The Medical Device Manufacturers Association (MDMA) has elected Outset Medical Chair and CEO Leslie Trigg as chair of the trade group’s board of directors. MDMA announced the leadership change today, following the Washington, D.C.-based industry association’s annual meeting last week. “Medical technology innovators are at the forefront of improving patient outcomes and reducing the cost […]
MDMA
Medtech gets behind breakthrough device law for seniors
Congressional Democrats and Republicans today introduced a bill to provide Medicare coverage for devices granted FDA breakthrough designation. Sponsored by U.S. Reps. Suzan DelBene (D-Wash.), Jackie Walorski (R-Ind.), Tony Cárdenas (D-Calif.), Gus Bilirakis (R-Fla.), Terri Sewell (D-Ala.) and Fred Upton (R-Mich.), the Ensuring Patient Access to Critical Breakthrough Products Act would codify an effort that […]
Fifth round of medtech user fee talks set to begin soon
Every five years, the FDA, the medtech industry and the public sit down and hammer out how the agency should spend the money it collects in fees from medical device developers seeking approvals and clearances. The agency also uses the Medical Device User Fee Amendment (MDUFA) to set fees for biologics license applications, 513(g) requests for information and de […]
The 10 most popular DeviceTalks Weekly Podcast episodes of 2020
Without the ability to gather for events and meetings, the DeviceTalks team launched the DeviceTalks Weekly Podcast to keep our medtech community talking. Over the span of 9 months and 39 episodes, we interviewed dozens of medtech leaders from startups to multinational corporations to hear how they’re managing through the challenges of 2020. Our episodes […]