Greatbatch (NYSE:GB) said today that its board of directors approved the spinout of its QiG Group, which is slated to become Nuvectra Corp. once the deal closes, expected March 7. One Nuvectra share is due to be distributed to Greatbatch shareholders March 14, for every 3 GB shares, the Frisco, Texas-based company said. “This announcement marks an important […]
Neuromodulation/Neurostimulation
‘Stentrode’ could revolutionize thought-control tech
(Reuters) — Powered exoskeletons that allow the paralyzed to walk are at the forefront of medical technology. Now Australian scientists are set to revolutionize the field with an ambitious new project. They’ve invented the “stentrode,” a 3mm-wide metal device designed to access brain signals and allow patients to move artificial limbs or wheelchairs. “This is an […]
Calmare wins $15m DoD contract
Pain mitigation company Calmare Therapeutics said yesterday it won a general supply order contract from the U.S. Department of Defense for an estimated $15 million over the next 60 months. The Fairfield, Conn.-based company’s flagship product is its Calmare Pain Therapy Device, which is designed as a non-invasive and non-addictive neuropathic pain treatment modality, and has […]
St. Jude wins FDA green light for Axium chronic pain device
St. Jude Medical (NYSE:STJ) said today it won FDA premarket approval for its Axium neurostimulator system using dorsal root ganglion stimulation. The device from St. Paul, Minn.-based St. Jude is designed to treat moderate to severe chronic intractable pain of the lower limbs in adult patients with complex regional pain syndrome. “The approval of St. Jude Medical’s […]
FDA expands approval for Medtronic’s deep-brain stimulation for Parkinson’s
Medtronic (NYSE:MDT) said today that it won expanded approval for its deep-brain stimulation therapy for patients with Parkinson’s disease, which 1st won approval from the safety watchdog in 2002. The expanded approval covers patients who have had a Parkinson’s diagnosis for 4 years and recently developed motor complications, or have long-standing motor complications that can’t be […]
OrthoCor picked up by veterinary med device firm Caerus Corp
Non-invasive medical device maker OrthoCor said yesterday it was acquired by veterinary-focused medical device firm Caerus Corp, who said the company will remain independent and focused on the orthopedic market. OrthoCor’s flagship product is its Active System, which uses pulsed electromagnetic field technology to reduce joint pain and restore physical function to patients, the company […]
FDA proposes to require PMAs for cranial electrotherapy stimulators for depression
The FDA is proposing to require manufacturers of cranial electrotherapy stimulators to submit pre-market approval applications if their devices are intended to treat depression. The federal safety watchdog said it’s also proposing to down-classify CES devices aimed at treating insomnia and anxiety from Class III, which would also require PMA applications, to Class II subject to […]
St. Jude Medical rejiggers sales reporting
St. Jude Medical (NYSE:STJ) said today that it plans to rejigger the way it reports its sales to better reflect its focus in managing the business, beginning this year. Little Canada, Minn.-based St. Jude, which saw its share price slide today after missing forecasts for its 4th-quarter sales, said it’s focus is shifting to 5 key key areas: Heart failure; atrial […]
NeuroMetrix jumps on next-gen Quell FDA nod, but can’t hold momentum
NeuroMetrix (NSDQ:NURO) saw shares jump as high as 37% yesterday after announcing it won FDA 510(k) clearance for an upgraded version of its Quell wearable over-the-counter chronic pain relief device, though shares haven’t held onto the inertia in trading today. The new model is designed to be controlled through a company-developed smartphone app, and has an […]
Helius draws down $5m, reups U.S. Army deal
Helius Medical Technologies (OTC:HSDT) said it drew down on the $5 million remaining in its credit facility from a Chinese investor and extended a research deal with the U.S. Army. Newtown, Pa.-based Helius said that in return for the draw-down, it gave A&B Co. Ltd., its partner in a deal to develop and commercialize its Portable Neuromodulation Stimulator in Asia, […]
Soterix Medical wins CE Mark for tDCS depressive disorder therapy
Depression-treating neuromod developer Soterix Medical said yesterday it won CE Mark approval in the European Union for its 1×1 tDCS therapy system designed to treat major depressive disorder. The 1×1 tDCS system is a non-invasive therapeutic device that uses low-intensity direct current to stimulate a region of the cerebral cortex that controls mood, according to […]