WAT Medical this week won FDA clearance for over-the-counter use of its HeadaTerm 2 wearable anti-migraine device. HeadaTerm 2 uses neuromodulation technology. It releases targeted electrical impulses that increase the pain tolerance of the wearer. It is FDA-cleared for the preventative treatment of migraine headaches and is available without a prescription in the U.S. HeadaTerm2 […]
Neuromodulation/Neurostimulation
Onward submits movement-restoring spinal cord stim tech to FDA
Onward Medical announced today that it submitted a de novo application to the FDA for the approval of its ARC-EX spinal cord stimulation system. The Eindhoven, the Netherlands-based company designed ARC-EX to restore function of upper extremities after spinal cord injury (SCI). If approved, the company says ARC-EX would become the first ever SCS therapy […]
FDA wants to ban electrical stimulation devices for self-injurious, aggressive behavior
In a rare move, the FDA is taking steps to ban electrical stimulation devices (ESDs) for self-injurious or aggressive behaviors. Owen Faris, acting director of the Office of Product Evaluation and Quality (OPEQ) in the FDA’s Center for Devices and Radiological Health, announced the proposal this week, marking the second attempt by the agency to […]
Fast Company names 10 medtech companies as most innovative of 2024
Fast Company recently named 10 medical device companies as some of the most innovative companies of 2024. Each year, Fast Company releases its list of the world’s most innovative companies. The list covers 58 industries and sectors, ranging from advertising to video. Companies on the “Most Innovative” list apply to be included, and then Fast […]
FDA clears Neuronetics’ neurostim for adolescents with depression
Neuronetics (Nasdaq:STIM) announced today that it received FDA clearance for the use of its NeuroStar therapy for adolescent patients. Clearance covers the use of NeuroStar as an adjunct treatment of major depressive disorder (MDD) in adolescent patients aged 15-21. Neuronetics said clearance makes NeuroStar the first and only transcranial magnetic stimulation (TMS) treatment cleared for […]
PTAB upholds two Medtronic patents in spat with Axonics, could go to jury trial
Medtronic announced today that the U.S. Patent and Trademark Office upheld many of its claims around two of its patents in its battle with Axonics (Nasdaq:AXNX). The office’s Patent Trial and Appeal Board (PTAB) affirmed the validity of many of the claims in two of Medtronic’s patents in the latest development in a long-running spat […]
FDA adds SetPoint Medical and its multiple sclerosis-treating neuromod to advisory program
SetPoint Medical announced today that the FDA accepted it into the Total Product Life Cycle Advisory Program (TAP) pilot. TAP provides early and frequent strategic engagement from the FDA, patients, providers and payers. It facilitates rapid development and widespread access to medical devices. Acceptance requires breakthrough device designation, which SetPoint Medical garnered last week. With […]
Onward raises $22M to support neurostim tech
Onward Medical announced today that it successfully raised $21.8 million (€20 million) in gross proceeds through a private placement. The company offered more than 4.4 million new ordinary shares at an issue price of $4.89 (€4.50) per share. It completed the offering with participation from institutional investors, certain founders and management and members of the […]
LivaNova reports positive study results for neuromod for sleep apnea
LivaNova today announced positive outcomes from a study of its nerve stimulator system for treating sleep apnea. The company said its OSPREY clinical trial achieved a positive predictive outcome and concluded enrollment earlier than anticipated. This means the company projects a greater than 97.5% probability that OSPREY successfully meets its primary endpoint. London-based LivaNova’s OSPREY […]
Axonics wins CE mark for 4th-gen rechargeable sacral neuromod system
Axonics (Nasdaq:AXNX) announced today that it received CE mark approval for its R20 rechargeable sacral neuromodulation (SNM) system. The implantable system provides therapy for patients suffering from overactive bladder or fecal incontinence. Axonics won FDA approval for this generation of the R20 in January 2023. The R20 neurostimulator uses the same small 5cc form factor […]
Former Stimwave CEO convicted of healthcare fraud
The U.S. Justice Dept. announced last week that a jury found former Stimwave CEO Laura Perryman guilty of healthcare fraud. Damian Williams, U.S. Attorney for the Southern District of New York, last week announced the jury’s verdict. It found Perryman guilty on two counts of an indictment charging her with conspiracy to commit healthcare fraud and […]