Mainstay Medical announced that it received FDA premarket approval for its ReActiv8 implantable neurostimulation system for chronic low back pain. ReActiv8 treats intractable chronic low back pain associated with multifidus muscle dysfunction, as evidenced by imaging or physiological testing in adults who have failed therapy and are not candidates for spine surgery, according to a […]
GTX Medical wins FDA breakthrough device designation for targeted epidural spinal stimulation
GTX Medical this week said it received FDA breakthrough device designation for its Go-2 targeted epidural spinal stimulation system. The system is designed to promote the recovery of leg motor functions and neurological control in adults that have spinal cord injuries and paralysis. It improves the reconnection of the brain with paralyzed muscles and individuals […]
Nevro Senza Omnia SCS wins CE Mark
Nevro (NYSE:NVRO) announced today that it has received CE mark approval for the Senza Omnia spinal cord stimulation (SCS) system. The system won FDA approval in November 2019. It is is the first and only SCS system designed to deliver Nevro’s proprietary HF10 therapy, as well as other available SCS frequencies, according to the company. Redwood […]
Avanos up on Street-beating Q1
Avanos Medical (NYSE:AVNS) shares ticked up today on first-quarter results that topped the consensus forecast. The Alpharetta, Ga.-based company posted profits of $3.7 million, or 8¢ per share, on sales of $180.4 million for the three months ended March 31, 2020, recording profits after a $20.3 million loss this time last year on sales growth of […]
NeuroMetrix dips on Q1 losses
NeuroMetrix (NSDQ:NURO) shares fell today on first-quarter losses that reflected the impact of COVID-19 on its business. The Woburn, Mass.-based pain-treating transcutaneous electrical nerve stimulation (TENS) device developer posted losses of -$657,371 on sales of $2.2 million for the three months ended March 31, 2020, seeing its bottom line slide into the red from profits of […]
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 […]
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 […]
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 […]
NANS 2020: Neuromodulation news you need to know
Neuromodulation devices from companies including Medtronic (NYSE:MDT), Abbott (NYSE:ABT) and SPR Therapeutics are showing promise treating pain. That’s one of the initial takeaways from study results that medical device companies in the neuromodulation space are touting this weekend at NANS 2020 in Las Vegas. NANS is a joint conference of Congress of Neurological Surgeons and the […]
Medtronic touts 3-month clinical trial results using Stimgenics spinal cord stimulation
Medtronic (NYSE:MDT) this week touted results from a three-month clinical trial of the recently acquired Stimgenics Differential Target Multiplexed Spinal Cord Stimulation using Medtronic’s Intellis platform. The large, multicenter randomized controlled trial showed that 80% of patients with chronic back pain that were treated with Differential Target Multiplexed (DTM) reported at least 50% pain relief […]
Medtronic acquires Stimgenics
Medtronic (NYSE:MDT) yesterday said it acquired spinal cord stimulation company Stimgenics for an undisclosed amount. Stimgenics has developed a spinal cord stimulation waveform known as Differential Target Multiplexed Spinal Cord Stimulation. The therapy is delivered through Medtronic’s Intellis platform and is a chronic pain treatment option. “Stimgenics’s research is deeply rooted in clinical science that began […]
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