Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medtronic, Microvention.
Researchers at Singapore’s Agency for Science Technology & Research Bioprocessing Technology Institute (also known as A*STAR BTI) saw publication of their patent application for a wearable electronic system for solid-state epidermal biomarkers (SEB) that enables in situ, continuous, multiplexed, wireless, and skin-integrated sensing of analytes such as cholesterol, lactate, and glucose.
The U.S. FDA is going straight to final guidance with its “Considerations for the conduct of clinical trials of medical products during major disruptions due to disasters and public health emergencies [PHEs].”
The U.S. FDA is going straight to final guidance with its “Considerations for the conduct of clinical trials of medical products during major disruptions due to disasters and public health emergencies [PHEs].”
CMR Surgical Ltd. raised $165 million in financing from its existing investors that will allow the company to continue to innovate its portable robotic surgery system, Versius, and grow its position in existing and new markets. The latest financing takes CMR’s total capital raised since its founding to over $1 billion. The Versius surgical robotic system is now in over 20 markets and the company has become the second largest soft tissue surgical robotics company globally, after Intuitive Surgical Inc.
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.
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