Neurometrix Inc. secured breakthrough device designation from the FDA for its Quell technology for chemotherapy-induced peripheral neuropathy (CIPN) just six months after receiving the designation for fibromyalgia in July 2021. Quell is a wearable, credit card-sized transcutaneous electrical nerve stimulation (TENS) device worn on the upper calf that delivers self-adjusting, high-power nerve stimulation that disrupts pain signals sent to the brain.
Medtronic plc received FDA premarket approval Friday for use of its Intellis rechargeable and Vanta recharge-free neurostimulators in patients with diabetic peripheral neuropathy (DPN), suddenly tripling the number of spinal cord stimulators approved for the indication. Medtronic’s implantable spinal cord stimulators (SCS) now join Nevro Corp.’s HFX, which has had the distinction since July 2021 of being the only device with FDA approval for DPN, also known as painful diabetic neuropathy (PDN).
Each year, more than 250,000 Americans undergo sinus surgery to treat a range of nose and sinus complaints. Full recovery can take several weeks, during which patients typically use opioids to treat their postoperative pain. Given the risk of opioid addiction, Tivic Health Systems Inc. is testing a bioelectronic device that offers an alternative to potent narcotics following sinus surgery.
Medtronic plc released initial results showing meaningful pain relief using differential target multiplexed (DTM) spinal cord stimulation (SCS) endurance therapy, a lower-energy form of its DTM SCS treatment for overall, back or leg pain. At three months, patients in the on-label, prospective, multicenter study reported that their overall pain was about half what it was at the start of the study, measured by a 3.9 cm reduction on the 10 cm Visual Analog Scale (VAS) vs. 7.8 cm at baseline. Patients in the study also reported an average decrease in back and leg pain or 4.3 cm and 5.0 cm, respectively. Medtronic plans to offer the DTM SCS endurance therapy on its rechargeable Intellis and primary cell Vanta platforms.
That excruciating moment when patients learn their lives are potentially at risk to a “wide neck” brain aneurysm could be softened by results of a long-awaited international study led by researchers at Massachusetts General Hospital (MGH) and Harvard Medical School. According to lead author Adam Dmytriw, wide-neck aneurysms will respond better to the Woven Endobridge Web device than metal stents and blood thinners.
Space travel has known effects on human health and biology. Some, such as loss of bone density, are well understood, while others, like inflammation, are not. Now, organ-on-a-chip maker Emulate Inc. is conducting experiments on the International Space Station U.S. National Laboratory (ISS-NL) aimed at revealing clues to how the brain functions in microgravity.
Jelikalite Corp. has received a breakthrough device designation from the FDA for its wearable neurostimulation device Cognilum. The home-based system aims to reduce symptoms of moderate to severe autism spectrum disorder in pediatric patients aged 2 to 6 years. The designation was based on the results of a double-blind, placebo controlled clinical trial of 30 pediatric patients with moderate to severe autism, which showed the technology can significantly improve symptoms.
Synchron Inc. closed out 2021 by providing an opening for a patient with amyotrophic lateral sclerosis (ALS) to send the first thought transferred to a tweet via an implantable brain computer interface. Philip O’Keefe, who received one of the company’s Stentrode implants in April 2020, took over the Twitter account of Sychron CEO Thomas Oxley to say, “Hello, World. Short tweet. Monumental progress.”
PARIS – Two months after successfully listing on Euronext Brussels and Euronext Amsterdam stock exchanges, raising nearly $100 million, Onward Medical NV reported completion of enrollment in its Up-LIFT study on its noninvasive electrical spinal cord stimulation, called Arc therapy.
Movendo Technology srl and Maragal Medical PC have collaborated to provide free community screening for the risk of falls for Massachusetts Medicare patients using Movendo’s Hunova robotic technology. Hunova performs a progressive assessment on seated and standing patients to evaluate their flexibility, strength and balance. The system also provides personalized rehabilitative therapy recommendations.