The renal denervation hypothesis of hypertension was initially viewed with some skepticism, and Dublin-based Medtronic plc. endured a major setback when clinical trial data failed to make a compelling case for approval for the Symplicity Spyral. However, the company finally landed an FDA approval for the device, opening the gates to a new and significant market opportunity even with competition already on the market. Read More
Surmodics Inc. reported positive two-year data from the SWING trial, the first-in-human study to look at the safety of its Sundance Sirolimus drug-coated balloon (DCB) when used to treat occlusive disease of the infrapopliteal arteries. Results presented at the VEITHsymposium in New York showed that the Sundance Sirolimus DCB demonstrated an excellent safety profile and achieved primary patency of 71.4% at 24 months in the per protocol analysis population. Read More
South Korea’s Ministry of Food and Drug Safety (MFDS) will head an international team of regulatory experts from 19 drug agencies worldwide, including the U.S. FDA and China National Institute for Food and Drug Control (NIFDC), to draft an international standard for artificial intelligence (AI)-based software. Read More
Janet Woodcock, one of the longer-tenured U.S. FDA center directors in the agency’s history, is set to retire sometime in 2024, although the exact date has not been set. Read More
In what represents the first Patent Cooperation Treaty filing published in the name of London, U.K.-based Abtrace Ltd., the company’s co-founder and chief executive officer, Umar Naeem Ahmad, collaborates with Xavier Monnet – professor of intensive care at Assistance Publique - Hôpitaux de Paris (APHP) Université Paris-Saclay – on the design of a fluid delivery system for delivering intravenous fluid therapy to a patient. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Masimo, Medtronic. Read More
