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 […]
Neuromodulation/Neurostimulation
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. […]
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 […]
Neuromod startup IVEAcare raises $27.5M, names CEO
Minneapolis-based neuromodulation technology developer iVEAcare announced today that it raised $27.5 million in a Series A financing round. iVEAcare spun out from NuXcel, a medical device accelerator. It seeks to develop and commercialize next-generation neuromodulation technologies to treat chronic diseases. The company also named Todd Kerkow as its new president and CEO. A medical device […]
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 […]
AtriCure launches new cryoablation probe
AtriCure announced today that it launched its new CryoSphere+ cryoablation probe for the CryoIce platform. CryoSphere+ leverages new insulation technology, reducing freeze times by 25% compared to the legacy CryoSphere device. The original CryoIce device first received FDA clearance in November 2018 and aided in more than 60,000 procedures to date. The CryoSphere+ device picked […]
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 […]
Cognito Therapeutics has positive non-invasive neuromod results
Cognito Therapeutics today announced treatment results from an open-label extension study of its Alzheimer’s treating neuromodulation system. The Cambridge, Massachusetts-based company’s Spectris system could provide disease-modifying therapy for treating Alzheimer’s disease. Its non-invasive neuromodulation device delivers proprietary gamma frequency light and sound stimulation. This evokes EEG-confirmed gamma frequency brain oscillations to treat central nervous system […]
NeuroOne implants first OneRF ablation electrode
NeuroOne Medical Technologies (Nasdaq:NMTC) today announced the first implant of its OneRF Ablation electrode. The OneRF Ablation system is FDA 510(k) cleared to create radiofrequency nervous tissue lesions for functional neurosurgical procedures. The electrodes are a thin-film, sEEG-guided RF system that records the electrical activity and ablates nervous tissue with the added benefit of temperature control. […]
Neurovalens wins FDA nod for anxiety-treating neuromod device, raises $2.65M
Neurovalens announced today that it received FDA clearance for its Modius Stress device for treating anxiety and raised $2.65 million. Belfast, Northern Ireland–based Neurovalens designed Modius Stress to deliver non-invasive electrical stimulation. It stimulates key areas of the brain and nervous system without the need for surgically implanted electrodes. Modius Stress treats anxiety with a […]
FTC wants more info on Boston Scientific, Axonics deal with closing timeline pushed back
Boston Scientific said today that the FTC requested additional information regarding its planned $3.7 billion acquisition of Axonics (Nasdaq:AXNX). In an SEC filing, Boston Scientific said both it and Axonics received requests from the FTC (U.S. Federal Trade Commission). The agency seeks to gather more information in connection with its review of the merger. Reports […]