucose monitoring technology to measure glucose in the epidural space. Rutherford, New Jersey-based Glucotrack said CGM taking readings in the spinal epidural space could integrate with existing treatments for painful diabetic neuropathy (PDN). Specifically, Glucotrack sees spinal cord stimulation (SCS) technology as a potential integration […]