Imperative Care Inc. received U.S. FDA 510(k) clearance for its Zoom Rdl radial access system for treatment of ischemic strokes. The device is designed to enhance radial access for removal of clots in patients with tortuous anatomy and other challenges to the femoral access typically used, providing more options for both patients and physicians. Read More
The European Commission (EC) has proposed to extend compliance deadlines under the Medical Device Regulation (MDR) to 2027 for high-risk devices and to 2028 for low- and moderate-risk devices, seemingly providing some critical breathing room for manufacturers and patients alike. However, the proposal requires that manufacturers have an application on file for their legacy device by May 2024, suggesting that manufacturers will still face a crippling backlog in obtaining contracts with notified bodies to process these applications. Read More
The U.S. Department of Justice (DOJ) reported an indictment of three men alleged to have filed more than $100 million in genetic testing false claims directly or indirectly with the Medicare program. Two of the three defendants face as many as 65 years of incarceration if convicted, a clear sign that federal government agencies in the U.S. are more intent than ever on cracking down on fraud and abuse of federal health programs. Read More
The U.S. FDA has granted Datar Cancer Genetics Inc. a breakthrough device designation for Trinetra-Glio, a blood test to help in the diagnosis of brain tumors. Read More
Suzhou Singular Medical Co. Ltd. has raised “hundreds of millions of RMB” in a series B+ round financing, which was jointly led by SDIC Chuanghe Fund Management Co. Ltd. and Qiming Venture Capital Management (Beijing) Co. Ltd. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: BD, Cardiacsense, Certest Biotec, Lydus Medical, Opticyte, Vero. Read More
