For about one-third of stroke patients, the cause of their cerebrovascular accident (CVA) is unknown at the time of hospitalization, but crucial to determine to prevent subsequent strokes. Electrocardiogram (ECG) monitoring in the 24 to 48 hours after a stroke detects atrial fibrillation (AF) in about 5% of patients. Remote monitoring with a noninvasive device detects far more cases and provides the opportunity to quickly head off secondary strokes, preserving lives and reducing costs of care, according to a study published by Royal Philips NV researchers. Read More
Disagreement over offsets for an additional $15.6 billion in COVID-19 funding forced the supplemental pandemic funds recently requested by the White House to be cut from the fiscal 2022 spending bill, so the U.S. House would have the votes to pass the $1.5 trillion omnibus spending package late March 9. Read More
Musculoskeletal (MSK) care company Sword Health Inc. has released a new digital therapy focused on pelvic pain and postpartum recovery. The Bloom sensor tracks and measures the pressure of the pelvic floor, with real-time feedback provided via an app. The technology then combines with clinical guidance from pelvic health specialists to help women create personalized exercise programs. Read More
The U.S. FDA has issued an advisory regarding vulnerabilities identified in the Axeda line of remote access software published by PTC Inc., which may affect more than 100 products made by dozens of manufacturers. The vulnerability could allow a hacker to trigger changes in the operation of the affected devices, a massive risk to patients undergoing medical imaging and radiotherapy procedures. The FDA notice stated that the Axeda Agent and desktop server programs are the subject of a notice by the Cybersecurity & Infrastructure Security Agency (CISA), which characterizes the vulnerability as requiring only a low-complexity attack to exploit. Read More
Med-tech startups looking to enter the South Korean market might do so with the 2021 Global Inbound Membership Bridge to Korea, or B2K 2021 program, run by Shinhan Financial Group Co. Ltd.’s Shinhan Square Bridge Incheon. The organization fosters startups with business scale-up services, new market development, partnering and investment assistance. Six med-tech and digital health firms were selected in November 2021: Aevice Health Pte. Ltd., Fairphonic Pte. Ltd., NDR Medical Technology Pte. Ltd., Scanderm Pro LLC, Sqin and Vertliner Private Co. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Insightec, Neurologica. Read More
