Infervision Medical Technology Co. Ltd. received approval from China’s NMPA for its radiological computer-assisted triage and notification software device Inferread CT Stroke. This is the first class III approval that the firm obtained in the cerebro-cardiovascular field. Class III approvals are for high-risk medical devices.
The U.S. FDA has given Sonalasense Inc. a green light to conduct two clinical trials in life-threatening brain tumors using sonodynamic therapy (SDT) and SONALA-001, an intravenous proprietary formulation of 5-aminolevulinic acid, or ALA. The studies – in diffuse intrinsic pontine glioma (DIPG) and recurrent glioblastoma (rGBM) – mark the first time SDT will have been used in clinical trials.
The U.S. FDA’s two-day meeting of the patient engagement advisory committee (PEAC) covered a range of issues surrounding augmented reality (AR) and virtual reality (VR) products, but patient information and education was one of the key considerations. Naiem Nassiri of Yale Medicine cautioned, however, that a 15-minute briefing between doctor and patient during a face-to-face encounter would likely create more confusion than clarity, a conclusion that would suggest that other patient education methods will likely be needed.
Medtronic plc has entered a strategic collaboration with Cathworks Ltd. to expand the reach of Cathworks’ artificial intelligence (AI) guidance system for coronary artery disease management. Medtronic will invest up to $75 million and immediately begin co-promotion of the Ffrangio system on the U.S., European and Japanese market. As part of a separate agreement, Dublin-headquartered Medtronic will have the option to acquire Cathworks once certain undisclosed milestones are met.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alpheus, Bone Solutions, Venus Medtech.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adaptix, Limacorporate, Orthofix, Orthox, Oxford Tech, Sonivie.
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