MY01 Inc. Receives FDA Clearance for the MY01 Continuous Compartment Pressure Monitor as an Aid in Diagnosis of Compartment Syndrome

WASHINGTON, D.C.—AdvaMed, the medtech association, today announced a town hall featuring FDA Center for Devices and Radiological Health (CDRH) Director Michelle Tarver and fellow CDRH senior leaders at The MedTech Conference hosted by AdvaMed in San Diego in October. The town hall participants will update the audience on the center’s strategic direction and priorities and take questions.

Christopher L. White, Esq., AdvaMed’s General Counsel & Chief Policy Officer, on why this year’s legal, compliance & regulatory programming is mission-critical as medtech leaders navigate uncertainty, shifting enforcement priorities, and a rapidly changing global legal landscape.

DeChane Dorsey, Executive Director of AdvaMed Accel and a  leading voice for early-stage innovation, to explore why this year’s programming is especially critical for small companies and entrepreneurs.

WASHINGTON, D.C.—AdvaMed, the Medtech Association, is among 67 stakeholder groups, including patient advocacy groups and state medtech and life sciences associations, urging the Centers for Medicare and Medicaid Services (CMS) to create a timely, streamlined pathway for Medicare patients to access FDA-authorized breakthrough medical technology. 

WASHINGTON, D.C.—AdvaMed, the medtech association, today welcomed the kickoff of the latest Medical Device User Fee Amendments (MDUFA) discussion at a public meeting at FDA headquarters. Three AdvaMed senior staff members encouraged the agency to build on the successes of the prior five such agreements to ensure the next agreement, MDUFA VI, delivers strong results for the American public.

WASHINGTON, D.C.—Scott Whitaker, president and CEO of AdvaMed, the medtech association, made the following comment on the collaboration between Revival Healthcare Capital and Olympus Corporation to co-found Swan EndoSurgical, Inc. to develop a robotics platform to provide earlier, safer, and more effective treatment of lesions or tumors in the gastrointestinal tract relative to current therapeutic options. 

Join cyber experts for the Cybersecurity Summit that will address the latest industry issues and changes related to FDA requirements.

AdvaMed President and CEO Scott Whitaker testified before the U.S. Senate Finance Committee, bringing attention to the pressing issue of how tariffs could impact the medtech industry and, most importantly, the patients who depend on it.