Theranica Bio-Electronics said yesterday that it raised a $35 million Series B round for the Nerivio Migra neurostim patch it’s developing to treat migraine headache. Netanya, Israel-based Theranica said VC shop aMoon led the round, joined by all of its existing backers, Lightspeed Venture Partners, LionBird, Corundum Open Innovation and Takoa. The company raised an […]
Cala Health licenses MGH-developed neuromod tech
Cala Health said this week it inked a deal to license technology from Partners Healthcare and its affiliate Massachusetts General Hospital intended to improve the company’s non-invasive neuromodulation platform for investigating and treating chronic diseases. The licensed technology was developed from research on transcutaneous vagus nerve stimulation and respiratory-gated vagal afferent nerve stimulation at a […]
FDA issues ‘leap-frog’ guidance on brain/computer interfaces
FDA has issued draft guidance for developers of devices to help amputees and people with paralysis regain mobility or their sense of touch. FDA defines brain/computer interface (BCI) devices as neuroprostheses that interface with the central or peripheral nervous system to restore lost motor or sensory capabilities. The guidance proposes that non-clinical device testing can be used […]
Axonics Modulation Technologies slides on misses Q4, 2018 earnings
Axonics Modulation Technologies (NSDQ:AXNX) took a hit after it posted fourth-quarter and 2018 losses that exceeded the consensus forecast on Wall Street. The company is developing a sacral nerve stimulation device to treat incontinence. Irvine, Calif.-based Axonics said yesterday that its losses grew 95.6% to -$9.6 million, or -50¢ per share, on sales of $494,000 […]
Inspire Medical wins more Blue Cross Blue Shield coverage
Five more Blue Cross Blue Shield health plans have extended coverage to Inspire Medical Systems’ (NYSE:INSP) sleep apnea therapy, the company said today. These plans and the effective dates of their coverage are: Independence Blue Cross, in Pennsylvania, March 4, 2019; Blue Cross Blue Shield of Louisiana, Feb. 20, 2019; Wellmark, in Iowa and South […]
FDA clears Axilum Robotics’ system for TMS positioning
Strasbourg, France-based Axilum Robotics said today that it has received 510(k) clearance from FDA for its TMS-Cobot TS MV, indicated for the spatial positioning and orientation of the treatment coil of the MagVenture TMS Therapy system. Transcranial magnetic stimulation (TMS) is a non-invasive neurostimulation technique. Its approved and potential applications range from neuroscience research to the treatment of drug-resistant […]
Axonics wins expanded MRI-safe CE Mark approval for r-SNM system
Axonics Modulation Technologies (NSDQ:AXNX) said today that it won expanded CE Mark approval clearing its r-SNM Sacral Neuromodulation system for use with 1.5T and 3T full body magnetic resonance imaging. The Irvine, Calif.-based company touted the r-SNM as the only implantable SNM system to have received full-body labeling in the EU. “Without this labeling, any patient […]
Stimwave calls Nevro patent suit ‘baseless, unfounded’
Stimwave today responded to a patent infringement suit filed by Nevro (NYSE:NVRO) stating that the claims made against the company are “completely baseless, unfounded and invalid.” In its suit, which was filed in the U.S. District Court for the District of Delaware last week, Nevro claims that Pompano Beach, Fla.-based StimWave infringed on patents related to […]
Axonics Modulation touts results of sacral neuromodulation study
Axonics Modulation Technologies (NSDQ:AXNX) announced positive top-line results from a pivotal study of its novel implantable sacral neuromodulation (SNM) devices for the treatment of urinary and bowel dysfunction. The clinical study demonstrated that patients implanted with the Axonics r-SNM system experienced clinically meaningful and statistically significant improvements in urinary urgency incontinence (UUI) symptoms and quality of […]
Medtronic launches DBS for medically-refractory epilepsy in the U.S.
Medtronic (NYSE:MDT) said today that it launched its Deep Brain Stimulation system intended for medically-refractory epilepsy in the U.S. The Fridley, Minn.-based company said that the first patient was implanted with the system at Atlanta’s Emory University. “At Medtronic, we have a long-standing commitment to helping patients with medically refractory epilepsy through DBS, and we continue […]
Soterix Medical launches tDCS trial for cocaine addiction
Soterix Medical said yesterday that it won a Phase I NIH-SBIR contract from the National Institute of Health’s National Institute of Drug Abuse to launch a trial of its remote transcranial direct current stimulation platform intended to treat cocaine addiction. The Phase I contract comes with a value of approximately $475,000 delivered over a period of […]
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