Saluda Medical said today that it won CE Mark approval in the European Union for its Evoke closed-loop spinal cord stimulation device. Australia- and Bloomington, Minn.-based Saluda, which is backed by both Boston Scientific and Medtronic, said the first commercial implantations have already occurred, in Holland. The Evoke device is designed to measure the response […]
Functional Neuromodulation launches Alzheimer’s DBS trial
Functional Neuromodulation said yesterday that it has begun a pivotal clinical trial to assess deep brain stimulation (DBS) in patients with mild Alzheimer’s disease. The Minneapolis-based company said the study will evaluate the safety and efficacy of stimulating the fornix (DBS-f) — a major inflow and output pathway in the brain’s memory circuit. Research suggests […]
FDA approves Axonics sacral neuromod for FI
Axonics Modulation Technologies (NSDQ:AXNX) today said it received FDA approval for its rechargeable sacral neuromodulation device. The rechargeable SNM device is designed to treat urinary and bowel dysfunction in adults and features a neurostimulator about the size of a USB drive that lasts 15 years in the body. Irvine, Calif.-based Axonics also has a pre-market approval […]
LivaNova wins Medicare nod for nerve stimulation trial
Medicare has approved a LivaNova (NSDQ:LIVN) study of vagus nerve stimulation (VNS) to treat depression, the company said today. The Centers for Medicare and Medicaid Services accepted the London-based company’s protocol for a clinical trial to study the safety and effectiveness of adding VNS to traditional depression treatment in patients with treatment-resistant depression. Approval of […]
Orchestra BioMed wins CE Mark for BackBeat hypertension neurostim, names CMO
Orchestra BioMed said yesterday that it received the CE Mark for its Moderato implantable pulse generator system for BackBeat cardiac neuromodulation therapy (CNT), just nine days after naming a new chief medical officer. BackBeat therapy is a bioelectronic treatment designed to lower blood pressure while modulating the autonomic nervous system. The Moderato implantable device is […]
Inspire Medical adds more LCDs
Inspire Medical Systems (NYSE:INSP) yesterday said, for the second time this week, that two local coverage determination drafts were published for coverage of its sleep apnea therapy. Inspire Medical had two LCDs published August 26 by Medicare contractors Noridian Medicare and Palmetto GBA. Yesterday the Minneapolis-based company said Novitas Solutions and First Coast Service Options also […]
Inspire Medical Systems touts reimbursement wins
Inspire Medical Systems (NYSE:INSP) said two local coverage determination drafts were published to propose coverage of its sleep apnea therapy system. Minneapolis-based Inspire’s sleep apnea device uses hypoglossal nerve stimulation to treat obstructive sleep apnea. The two LCDs will be issued by Noridian Medicare and Palmetto GBA. The two companies collectively represent 19 states. According […]
Boston Scientific wins FDA nod for MR-safe Vercise Gevia DBS
Boston Scientific (NYSE:BSX) said yesterday that it won FDA approval for MR-conditional labeling on its Vercise Gevia deep-brain stimulation device for treating Parkinson’s disease. The ImageReady MRI label means the device and its companion Vercise Cartesia directional lead can be used during 1.5-Tesla full-body MRI scans, the Marlborough, Mass.-based company said. “Boston Scientific continually strives to […]
Study shows bioelectronic medicine reduces spasticity in stroke patients
A clinical trial of an investigational, non-invasive medical device has shown that trans-spinal direct-current stimulation and peripheral nerve direct-current stimulation significantly reduced upper-limb spasticity in participants who had experienced a stroke. The treatment involves passing a direct electrical current across the spinal cord with a skin-surface electrode, known as trans-spinal direct-current stimulation (tsDCS), and adding […]
Nevro beats the Street with Q2 results
Shares in Nevro (NYSE:NVRO) rose this week after the medical device maker topped expectations on Wall Street with its second-quarter financial results. The Redwood City, Calif.-based company posted a net loss of -$28 million on sales of $93.6 million for the three months ended June 30. Compared with the same period last year, Nevro’s revenue fell […]
Second Sight beat The Street in Q2 despite $8.44m loss
Second Sight Medical (NSDQ:EYES) posted second-quarter results yesterday that beat both the sales and earnings forecasts on Wall Street as it accelerated its pivot toward manufacturing a new cortical implant. Citing the costs of reorganization, the Sylmar, Calif.-based company reported a loss of $8.44 million, or -0.07¢ per share, on sales of $1.28 million for […]
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