NeuroMetrix (NSDQ:NURO) announced that it launched the Quell Watch App for transcutaneous electrical nerve stimulation (TENS). Woburn, Mass.-based NeuroMetrix’s Quell app, which is now available for download from the Apple App Store, allows users of the Quell system to personalize and manage their therapy discreetly on iPhone and Android smartphones, according to a news release. Quell […]
FTC to refund Neurometrix consumers $3.9M in false ad case
The Federal Trade Commission announced that it is refunding NeuroMetrix (NSDQ:NURO) consumers nearly $3.9 million after false advertising. NeuroMetrix marketed its Quell transcutaneous electrical nerve stimulation device as a clinically proven and FDA-cleared treatment for widespread chronic pain relief when placed below the knee, according to the FTC, which said that the company lacks scientific evidence […]
Theranica lands CE mark for migraine device
Theranica announced today that it received CE Mark approval for its Nerivio device for the acute treatment of migraine. Montclair, N.J.-based Theranica adds European approval just over a year since it received FDA de novo clearance for the neurostimulation device in May 2019. The approval allows for the company to begin marketing the device in […]
The 18 most innovative medical devices of 2020
The Galien Foundation recently announced nominees for most innovative medical devices for its 14th Annual Prix Galien USA Awards. The foundation bestows the Prix Galien Award annually to examples of outstanding biomedical and technology products that are designed to improve the human condition. “As we celebrate 50 years of the Prix Galien process, we are honored […]
People can now control their Abbott neuromod device over their iPhone
Abbott (NYSE:ABT) announced today that it received FDA approval for the use of its Patient Controller app on compatible Apple smartphone devices. The company’s Patient Controller app offers management tools for patients with implanted neuromodulation devices to treat conditions such as chronic pain or movement disorders. Now, with the latest approval from the FDA, it’s possible […]
NeuroMetrix improves bottom line despite nearly halved Q2 sales
NeuroMetrix (NSDQ:NURO) shares dipped today after posting second-quarter results that reflected the effects of the COVID-19 pandemic. The Woburn, Mass.-based pain-treating transcutaneous electrical nerve stimulation (TENS) device developer posted losses of -$851,944 on sales of $$1.4 million for the three months ended June 30, 2020, for a 74.7% bottom-line gain on a sales decline of 42.2%. […]
FDA approves Mainstay Medical neurostim device
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 […]
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