Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Femasys, Illumina.
In the first study to compare transcatheter aortic valve replacement or implantation to surgical aortic valve replacement exclusively in women, Edwards Lifescience Corp.’s Sapien 3 and Sapien 3 Ultra valves provided better outcomes.
Asia Pacific is the fastest growing region for health care spending, and by 2030 APAC will account for more than 20% of global health care spending, Tom Lawry, managing director of Second Century Tech told the APACMed Forum 2024 conference held in Singapore, Sept 5-6.
Angiodynamics Inc. received CE mark approval for its Auryon atherectomy system which treats peripheral artery disease, including critical limb ischemia and in-stent restenosis. The regulatory clearance expands the company’s global reach as it sees increasing revenues from sales of the device.
The FDA reported several class I recalls in the first week of September 2024, a list that includes products such as Medtronic plc’s McGrath line of laryngoscopes, some of which should be jettisoned.
New hires and promotions in the med-tech industry, including: Clouds of Care, Cytotronics, Firefly Neurosciences, Fortive, Neuopace, Syntheticmr, Veracyte, Whiteswell, Zimmer Biomet.
Seoul, South Korea-based Neudive Inc. is advancing a game-like digital therapeutic called Buddy-in as a software solution for children and adolescents with autism spectrum disorder to practice and improve social skills.
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