Woven Orthopedic Technologies LLC secured a second U.S. FDA 510(k) clearance for the use of its Ogmend implant enhancement system in spine surgery. The approval is for the large size Ogmend sleeve which is compatible with pedicle screws up to 10.5 mm and will give surgeons a tool to be able to easily secure stable fixation between the screw and bone during orthopedic surgery.
Early-stage health care companies developing breakthrough medical technologies were given some good news recently with the launch of a new accelerator program by Israel’s Arc Innovation aimed at giving startups a $250,000 cash injection. With a $10 million investment from Ilex Medical Ltd., the initiative is looking to empower early-stage companies by providing financial backing, expert guidance and a support network.
Vessi Medical Ltd. recently closed a series A financing round at $16.5 million for the advancement of its cryotherapy technology to treat non-muscle invasive bladder cancer (NMIBC). Vessi believes that its minimally invasive device can provide a therapeutic alternative to a transurethral resection of bladder tumor (TURBT) procedure, the current first line therapy to treat the disease.
The U.K.’s National Institute for Health and Care Excellence (NICE) has given people looking to lose weight another treatment option by recommending endoscopic sleeve gastroplasty (ESG) as a therapy to help treat obesity. The move comes amidst increasing awareness of the disease brought on by the growing prevalence of GLP-1 agonists.
The €173 million (US$187 million) in capital that Earlybird Health recently raked in from investors will go towards bolstering investment in European health care startups, many of which are still recovering from the impact of COVID-19, Thom Rasche, a partner at Earlybird Health, told BioWorld. The fund is looking to invest in the technologies that can improve patient care.
X-trodes Ltd. has received U.S. FDA 510(k) clearance for its Smart Skin solution, a wireless wearable technology that allows for medical-grade electrophysiological monitoring in clinics and at home. The company believes that the Smart Skin technology, which captures signals from the brain, heart, eyes and muscles, has the potential to significantly improve patient care.
Wandercraft SAS broadened its U.S. FDA clearance for the Atalante X to include rehabilitation in individuals with spinal cord injuries at levels T5 to L5. The self-balancing exoskeleton was already given the greenlight by the FDA for use in stroke rehabilitation in December 2022. “We are thrilled to have two FDA clearances, first for stroke and now spinal cord injury, in less than a year,” CEO Matthieu Masselin, told BioWorld.
Venture capital (VC) firm TVM Capital Life Science recently co-led a $16 million series A financing for Vektor Medical Inc., which has developed an AI-based tool that identifies potential arrhythmia source locations. The funding is part of TVM’s strategy of investing in med-tech companies which have no development risk and offer an exit opportunity in under four years.
The Versavue single-use flexible cystoscope, recently launched by Boston Scientific Corp. in the U.S., could help reduce the risk of infections in patients that comes from the improper reprocessing of reusable cystoscopes, Ron Morton, Boston Scientific chief medical officer, Urology told BioWorld.
Insulet Corp. received the greenlight from EU regulators to combine its Omnipod 5 automated insulin delivery (AID) system with Abbott Laboratories Freestyle Libre 2 Plus sensor to treat individuals aged two years and older with type 1 diabetes.
