NeuroPace announced today that FDA approval of MRI labeling for its RNS system for people living with seizures that do not respond to medication. The Mountain View, Calif.–based company touts its RNS system as the world’s only closed-loop brain-responsive neurostimulation system designed to prevent seizures at their source. It includes a neurostimulator, leads placed at […]
Neuromodulation/Neurostimulation
Neuronetics president and CEO stepping down
Neuronetics (NSDQ:STIM) recently announced that president and CEO Christopher Thatcher would be stepping down, effective immediately. Thatcher also resigned as director of the board of directors and his employment is expected through May 1. He will continue to provide transition services and advice to the company. Neuronetics said that Thatcher’s resignation was a mutual agreement and […]
NeuroMetrix settles $4m false advertising case with FTC
Pain-treating TENS device company NeuroMetrix (NSDQ:NURO) has agreed to pay at least $4 million to settle a false advertising case brought by the Federal Trade Commission FTC. The commission said today that the Woburn, Mass.-based company also agreed to stop making deceptive claims that its Quell device treats pain throughout the body when placed below the […]
Neuronetics stocks up on Street-beating Q4 results
Neuronetics (NSDQ:STIM) this week posted fourth-quarter results that beat the consensus forecast on Wall Street. The Malvern, Penn.-based company reported profits of $3 million, or -41¢ per share, on sales of $17.4 million for the three months ended Dec. 31, 2019, for a bottom-line sales growth of 11% compared with Q4 2018. Earnings per share were […]
Is Medtronic eyeing LivaNova for a takeover?
Some industry analysts are speculating that Medtronic (NYSE:MDT) might want to acquire LivaNova (NSDQ:LIVN) for its neuromodulation business. A source told financial intelligence company Reorg last week that someone pitched the idea to Medtronic, which would divest LivaNova’s cardiovascular business and “certain MDT cardiac surgery products.” “Five sector advisors said such a deal would make sense as […]
Stimwave caves in patent spat with Nevro
Stimwave today announced it will cease all sales of its high-frequency spinal cord stimulation systems in exchange for dismissal of a patent infringement lawsuit brought by rival Nevro (NYSE:NVRO). No damages were awarded to Nevro under the settlement. Redwood City, Calif.-based Nevro brought the suit in February 2019, alleging that Stimwave infringed on patents related to […]
LivaNova adds Verily to depression study
LivaNova (NSDQ:LIVN) announced that it has added Google’s (NSDQ:GOOGL) Verily to its study of vagus nerve stimulation (VNS) therapy for difficult-to-treat depression (DTD). The Recover clinical will gather quantitative data on patient behavior using Verily’s technology and analytics. The data could help the researchers understand depressive episodes and the patient’s response to treatment. Study participants will […]
Dyve Biosciences enrolls first patient in gout trial
Dyve Biosciences announced today that it enrolled its first patient in the Phase 2 clinical study of its DYV-700 topically administered therapeutic for acute gout treatment. Thousand Oaks, Calif.–based Dyve won FDA clearance to begin the Targets Phase 2 trial in December 2019. The double-blind, placebo-controlled, randomized clinical trial is set to evaluate the efficacy […]
U.K.’s NICE recommends Axonics’ device for overactive bladder treatment
The U.K.’s National Institute for Health and Care Excellence (NICE) recommended the sacral neuromodulation (SNM) system developed by Axonics Modulation Technologies (NSDQ:AXNX) for treating overactive bladder in its latest draft guidance. Axonics’ system is the only SNM device approved for full-body MRI scans without needing the device explanted, according to the company. The device itself is […]
ResMed part of $28m fundraise for Nyxoah and its neuromod sleep disorder tech
Nyxoah has raised €25 million (nearly $28 million) in its latest fundraising round, with CPAP maker ResMed (NYSE:RMD) joining as a new shareholder. Nyxoah is a Mont-Saint-Guibert, Belgium–based company with a battery-free, leadless and minimally invasive neurostimulator to treat obstructive sleep apnea. It gained a CE Mark for its Genio system last year. Cochlear (ASX:COH) and several […]
These medical device companies provide the most research payments
The worlds largest medical device companies are spending tens of millions of dollars a year on research payments to doctors and teaching hospitals — but the payments only make up a tiny fraction of their budgets. That was a big takeaway from an analysis of Medical Design & Outsourcing‘s annual Big 100 and the most […]