BioNess announced today that it won CE Mark approval for its StimRouter neuromodulation system indicated for the treatment of fecal incontinence. The StimRouter system previously won approval for treating chronic pain and overactive bladder. The small implantable system targets the tibial nerve near the ankle. Patients undergoing the StimRouter implant procedure receive one incision as […]
Neuromodulation/Neurostimulation
CES 2020: Medical technologies you need to know
The mobile health devices and wearables trend is seemingly accelerating this year, with 546 digital health and 635 wearable devices being touted at the annual CES show in Las Vegas. Digital health devices and wearables on display are up from the 505 and 620 devices, respectively, presented at CES 2019. Health and medical devices being […]
FDA reduces controls on electrical stimulation devices for anxiety, insomnia
The FDA recently downgraded the cranial electrical stimulator (CES) devices designed to treat anxiety and insomnia from Class III to Class II, leaving CES devices for depression in the most highly regulated Class III category. New CES devices intended to treat anxiety or insomnia will require 510(k) clearance rather than the more stringent premarket review […]
The 10 greatest medtech advances of the 2010s
From disposable endoscopes to TAVR to robotic surgery, there’s a whole host of medtech advances widely available now that weren’t around much 10 years ago. “In terms of technological advances, I would put this past decade as one of the most important for medical technology. From connected devices and robotics, to advances in material sciences […]
NeuroMetrix CEO cuts his salary to $1
Dr. Shai N. Gozani, CEO of pain-treating TENS device company NeuroMetrix (NSDQ:NURO), is cutting his annual salary to $1 from a previous $422,200 — accepting a stock option to purchase 100,000 shares instead. The 2020 executive compensation package, approved Dec. 29 by the company board’s compensation committee, also cuts salaries in return for stock options for […]
Axonics granted nine new patents
Sacral neuromodulation device-maker Axonics Modulation Technologies (NSDQ:AXNX) announced today that it won nine utility patents from the U.S. Patent & Trademark Office in 2019. Axonics’ patents cover the company’s lead design, patient remote control, external trial system, wireless charging, current control stimulation, electromyography and internal system electronics. The patent numbers are: 10,478,619; 10,406,369; 10,384,067; 10,376,704; 10,447,083; 10,449,277 […]
Medtronic wins dismissal of Pennsylvania couple’s DBS lawsuit
Medtronic has prevailed in a personal injury lawsuit over a deep-brain stimulation implant approved by the FDA to treat neurological disorders. A federal judge in Philadelphia on Monday granted the company’s motion to dismiss the lawsuit filed by Edward Walls and his wife, Tonya Chavis-Walls. The couple had claimed in Pennsylvania state court that two […]
Medtronic pain pump recall deemed Class I
The FDA has classified the recall of Medtronic’s (NYSE:MDT) SynchroMed II implantable drug pumps as Class I, the most serious type of recall. The company announced the voluntary recall in October, saying that it had received complaints about the pumps’ motors stalling permanently. Permanent motor stall could prevent the infusion of drugs to the patient, […]
Axonics raises additional $17m in public offering
Sacral neuromodulation device-maker Axonics Modulation Technologies (NSDQ:AXNX) announced that the underwriters of its follow-on public offering exercised in full their option to buy an additional 750,000 shares of common stock. The additional shares are set to be purchased from Axonics at the offering price of $22 per share, less underwriting discounts and commissions, according to a news […]
SPR Therapeutics announces 1000th placement of nerve stimulation device
SPR Therapeutics announced the 1000th commercial placement of its Sprint peripheral nerve stimulation (PNS) system for treating pain. Dr. Henry Vucetic of University Hospitals Case Medical Center (Cleveland) performed the 1000th procedure, treating a patient with shoulder pain due to osteoarthritis. The Sprint PNS system is the only percutaneous PNS device cleared by the FDA […]
Micro-Leads collects $10m for neuromod therapy
Clinical neurostimulation startup Micro-Leads announced that it was awarded $10 million by a National Institutes of Health initiative for funding therapy development. Somerville, Mass.-based Micro-Leads develops the HD64 implantable therapy system for spinal cord stimulation. The device is designed to treat lower back pain and focal pains of the trunk and extremities by delivering electrical […]