The U.S. FDA has granted premarket approval for Transmedics Group Inc.’s OCS heart system for use with organs from donors after circulatory death (DCD). The approval expands on a prior FDA approval of the device for use with organs from donors after brain death in September 2021. Andover, Mass.-based Transmedics said its system can now be used for ex vivo reanimation, functional monitoring, and beating-heart preservation of donation-after-circulatory-death hearts. Read More
The NMPA approved two different surgical robots for marketing, a step forward in growth of a sector that remains underdeveloped in China. One of the robots approved for marketing by the NMPA is from Yuanhua Orthopedic Robotic Ltd. and the other is Suzhou Microport Orthobot Co. Ltd. Both robots are used for total knee arthroplasty (TKA), removing damaged cartilage and bones from the surface of the knee joint and replacing them with artificial implants. Read More
Canada’s federally-funded Digital Technology Supercluster is joining with industry to invest CA$17.8 million (US$13.9 million) in an artificial intelligence (AI)-powered technologies program to advance personalized treatment for patients with cancer. Read More
The Spanish National Research Council, CSIC, has just been awarded funding from the European Research Council to establish proof of concept for new type of flat-plate positron emission tomography scanner (PET) that can be attached to the patient’s body to accurately monitor cancer proton therapy results in real time. Read More
Not satisfied with the findings of a World Trade Organization (WTO) dispute panel, Turkey informed the WTO April 28 that it has initiated arbitration proceedings to review those findings, which involve an EU complaint about measures Turkey employs concerning the production, importation and marketing of prescription drugs. Read More
Med-tech firms raising money in public or private financings, including: Adona Medical, Creative Medical Technology, Ictero Medical, Royal Phillips. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biosense, Caredx, Extremity Medical, Fusion Orthopedics, GE Healthcare, Lumiata, Medtronic, Rewalk, Somatus, Stevanato. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Clearpoint Neuro, Venus Concept. Read More
