MicroTransponder (Austin, Texas) recently announced the first commercial implantation of its Vivistim paired VNS system for chronic ischemic stroke rehabilitation. Dr. Charles Y. Liu, director of the University of Southern California Neurorestoration Center, and Dr. Jonathan J. Russin, director of the USC Neuro Revascularization Center, successfully placed the small Vivistim device under the skin of […]
Neuromodulation/Neurostimulation
NeuroMetrix’s Quell neuromodulation device wins FDA de novo nod to treat fibromyalgia
NeuroMetrix (Nasdaq:NURO) announced today that it received FDA de novo authorization for its Quell neuromodulation device. Quell received the authorization as an aid for reducing the symptoms of fibromyalgia in adults with high pain sensitivity. Quell garnered FDA breakthrough device designation to treat fibromyalgia in July 2021. Much like when it received the breakthrough nod, […]
FDA approves magnetic resonance labeling for CVRx’s Barostim neuromodulation system
CVRx (Nasdaq:CVRX) announced today that the FDA approved magnetic resonance (MR) conditional labeling for its Barostim system. The Barostim neuromodulation system for treating the symptoms of heart failure now includes instructions to allow for safe MRI scans of the head and lower extremities, offering heart failure patients implanted with Barostim more diagnostic options. Minneapolis-based CVRx […]
Axonics raises 2022 sales guidance on Street-beating Q1
Axonics Modulation Technologies (Nasdaq:AXNX) reported first-quarter financial results that topped analysts’ consensus forecast. The Irvine, California–based sacral neuromodulation technology developer posted losses of $22.7 million, or 50¢ per share, on sales of $48.4 million for the three months ended March 31, 2022, for a slight bottom-line loss of just over $150,000 year-over-year on sales growth […]
Avanos rises as Q1 earnings match Wall Street projections
Avanos Medical (NYSE:AVNS) shares ticked up today on first-quarter results that just about matched the consensus forecast. The Alpharetta, Georgia–based pain management and chronic care device company posted profits of $5.8 million, or 12¢ per share, on sales of $197.4 million for the three months ended March 31, 2022, for a bottom-line gain from losses […]
Stevanato Group, Bexson expand partnership for wearable drug delivery device
Stevanato Group and Bexson Biomedical announced today that they agreed to expand their drug delivery collaboration. Under the agreement, Bexson has access to the use of a customized version of Stevanato’s SG EZ-be Pod wearable delivery system so it can develop new therapeutics for treating an array of mental health conditions, including treatment-resistant depression and post-traumatic stress disorder […]
Ear-puffing device for migraine treatment wins FDA breakthrough designation
A handheld device that treats migraine attacks with puffs of air in a patient’s ears has been designated a breakthrough device by the FDA. Tempe, Arizona-based Nocira said it is the first company to announce breakthrough device designation for treating migraine attacks in both chronic and non-chronic migraine patients ages 18 and up. The device […]
Inspire Medical Systems invests in EnsoData and Ognomy
Sleep apnea treatment developer Inspire Medical Systems has invested in two private companies with digital health tech that could better screen people for sleep problems. Minneapolis-based Inspire Medical is the maker of a minimally-invasive, implantable device that uses neurostimulation to treat obstructive sleep apnea. It made a $10 million minority equity investment in Madison, Wisconsin–based […]
18 of the world’s most innovative medical technologies
Judges this week are voting for the most innovative medical technologies among the nominees for the 2022 Prix Galien International Awards. The Prix Galien International Awards highlight the most innovative technologies in the life sciences industry. The New York-based Galien Foundation presents the international award to eligible nominees that have received a Prix Galien award […]
Medtronic warns on some Percept neurostimulators
Medtronic (NYSE:MDT) has issued an urgent field safety notice in Europe regarding its Percept PC implantable neurostimulator (INS). The letter informs users that, in rare instances (0.044%), the Percept PC INS Model B35200 can’t communicate with the clinician programmer and/or the patient programmer system (HH90 Handset and TM91 Communicator). According to the safety notice, in […]
NeuroMetrix revenues rise in Q1
NeuroMetrix (Nasdaq:NURO) shares dipped today on first-quarter results that saw losses despite year-over-year revenue growth. The Woburn, Massachusetts–based company posted losses of $958,562, or 14¢ per share, on sales of $2.3 million for the three months ended March 31, 2022, for a bottom-line slide deeper into the red on sales growth of 6.8%. NeuroMetrix’s biggest […]