Cala Health last month launched a clinical trial of the latest version of its wearable neurostimulator for treating essential tremor, eyeing extended use of the wrist-worn device. The Burlingame, Calif.-based company won de novo clearance from the FDA last April for the Cala One device for transient relief in adults with essential tremor. The 500-patient, single-arm […]
Bioness launches peripheral nerve stim registry
Bioness today launched a patient registry for people using its StimRouter neuromodulation system for peripheral nerve stimulation. Starting in the first quarter of 2019, patients will be able to opt into the StimRouter Registry, according to the Valencia, Calif.-based company. Bioness’ StimRouter was launched in 2016 and the company touts it as the first neuromodulation […]
Inspire Medical Systems scores win with Blue Cross Blue Shield Association
Inspire Medical Systems – creator of a pacemaker-like system to treat obstructive sleep apnea – said today that the Blue Cross Blue Shield Association’s Evidence Street issued a positive assessment of Inspire therapy to its members. BCBSA is a national federation of 36 Blue Cross and Blue Shield companies. The report from BCBSA, according to Inspire […]
Atlantic Therapeutics raises $32m Series B for garment-based UI stimulator
Atlantic Therapeutics said yesterday that it raised a Series B round worth $32 million for the garment-based device it makes to treat stress urinary incontinence. Innovo, an externally worn electrical muscle stimulation device, has CE Mark approval in the European Union and recently won de novo clearance from the FDA, Galway, Ireland-based Atlantic Therapeutics said. Clinical […]
Closed-loop device uses light to control overactive bladder
A team of neuroscientists and engineers has developed a tiny, implantable, closed-loop device that may replace medication or electronic stimulators for bladder disorders. The team from Washington University School of Medicine in St. Louis, the University of Illinois at Urbana-Champaign, and the Feinberg School of Medicine at Northwestern University in Chicago created a soft, implantable […]
Axonics submits interim data to FDA for sacral neuromod device
Axonics Modulation Technologies (NSDQ:AXNX) said today that it submitted interim clinical data from the pivotal study of its implantable sacral neuromodulation system to the FDA. The company is evaluating its r-SNM system as a therapy for people with urinary dysfunction. Axonics’ interim analysis was submitted as a supplement to the company’s “literature-based” premarket approval application. The […]
What should the Mann Foundation do next?
Dr. Robert Greenberg, the Mann Foundation’s new executive chairman, has ideas about where to take one of medtech’s top research and development outfits. He explained more at DeviceTalks West in December. The new executive chairman of the Alfred E. Mann Foundation for Scientific Research sees the foundation continuing its mission of developing devices for unmet medical needs. The foundation […]
‘Pacemaker for the brain’ could help people with epilepsy, Parkinson’s
A new neurostimulator developed by engineers at the University of California, Berkeley, can listen to and stimulate electric current in the brain at the same time, potentially delivering fine-tuned treatments to patients with diseases like epilepsy and Parkinson’s. The wireless, artifact-free neuromodulation device (WAND) works like a “pacemaker for the brain,” monitoring its electrical activity […]
Medtronic wins FDA nod for InterStim sacral neuromod programmer
Medtronic (NYSE:MDT) said today that the FDA approved its InterStim smart programmer, designed to work with the company’s InterStim sacral neurmodulation system intended for tor treating overactive bladder, chronic fecal incontinence and non-obstructive urinary retention. The newly cleared smart programmer is run on a Samsung Electronics (LON:BC94) mobile device and allows clinicians to personalize patient care and manage […]
Rights offering pulls in $45m for Pulse Biosciences
Pulse Biosciences (NSDQ:PLSE) said today that it raised $45 million in an over-subscribed rights offering. The price per share for the offering, which closed yesterday, was equivalent to the five-day volume-weighted average share price at $12.5658 apiece, Hayward, Calif.-based Pulse said. The company received subscriptions and over-subscriptions for 4,023,779 shares, topping the original offering of 3,581,148 […]
Axonics bids for FDA approval of sacral neuromod device
Fresh from a $138 million initial public offering, Axonics Modulation Technologies (NSDQ:AXNX) said today that it re-filed yesterday for pre-market approval from the FDA for its r-SNM sacral neuromodulation treatment for urinary and bowel dysfunction. The Irvine, Calif.-based company said it last month withdrew the PMA application it filed in January 2018 after an FDA […]
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