Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Flume Catheter.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Ancora Heart, Baxter, Edwards Lifesciences, Masimo, Medtronic, Seastar Medical.
It has long been known that patients recover more quickly from transcatheter aortic valve replacement (TAVR) than from open-heart surgery for valve replacement (SAVR) and results at two years looked good, too, with very similar outcomes. The question remained what happens in the longer term?
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has approved Telix Pharmaceuticals Ltd.’s lead prostate cancer imaging agent, Illuccix. Illuccix (TLX591-CDx) is a Gallium-based PSMA imaging agent and cold kit for developing radiopharmaceutical products and diagnostic agents. Telix’s prostate cancer program consists of a companion diagnostic imaging agent (TLX591-CDx) and a therapeutic (TLX-591) to improve the detection and treatment of prostate cancer.
Beijing Airdoc Technology Co. Ltd. raised HK$1.67 billion (US$214.8 million) with its IPO on the Hong Kong Exchange (HKEX) on Nov. 5, falling below its expectations of a $500 million raise. Share prices for the artificial intelligence-based (AI) medical imaging firm were priced at HK$75.10 apiece and dropped 3.5% to HK$72.50.
A new study has found that despite the risk, many patients are open to interventional procedures such as renal denervation (RDN) if it can lead to improved blood pressure. RDN is performed under local anesthetic and uses radio frequency ablation to burn the nerves in the renal arteries. The process causes a reduction in nerve activity, which decreases blood pressure.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Rewalk Robotics.