MY01 Inc. Receives FDA Clearance for the MY01 Continuous Compartment Pressure Monitor as an Aid in Diagnosis of Compartment Syndrome
- MY01
MONTREAL, May 6, 2021 /PRNewswire/ – MY01’s device helps diagnose acute compartment syndrome (ACS), a relatively common and potentially lethal muscle condition notably suffered by Tiger Woods in his car accident last February. Because current diagnostic tools rely on a patient’s inherently subjective pain description, ACS diagnosis is often misdiagnosed or missed entirely and is the main cause of lost lawsuits against orthopedic surgeons in the U.S. Read more…
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News / Diagnostics / Digital Health / Medical Imaging / Regulatory Affairs
AdvaMed Receives RAPS Accreditation for Medical Device Submissions Workshop Series (February 2026 in Washington, D.C.)
February 4, 2026
WASHINGTON, D.C.—AdvaMed, the world’s largest trade association representing medical technology innovators, announced that its Medical Device Submissions Workshop Series (February 23-27 in Washington, D.C.) has been officially approved for RAC recertification credits by the Regulatory Affairs Professionals Society (RAPS).
Blog / Diagnostics / Digital Health / Regulatory Affairs / Standards
Honoring Janet E. Trunzo: A Legacy That Shaped Modern Medtech Regulation
January 29, 2026
After 30 years at AdvaMed, Janet E. Trunzo, Senior Advisor to the President and Senior Executive Vice President of Technology and Regulatory Affairs, will retire on January 31, 2026. Her tenure has fundamentally shaped how medical devices are regulated in the United States and globally, establishing frameworks and standards that continue to govern the field today.
Blog / Regulatory Affairs
Strengthen Your IDE Strategy at AdvaMed’s IDE Submissions Workshop
January 27, 2026
Gain in-depth IDE submission training, meaningful face time with FDA and regulatory leaders, and RAPS accreditation credits at AdvaMed’s IDE Submissions Workshop.
News / Coverage & Payment / Diagnostics / Regulatory Affairs
AdvaMed Names Brian J. Blaser, QuidelOrtho President and CEO, Chair of AdvaMedDx Board of Directors
January 21, 2026
WASHINGTON, D.C.—AdvaMed, the Medtech Association, today announced that Brian Blaser, president and CEO of QuidelOrtho, will serve as the next chair of the AdvaMedDx Division Board of Directors, succeeding Thierry Bernard, CEO of QIAGEN. AdvaMedDx represents more than 70 manufacturers of the innovative in vitro diagnostic (IVD) tests critical to patient care.
News / Artificial Intelligence (AI) / Coverage & Payment / Diagnostics / Digital Health / Government & Legislative Affairs / Medical Imaging / Regulatory Affairs
Medical Imaging Division Announces Rich Fabian as New Board Chair
January 16, 2026
WASHINGTON, D.C.—AdvaMed, the Medtech Association, today announced that Rich Fabian, president and CEO of FUJIFILM Sonosite, will serve as the chair of the Medical Imaging division’s board of directors. He will succeed David Pacitti, CEO of Avanos Medical and former president and head of the Americas at Siemens Healthineers, the inaugural division board chair.
News / Artificial Intelligence (AI) / Coverage & Payment / Diagnostics / Digital Health / Government & Legislative Affairs / Orthopedic / Regulatory Affairs
Robert Cohen of Stryker Named Chair of AdvaMed’s Digital Health Tech Division Board of Directors
January 5, 2026
WASHINGTON, D.C.—AdvaMed, the Medtech Association, today announced that Robert Cohen, vice president, innovation and technology, orthopaedic group at Stryker, will be the next chair of the AdvaMed Digital Health Tech Board of Directors. He succeeds Dr. Taha Kass-Hout, global chief science and technology officer at GE HealthCare, who served as the inaugural chair of the board overseeing the then-newly created division.
Resource / Business Development
From Category to Capabilities: Rethinking Procurement Through the Business Lens
December 17, 2025
Read how shifting to a capability-driven procurement model enables medtech organizations to better align sourcing decisions with business strategy, and strengthen cross-functional collaboration.
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Mick Farrell, Chairman and CEO of Resmed, Named Chair of AdvaMed Board of Directors
December 11, 2025
WASHINGTON, D.C.—AdvaMed, the Medtech Association, today announced Michael “Mick” Farrell, chairman and CEO of Resmed Inc. (NYSE: RMD, ASX: RMD), the leading health technology company focused on sleep, breathing, and care delivered in the home, will be the next chair of the AdvaMed Board of Directors. Farrell will serve a two-year term beginning in January 2026.