Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 3B Pharmaceuticals 10x Genomics Inc, Icecure, Nanostring, Pi-Cardia, Reflexion, Tivic.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Carlsmed, Choicespine.
The latest patent application from Neuroderm Ltd. described a magnetic coupling and detection mechanism for its small two-part wearable infusion drug delivery device that delivers a liquid drug to Parkinson’s disease patients subcutaneously.
The U.S. FDA’s Accreditation Scheme for Conformity Assessment (ASCA) program is one of a number of efforts on the agency’s part to reduce the drag on premarket medical device submissions, but the agency has now converted the ASCA pilot into a full-blown regulatory program. Fortunately for both the FDA and industry, most of the guidance groundwork is already in place, making the ASCA program a ready-to-go method for streamlining at least one element of premarket applications for medical devices.
A Sept. 21 U.S. FDA advisory committee meeting will either be a “Hail Mary” or a last gasp of life for ITCA-650, a twice-yearly implantable exenatide-device combination product intended to improve glycemic control in adults with type 2 diabetes.
Before the Wall Street opening bell on Tuesday, Boston Scientific Corp. reported plans to acquire privately held Relievant Medsystems Inc. for $850 million in cash at closing plus undisclosed payments contingent on sales performance of the company’s lead product, the Intracept intraosseous nerve ablation system, over the next three years.
Israeli startup Briya Ltd. raised $11.5 million in series A financing which will support the expansion of its health care data exchange platform across Europe and the U.S. The round was led by Team8, and included existing investors Insight Partners, and Amiti Ventures, and was joined by the George Kaiser Family Foundation.
The U.S. Centers for Medicare & Medicaid Services (CMS) is once again in the crosshairs thanks to issues related to pharmacy benefits managers and coverage of novel medical devices, with Congress mulling over two dozen pieces of Medicare-related legislation.
Developers of combination products face an unusual dilemma in their interactions with the U.S. FDA, given that the data for the constituent products reside in multiple product centers. Some of the related clunkiness may soon be a thing of the past thanks to a new four-year proposal to overhaul the FDA’s information technology infrastructure, which among other things will emphasize a more seamless sharing of data across centers, precisely the kind of initiative that would facilitate reviews of combination products.
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