Shares in Rewalk Robotics Ltd. are on the rise after the FDA awarded its Reboot exoskeleton device breakthrough device designation status. The wearable, battery-powered device is designed to assist individuals with lower limb disability due to stroke.
Vagus nerve stimulation (VNS) researchers notched another success with FDA approval of a drug-free rehabilitation system that uses the technology to help patients who have lost mobility in their hands and arms as a result of ischemic stroke regain function. Microtransponder Inc.’s Vivistim pairs rehabilitation exercises with VNS to enhance their impact. The clinical study evaluated by the FDA for the system's approval showed that Vivistim doubled the improvement in upper extremity motor function compared to supervised rehabilitative exercises alone at six weeks and 90 days.
Helius Medical Technologies Inc. has received an FDA breakthrough device designation for its Portable Neuromodulation Stimulator (Pons) device for temporary treatment of dynamic gait and balance deficits due to stroke.
TORONTO – Fluid Biotech Inc. has raised $4.7 million in oversubscribed seed funding to further develop and commercialize the world's first hybrid polymer-metal flow-diverting brain stent for curing brain aneurysms that can lead to stroke. Following successful preclinical studies of the stent, attention now turns to applying this fresh capital to hiring contract manufacturers to prepare for first-in-human implantation and production of the mostly polymer-constructed stent.
Using a minimally invasive brain implant, Feinstein Institutes for Medical Research scientists produced tingling sensations in the fingers of patients who lacked the sense of touch as a result of nerve damage, according to a study published in Brain Stimulation. A second study by the team, which appeared in Frontiers in Neuroscience, used stereoelectroencephalography (SEEG) electrodes to decode neural signals to improve the hand control algorithms in brain-computer interfaces.
Keystone Heart Ltd. had the unusual experience of being the sponsor of a rare class II device appearance before an FDA advisory committee, which considered whether the company’s Triguard 3 device was substantially equivalent (SE) to a predicate device. However, the company’s bid for an SE result was unsuccessful, likely leaving Keystone with a considerable additional regulatory lift before the company can get to market.
In the largest private fundraising round for a U.S. medical device company in the past year, Imperative Care Inc. closed $260 million in a series D financing round on Thursday. The company also acquired its spinoff Truvic Medical Inc., a peripheral thrombectomy developer.
Investigators at the Tokyo Metropolitan Institute of Medical Science have identified the oxidative stress sensor DJ-1 as a previously unknown inflammatory molecule which is released from damaged neurons to activate macrophages in post-stroke neuroinflammation.
The FDA has granted de novo authorization to Neurolutions Inc. for its Ipsihand upper extremity rehabilitation system. The first-of-its kind device leverages robotics and brain-computer interface (BCI) technology to facilitate muscle training in patients with upper limb weakness or immobility following a stroke.
TORONTO – Robotics researchers at Ontario’s University of Waterloo are stealing a page from makers of autonomous or self-driving vehicles, developing wearable, motor-controlled technology to restore physical mobility in people with disabilities without the need to think about or guide the system. The project, called Exonet, is being led by Brokoslaw Laschowski, who contrasts this approach with engineers ramping up the ability of users to control the exoskeleton.
