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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

Sep. 20, 2023

View Archived Issues
CMRs Versius robotic surgery system

CMR Surgical rakes in $165M to hit $1B in funding

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. Read More
A technician preparing to run microbial genomes on the Roche 454 sequencing platform at the Advanced Technology Research Facility.

A good day for Day Zero with new $16M financing

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. Read More
Laptop displaying FDA logo

Med-tech harmonization plan is a study in regulatory incrementalism

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. Read More

US FDA advises sponsors on conducting trials in the face of disasters, 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].” Read More
Magnifying glass, FDA concept image

FDA converts conformity assessment pilot into a full-fledged program

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. Read More
Neuroderm pump

Patent update: Neuroderm improves the design for its wearable anti-Parkinson’s infusion pump

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. Read More

Appointments and advancements for Sept. 20, 2023

New hires and promotions in the med-tech industry, including: Bone Health, Rewalk, Teladoc. Read More

Financings for Sept. 20, 2023

Med-tech firms raising money in public or private financings, including: Rayzebio, Vivante Health. Read More

Other news to note for Sept. 20, 2023

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. Read More

Regulatory actions for Sept. 20, 2023

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Carlsmed, Choicespine. Read More

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