Early-stage breast cancer patients in the U.S. may soon be able to access another treatment regime based on the result of a Nov. 7 FDA advisory committee for the Prosense cryoablation system by Icecure Medical Ltd. The advisory committee voted 9-5 that the benefits of Prosense outweigh the risks, although the FDA has yet to decide on the application. Read More
Zap Surgical Systems Inc. reported closing a $78 million series E funding round led by Qingdao Baheal Medical Inc., with participation from other strategic investors. The new funds will be used to commercialize the company’s Zap-X gyroscopic radiosurgery platform for the non-invasive treatment of brain tumors. Read More
Hyperfine Inc. gained CE mark approval for the latest generation of its artificial intelligence-powered software for its Swoop portable magnetic resonance imaging system, under the European Medical Device Regulation. Read More
Radiopharmaceutical biotech and contract development and organization firm Duchembio Co. Ltd. filed a securities report to South Korea’s Financial Services Commission Nov. 11, kickstarting the IPO process to list on the Korea Exchange. Read More
The U.S. Government Accountability Office has rejected an appeal by MCI Diagnostics Inc. regarding a contract bid with the Department of Veterans Affairs despite the company’s assertion that the VA pricing mechanism is flawed. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aethlon Medical, Deephealth, GE Healthcare, Geo-Med, Radnet, Trisalus. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Momentis. Read More
