The Biden administration has floated a budget proposal for fiscal year 2023, which includes $49 billion for the National Institutes of Health (NIH) and an additional FDA budget authority of $356 million over the current fiscal year. However, the budget also includes legislative proposals, such as a virtual inspection requirement for device manufacturing facilities and compulsory studies of drug shelf life to evaluate finished drug stability beyond the labeled expiration. Read More
Medtronic plc reported its tibial neuromodulation device was implanted in the first patient with overactive bladder as part of its Titan 2 pivotal study. The device stimulates the posterior tibial nerve near the ankle to assist in regulation of bladder function. Medtronic expects to enroll 130 patients in the study. Read More
U.K. health tech startup Sano Genetics Ltd. landed $11 million to develop a genetic data-sharing platform that connects patients with clinical researchers. MMC Ventures led the series A funding round, with Episode 1, Seedcamp and other individual investors participating. Read More
Shenzhen Xzing Technology Co. Ltd.’s Endofresh disposable upper gastrointestinal (GI) endoscope has granted the NMPA’s class II approval. The company said the approved product is used for upper gastrointestinal GI endoscopy, diagnosis and treatment. Read More
The European Commission has acted to thwart cybersecurity risks with a proposed cybersecurity regulation and separate proposal for information security. What is not clear, however, from these proposals is whether they would interact with existing EU rules governing cybersecurity for medical devices, raising the prospect that medical technologies will be subject duplicate oversight for cybersecurity.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Dexcom, Diality, GE Healthcare, Mir Scientific, Paramit, Theralink, Tractus Vascular. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biobeat, Staar Surgical. Read More
