Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Brainsway, Continuity Biosciences, Heartsciences, Highridge, Livanova, Myriad, Zimvie.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Mindset Medical.
South Korea’s pharmaceutical exports rose nearly 18% year-on-year to reach $2.56 billion in the first quarter (Q1) this year, according to the Korea Health Industry Development Institute. Medical device exports, however, dropped about 5% in Q1 2025 to $1.39 billion, attributed to a drop in trade of implant products to both China and the U.S.
Vantive Health LLC, formerly the kidney care business of Baxter International Inc., plans to invest $1 billion over the next five years in development of digitally enabled dialysis products, innovation in acute organ support therapy options and expanding production capacity.
Amber Implants BV reported no device-related adverse events were seen in any of the patients fitted with its Vcfix spinal system, which treats vertebral compression fractures, at one-year. Data from the first-in-human trial of the device also showed patients experienced a significant reduction in their pain levels.
The U.K. National Institute for Health and Care Excellence reported it will streamline its health technology assessment, but the bigger news might be that the agency will no longer require new technologies prove to be cost saving to win an endorsement from the agency.
The U.S. FDA reported the launch of its in-house generative AI (GenAI) tool, dubbed Elsa, for a variety of purposes. FDA commissioner Marty Makary assuaged industry’s privacy concerns by promising that the algorithm does not train on data submitted by makers of devices and pharmaceuticals.
A research team led by consultant and orthopedic surgeon Glen Liau Zi Qiang from Alexandra Hospital in Singapore developed a new AI algorithm to improve the accuracy and efficiency of robotic total knee arthroplasty (rTKA) surgery.