Microtransponder Inc. raked in $53 million in an oversubscribed series E round that exceeded its best previous fundraising by nearly 500% and brought the company’s total funds raised to date to $93 million. The new money will be used to commercialize the Vivistim paired VNS system, which received premarket approval in 2021 as what the FDA called the “first stroke rehabilitation option using vagus nerve stimulation.” Read More
The U.S. FDA has granted Sonivie Ltd. IDE approval for a pilot study to treat resistant hypertension patients with renal artery denervation (RDN) using its Tivus ultrasound ablation system. The intravascular, catheter-based system uses high-frequency non-focused ultra-sound energy to ablate nerves in the renal artery and cause denervation of nerves in other structures such as the bronchus. Read More
The U.S. FDA may be the most advanced regulatory agency when it comes to artificial intelligence (AI) and machine learning (ML), but developers of these products still have little in the way of FDA guidance to work with in many instances. Cassie Scherer of Dublin-based Medtronic plc, told attendees at this year’s Food and Drug Law Institute annual conference that they should have a product change control protocol ready to go despite the absence of FDA guidance on the subject, an effort that will increase time to market but pay eventually big dividends. Read More
Medical device and analytics company Trajan Group Holdings Ltd. completed an AU$29.7 million (US$20.7 million) placement to fund the acquisition of Louisville, Kentucky-based Chromatography Research Supplies Inc. Read More
Onward Medical NV reported initial patient enrollment in its Hemon early feasibility study and first-in-human trial of its ARC implantable pulse generator. The study will examine stabilization of hemodynamic function in patients with a spinal cord injury. It is taking place at Lausanne University Hospital (CHUV). “Implanting into a human for the first time is an important step forward for our neurostimulation technology, designed to help refine and implement epidural stimulation therapy in patients with spinal cord injury,” Dave Marver, CEO of Onward, told BioWorld.Read More
The U.S. FDA had previously recommended that power morcellation be conducted only with tissue containment systems and has released a draft guidance for non-clinical testing for these containment systems. While the demands for non-clinical testing are rigorous, the draft also said that clinical testing is likely to be required as well, raising the question of why the agency failed to include clinical testing recommendations in the same draft guidance. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aifred, Assistek, Bioresource Technology, B dot Medical, Fluent Biosciences, Medix Biochemica, Nanocellect Biomedical, Strados Labs, Telecure. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Sonivie. Read More
