Blackrock Neurotech and the University of Pittsburgh’s Rehab Neural Engineering Labs (Pitt RNEL) are working together on the first portable brain-computer interface (BCI) to allow patients to participate in research trials from home. A Blackrock representative said it’s the final step as the company prepares to launch its first commercial product early next year. Salt Lake […]
SpineX announced today that it enrolled the first patient in its pivotal trial evaluating the Scone neuromodulation device. Los Angeles-based SpineX will evaluate the safety and effectiveness of the non-invasive spinal neuromodulation technology for the treatment of neurogenic bladder. The first patient was enrolled at the Rancho Research Institute of the Rancho Los Amigos National […]
Carthera announced today that it received FDA breakthrough device designation for its SonoCloud-9 system. Paris-based Carthera designed SonoCloud-9 for implantation in a skull window below the skin. Once in place, the device becomes invisible. When activated for a few minutes using a transdermal needle connected to an external control unit, it uses low-intensity pulsed ultrasound […]
Pear Therapeutics (Nasdaq:PEAR) today shared real-world data highlighting low costs with its reSET-O prescription digital therapeutic (PDT). Boston-based Pear Therapeutics’ reSET-O represents the only FDA-authorized PDT for the treatment of opioid use disorder (OUD). Get the full story at our sister site, Drug Delivery Business News.
Ekso Bionics (Nasdaq:EKSO) announced today that it received FDA 510(k) clearance for its EksoNR robotic exoskeleton. Richmond, California–based Ekso Bionics designed the EksoNR technology for use with Multiple Sclerosis (MS) patients. According to a news release, EksoNR is the first exoskeleton device to receive FDA clearance for rehabilitation use in patients with MS, significantly expanding […]
Pear Therapeutics (Nasdaq:PEAR) today announced real-world data from a trial of its Somryst prescription digital therapeutic (PDT). Data showed that Somryst, the only FDA-authorized PDT for treating chronic insomnia, achieved significant reductions in symptoms of insomnia, anxiety and depression severity both immediately following treatment and at six-months follow-up. Get the full story at our sister site, […]
Better Therapeutics (Nasdaq:BTTX) announced today that it appointed Frank Karbe as its new president and CEO. San Francisco-based Better Therapeutics develops prescription digital therapeutics (PDTs) based on nutritional cognitive behavioral therapy (nCBT) to address the root causes of cardiometabolic diseases. Get the full story at our sister site, Drug Delivery Business News.
Medtronic (NYSE:MDT) this week announced that it has appointed Dr. Ashwini Sharan as its neuromodulation operation unit chief medical officer. Sharan will be responsible for shaping the strategic direction of the Fridley, Minnesota-based company’s innovation and clinical evidence plans and help guide physician, society and education engagements. He will also serve as a medical advisor […]
InVivo Therapeutics (Nasdaq:NVIV) announced today that it completed enrollment in the Inspire 2.0 study for patients with acute spinal cord injury. Cambridge, Massachusetts–based InVivo’s 20-patient randomized, controlled trial aims to enhance the clinical evidence for the company’s Neuro-Spinal Scaffold. The company designed the Neuro-Spinal Scaffold to encourage functional cells to fill a cavity that will […]
Monteris Medical announced today that data supports the use of its laser interstitial thermal therapy (LITT) in treating brain tumors. A paper on LITT for patients with IDH wild-type glioblastoma — the most common and aggressive tumor originating in the brain — was published in the journal Neuro-Oncology Advances. Minnetonka, Minnesota-based Monteris said in a […]
Axonics (Nasdaq:AXNX) announced that it filed a premarket approval (PMA) supplement with the FDA for its next-generation neurostimulator. Irvine, California–based Axonics designed its fourth-generation rechargeable sacral neuromodulation implantable neurostimulator (INS) to reduce the frequency with which a patient needs to recharge their implanted device to just once every six months for one hour. The current […]