Startup SetPoint Medical has raised $15.7 million of a total $20.5 million it is seeking in a new funding round, according to a regulatory filing. The Valencia, Calif.-based company will use the money to help it prepare for a pivotal clinical trial of its implantable bioelectronic device intended to treat rheumatoid arthritis (RA), according to […]
Neuromodulation/Neurostimulation
Saluda Medical wins CE Mark for Evoke closed-loop SCS
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 […]
BioSig’s NeuroClear Technologies raises nearly $4m
BioSig Technologies (NSDQ:BSGM) said last week that its subsidiary, NeuroClear Technologies, raised nearly $4 million in an initial seed-funding round. NeuroClear said it intends to use the proceeds from the $3.7 million round to fund product development and initial pre-clinical studies, development of its intellectual property portfolio and for general corporate purposes. Founded in November 2018, […]
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 […]
Former NFL player may pursue pain pump lawsuit against Stryker, I-Flow
A former NFL player may proceed with a federal lawsuit against Stryker (NYSE:SYK) and I-Flow over a pain pump that the player claims destroyed the cartilage in his shoulder. U.S. District Court Judge Gloria Navarro ruled last week that former New England Patriots linebacker Ryan Claridge could add specifics to his claim that Stryker and […]
Flowonix warns on software anomaly with Prometra pump
Flowonix earlier this month warned about a software anomaly with its Prometra infusion pump that could unexpectedly shut down the device. The Budd Lake, N.J.-based company won FDA approval in February for updated software included in the Prometra system, which is indicated for intrathecal infusion of drug therapy, including infumorph, saline and baclofen. Flowonix warned […]
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 […]