Day Zero Diagnostics Inc. added more of the right kind of zeros to its coffers as it closed a $16 million financing round supported by existing investors. Venture capital investment in the diagnostics company to date totals $49 million, with more than $18 million in additional non-dilutive funding. The company is developing a diagnostic that provides same-day identification of an infectious pathogen and its antimicrobial susceptibility profile.
The U.S. FDA is still sorting through the feedback for its proposal to modestly align the Quality System Regulation with ISO 13485, but the agency has posted a draft four-year plan for regulatory harmonization that is substantially broader in scope than just quality management system considerations. While this proposal addresses a significant need for device makers working in multiple markets, the objectives include an assessment of at least nine non-FDA harmonization proposals by the end of fiscal year 2025, a clear indicator that harmonization will continue to be every bit the slog it has proven to be in recent years.
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.
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