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.
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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Masimo, Medtronic.
The U.S. FTC’s policing of Orange Book patent listings begs the question of when, and whether, the FDA will deliver on its commitment to provide more clarity on the types of device patents that can be listed as covering a “drug product.”
One-year data from Xeltis AG’s first-in-human Axess vascular conduit trial showed outstanding results in patients with end stage renal disease who were deemed unsuitable for arteriovenous (AV) fistula creation. The results, presented at the VEITHsymposium in New York, showed 100% secondary patency, 78% primary assisted patency and no infections were observed in data from 20 patients implanted with the Axess conduit.
The medical device industry might at times believe that it is the sole focus of the U.S. federal government thinking about cybersecurity, but the FDA is hardly alone in leaning hard on industry to stand up a solid cybersecurity regime. The Securities and Exchange Commission (SEC) is also turning the screws on corporate America regarding cybersecurity as seen in enforcement against Solarwinds Corp., an enforcement action that Seth Carmody of Medcrypt Inc., said highlights the breadth of regulatory hazards for the med-tech industry.
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