NeuroMetrix said on Tuesday that it initiated a process to review strategic options to grow its neuromodulation and neurodiagnostic businesses. The Woburn, Massachusetts-based company wants to promote the growth of its Quell and DPNCheck offerings and maximize shareholder value. It said it plans to consider a wide range of options. That could include marketing strategies, […]
Neuromodulation/Neurostimulation
FDA approves MRI labeling on Mainstay Medical’s ReActiv8 restorative neurostimulation system
Mainstay Medical this week announced it received FDA approval for MRI labeling on its ReActiv8 restorative neurostimulation system. The approval allows patients implanted with the 45 cm ReActiv8 leads to be eligible for full-body MRI scans. Patients will be able to undergo 1.5T full-body MRI scans. Specific scan conditions and safety information are provided in […]
LivaNova to lay off 137 in Pennsylvania
LivaNova plans to lay off 137 employees at its Pittsburgh, Pennsylvania location by the end of this year. Shares of LIVN fell 0.7% at $50.37 apiece in midday trading today. The Pennsylvania Dept. of Labor and Industry included LivaNova in its January notices under the Worker Adjustment and Retraining Notification (WARN) Act. Layoffs began taking […]
Inspire Medical stock falls despite 40% Q4 sales growth, Wall Street beats
Inspire Medical Systems (NYSE:INSP) shares took a hit today despite fourth-quarter results that beat the consensus forecast. Shares of INSP fell nearly 7% at $210.35 apiece in midday trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — stayed even. The Minneapolis-based maker of neuromodulation implants for […]
ShiraTronics completes implantable migraine therapy pilot enrollment, sets up U.S. clinical study
ShiraTronics announced that it completed enrollment in a pilot study of its minimally invasive implantable migraine therapy. Minneapolis-based ShiraTronics designed its neuromodulation system to address the debilitating symptoms of migraines. The company says it offers the first-ever fully implantable system for head location utilizing a minimally invasive approach. The fully implantable, programmable device delivers precise […]
FDA expands approval for Boston Scientific spinal cord stim to include chronic back pain without prior back surgery
Boston Scientific announced today that the FDA approved an expanded indication for its WaveWriter spinal cord stimulation (SCS) systems. The indication covers chronic low back and leg pain in people without prior back surgery — called non-surgical back pain (NSBP). Boston Scientific says first-line treatment for people with chronic back pain tends to have limitations. […]
LivaNova picks longtime J&J exec as new CEO
LivaNova announced today that its board of directors appointed Vladimir A. Makatsaria as its CEO and a member of the board. The appointment goes into effect on March 1, 2024. He succeeds Bill Kozy, who took over the CEO role on an interim basis in April 2023 when Damien McDonald resigned from the corner office. […]
Inspire Medical CEO takes over as board chair
Inspire Medical Systems (NYSE:INSP) announced today that Marilyn Carlson Nelson retired as chair of the company’s board of directors. The Minneapolis-based sleep apnea treatment developer appointed current CEO Timothy Herbert to the additional role of board chair. Herbert’s appointment goes into effect after the company’s annual meeting of stockholders on May 2, 2024. Nelson became […]
Avation Medical raises $22M for closed-loop wearable neuromod tech
Avation Medical announced today that it raised $22 million in a Series C financing round to support its wearable peripheral neuromodulation technology. New investors ShangBay Capital and Asahi Kasei led the round. Other new investors included Angelini Ventures, JobsOhio Growth Capital Fund and more. Existing investors Arboretum Ventures, Tonkawa, Medtronic and Avestria Ventures participated, too. […]
Augmedics CEO is taking over corner office at CVRx
CVRx (Nasdaq:CVRX) announced today that it appointed Kevin Hykes as its new president and CEO, effective Feb. 12. Hykes already has familiarity with the Minneapolis-based neurostimulation technology developer, having joined its board in December 2022. He will continue to serve on the board, with CEO Nadim Yared set to retire from the company and resign […]
Magstim wins FDA nod for latest transcranial magnetic stim tech
Magstim announced today that it received FDA clearance for its Horizon 3.0 transcranial magnetic stimulation (TMS) system with StimGuide Pro. The latest platform builds on the previous H 3.0 system for treating patients with depressive or obsessive-compulsive conditions. Horizon 3.0 with StimGuide Pro is the first integrated TMS system with navigation, Magstim said in a […]