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 […]
Neuromodulation/Neurostimulation
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 […]
SetPoint Medical wins FDA breakthrough nod for nerve stim tech for multiple sclerosis
SetPoint Medical announced today that received FDA breakthrough device designation for its novel neuroimmune modulation platform. Valencia, California–based SetPoint designed its nerve modulation technology for people with relapsing-remitting multiple sclerosis (RRMS). Breakthrough designation enables more communication and priority regulatory review with the FDA. Plus, it supports reimbursement and patient access upon approval. This isn’t the […]
Sooma raises $5.5M for depression-treating neuromod
Sooma Medical announced today that it raised €5 million ($5.5 million) to support its at-home brain stimulation technology. Nordic early-stage investor, Voima Ventures, led the funding round. Singapore-based Verge HealthTech Fund and existing investor Stephen Industries also participated. The funding marks a new phase of growth for Sooma in its mission, the company said in […]
FDA accepts Onward BCI into advisory program
Onward Medical announced today that the FDA accepted it into its new Total Product Lifecycle Advisory Program (TAP) — a move that could boost the development of Onward’s BCI technology. Acceptance into the TAP program comes on the heels of FDA breakthrough device designation for the ARC-BCI system last month. Breakthrough device designation is a […]
Report: Pharyngeal neurostim company Phagenesis raises $42M
Axios reports that British medtech company Phagenesis confirmed that it raised $42 million in a Series D financing round. The outlet says CEO Reinhard Krickl confirmed the Manchester, U.K.–based company’s latest funding. According to the report, EQT Life Sciences and Sectoral led the round, with new investors British Parent Capital, Northern Gritstone and Aphelion joining […]
Medtronic wins FDA clearance for bone tumor ablation tech
Medtronic announced today that it received FDA 510(k) clearance for its OsteoCool 2.0 bone tumor ablation system. The medtech giant designed OsteoCool 2.0 to treat painful bone metastases and benign bone tumors like osteoid osteoma. The minimally invasive procedure uses probes to deliver radiofrequency energy that heats and destroys tumors. Meanwhile, it circulates water to […]
ClearPoint Neuro prices $15M offering
ClearPoint Neuro (Nasdaq:CLPT) announced today that it priced an underwritten public offering worth approximately $15 million. The company is offering 2,307,694 shares of its common stock at a price to the public of $6.50 per share. It also granted the underwriter a 30-day option to purchase up to an additional 346,154 shares of common stock […]
Onward wins FDA breakthrough nod for use of neurostim with brain-computer interface
Onward Medical announced today that the FDA granted breakthrough device designation for its ARC-BCI system that uses brain-computer interface (BCI) technology. ARC-BCI uses BCI technology in conjunction with ARC-IM neurostimulation. It aims to restore thought-driven lower limb mobility after spinal cord injury (SCI). The BCI system uses AI to decode brain signals and translate them […]
Medtronic asks ITC to stop Axonics’ sales of neuromod devices
Medtronic today announced that it filed a complaint to the U.S. International Trade Commission (ITC) to block the sales of certain Axonics (Nasdaq:AXNX) devices. The complaint to the ITC runs parallel to action in the U.S. District Court for the District of Delaware. Medtronic wants to block Axonics from “improperly importing and selling products that infringe […]
BlueWind reports first patient treated in study of neuromod for urinary incontinence
BlueWind Medical announced today that a doctor treated the first patient in the RESTORE study of its Revi iTNM device. Dr. Osvaldo Padron of Florida Urology Partners in Tampa, Florida, treated the first patient. The prospective, multi-center, open-label, post-market, randomized controlled trial aims to recruit 150 patients across up to 20 U.S. centers. BlueWind designed Revi […]