Synchron said it has begun the first clinical trial for its neural interface technology designed to restore communication to people with severe paralysis. The trial will measure the safety of the company’s “thought-to-text” technology by assessing its Stentrode implant in combination with BrainOS software and the stability of high-fidelity signals from the brain to external communications […]
Bioelectronic Medicine
FDA issues ‘leap-frog’ guidance on brain/computer interfaces
FDA has issued draft guidance for developers of devices to help amputees and people with paralysis regain mobility or their sense of touch. FDA defines brain/computer interface (BCI) devices as neuroprostheses that interface with the central or peripheral nervous system to restore lost motor or sensory capabilities. The guidance proposes that non-clinical device testing can be used […]
Axonics Modulation touts results of sacral neuromodulation study
Axonics Modulation Technologies (NSDQ:AXNX) announced positive top-line results from a pivotal study of its novel implantable sacral neuromodulation (SNM) devices for the treatment of urinary and bowel dysfunction. The clinical study demonstrated that patients implanted with the Axonics r-SNM system experienced clinically meaningful and statistically significant improvements in urinary urgency incontinence (UUI) symptoms and quality of […]
Swedish patient receives ‘dexterous, sentient’ prosthetic hand
A Swedish woman with a hand amputation has become the first recipient of an osseo-neuromuscular implant to control a dexterous hand prosthesis, according to Chalmers University of Technology in Gothenburg, Sweden. Surgeons placed titanium implants in the two forearm bones (radius and ulna), and extended electrodes to nerves and muscle to extract signals to control a […]
Could this device replace pacemaker batteries?
The heart’s motion is so powerful that it can recharge lifesaving cardiac devices, according to new research from Dartmouth College. Engineers at Dartmouth’s Thayer School of Engineering developed a dime-sized device to convert the heart’s kinetic energy into electricity to power a wide range of implantable devices, according to the Hanover, N.H.-based college. Get the full […]
Pain-management firm SPR Therapeutics seeks to raise $20m
SPR Therapeutics has raised $8 million of a $20 million Series C round of funding that began Jan. 19, according to an SEC filing. The Cleveland-based company’s Sprint peripheral nerve stimulation (PNS) system is FDA-cleared for both chronic and acute pain, including post-operative and post-traumatic pain. The product was launched in November 2018 with indications […]
Tivic Health’s OTC sinus pain device wins FDA nod
Tivic Health Systems said that its ClearUP device for allergy-induced sinus pain has received 510(k) clearance from FDA. ClearUP is an over-the-counter device that provides consumers with a simple, non-invasive and drug-free option to relieve sinus pain caused by various environmental allergies such as dust, mold, pollens and pet dander, according to the […]
What should the Mann Foundation do next?
Dr. Robert Greenberg, the Mann Foundation’s new executive chairman, has ideas about where to take one of medtech’s top research and development outfits. He explained more at DeviceTalks West in December. The new executive chairman of the Alfred E. Mann Foundation for Scientific Research sees the foundation continuing its mission of developing devices for unmet medical needs. The foundation […]
‘Pacemaker for the brain’ could help people with epilepsy, Parkinson’s
A new neurostimulator developed by engineers at the University of California, Berkeley, can listen to and stimulate electric current in the brain at the same time, potentially delivering fine-tuned treatments to patients with diseases like epilepsy and Parkinson’s. The wireless, artifact-free neuromodulation device (WAND) works like a “pacemaker for the brain,” monitoring its electrical activity […]
Medtronic founder Earl Bakken knew how to inspire his employees
Earl Bakken made history when he invented the battery-powered, wearable cardiac pacemaker in a Minneapolis garage in 1957. But three years later, the company he co-founded was floundering and desperately needed cash. To show the board of directors that the $200,000 they had raised would be put to good use, Bakken wrote a mission statement for the […]
IBM’s AI-aided fingernail sensor could help with cardio, Parkinson’s treatment
IBM has developed a fingernail sensor that it says may help healthcare providers fine-tune treatment for certain cardiovascular and neurological conditions such as Parkinson’s disease. The wearable, wireless device measures how a person’s fingernail bends and moves throughout the day – a key indicator of grip strength. The prototype sensor continually collects data and feeds […]