Inspire Medical Systems (NYSE:INSP) announced today that the FDA approved an expanded indication for its sleep apnea therapy. Minneapolis-based Inspire develops minimally invasive solutions for patients with obstructive sleep apnea (OSA). The proprietary Inspire therapy is the first and only FDA-approved neurostimulation technology that treats moderate to severe OSA. It offers an alternative to traditional […]
Neuromodulation/Neurostimulation
Precision Neuroscience begins first-in-human trial for brain-computer interface
Precision Neuroscience today announced the completion of the first-in-human procedures for a pilot clinical study of its neural implant system. The study evaluates the company’s brain-computer interface (BCI), the Layer 7 Cortical Interface. Precision Neuroscience designed the Layer 7 with 1,024 tiny electrodes spanning an area of one square centimeter. The company embedded the electrodes […]
FDA approves Zoll therapy for sleep apnea with MRI
Zoll Medical announced that it received FDA approval for its Remedē system for conditional use with magnetic resonance imaging (MRI). Chelmsford, Massachusetts-based Zoll designed its Remedē system as an implantable, transvenous phrenic nerve stimulation therapy. It treats adults with moderate to severe central sleep apnea (CSA). Full-body MRI approval applies to all models of the […]
Research supports brain-computer interface tech from Onward
Onward Medical announced today that published data demonstrates the ability of its wireless brain-computer interface (BCI). The data, published in Nature, demonstrates how the BCI uses thought to modulate ARC therapy. Researchers say that, when paired with ARC therapy, an implanted BCI allowed an individual to gain augmented control over when and how he moved […]
Cala Health, Cue Health have layoffs in California
Cala Health and Cue Health (Nasdaq:HLTH) both recently filed with the state of California to confirm reductions in their workforces. The two companies are the latest to join the long list of medtech companies cutting employees amid a challenging time for the industry. To date, MassDevice has reported on more than 18,000 medtech employees who have been […]
Cadence Neuroscience raises $26M to support epilepsy neuromod therapy
Neurmodulation technology developer Cadence Neuroscience announced that it secured $26 million in a Series B financing round. The Angelini Lumira Biosciences Fund led the round. It also included new investors F-Prime Capital, LivaNova USA, Angelini Ventures, Spectrum Financial Services and Mayo Clinic. Series A lead investor, Jazz Venture Partners, also contributed. In connection with the […]
Paradromics raises $33M, wins FDA breakthrough nod for brain-computer interface tech
Paradromics announced today that it raised $33 million in a Series A funding round and garnered an FDA breakthrough device designation. Austin, Texas-based Paradromics develops a high data-rate brain-computer interface (BCI). The company sees its latest financial and regulatory progress as a positive step into the competitive BCI market. Paradromics plans to use the funding […]
First clinical case performed with NeuroOne Evo sEEG, Zimmer Biomet Rosa One Brain
NeuroOne Medical Technologies (Nasdaq:NMTC) today announced the first clinical case performed with its Evo sEEG in robotic neurosurgery. Dr. William Bingaman performed the procedure with the electrode — exclusively marketed by Zimmer Biomet — at Cleveland Clinic. It marks the first procedure to utilize NeuroOne’s Evo sEEG with Zimmer Biomet’s Rosa One Brain. The Rosa […]
FDA approves Abbott spinal cord stimulation devices for non-surgical back pain
Abbott (NYSE:ABT) announced today that it received FDA approval for the use of its spinal cord stimulation devices (SCS) for certain people with back pain. The FDA approval applies to the treatment of chronic back pain in those who have not had or are not eligible to receive back surgery. This is also known as […]
Onward completes first-in-human use of movement-restoring lead
Onward Medical announced today that it successfully completed the first-in-human use of its investigational ARC-IM lead. Eindhoven, the Netherlands-based Onward designed the lead to restore movement, function and independence in people with spinal cord injury (SCI). The company developed ARC-IM to deliver targeted electrical pulses to the spinal cord. It represents a key component of […]
BrainsWay launches study program to evaluate neurostim tech
BrainsWay (Nasdaq:BWAY) announced today that it launched an investigator-initiated study (IIS) program for its Deep TMS technology. The company designed the program to support further research for Deep TMS (transcranial magnetic stimulation) by the clinical research community. According to a news release, BrainsWay plans to utilize data collaboration and equipment loan initiatives. The company accepts […]
