Guardant Health’s Shield™ Blood Test Approved by FDA as a Primary Screening Option, Clearing Path for Medicare Reimbursement and a New Era of Colorectal Cancer Screening

AdvaMed’s® Comment Letter to ASTP/ONC, outlines concrete policy reforms across FDA oversight, CMS payment pathways, and HIPAA data-sharing rules to accelerate patient access to AI-enabled medical technologies. As AI-enabled medical devices transform patient care, outdated regulatory, coverage, and privacy frameworks are slowing the pace of adoption.

PALO ALTO, Calif., Feb. 11, 2026 i-GENTIC AI today announced a new suite of context-aware, multilingual MedTech agents designed to help medical device manufacturers improve the quality and consistency of FDA 510(k) submissions. Preparing a 510(k) often takes months, yet many submissions require additional information requests or are rejected due to inconsistencies across documents, evidence, and claims, creating delays and added costs for manufacturers.

Explore AdvaMed’s Medical Device Submissions Workshop Series from practical submission strategies to live expert insights you can apply immediately.

WASHINGTON—AdvaMed, the MedTech Association®, today announced Melissa Torres is the new Executive Vice President of Technology and Regulatory Affairs. Torres succeeds Janet Trunzo, who retired after 30 distinguished, productive years withAdvaMed®. 

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).

After 30 years atAdvaMed®, 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.

Gain in-depth IDE submission training, meaningful face time with FDA and regulatory leaders, and RAPS accreditation credits at AdvaMed’s IDE Submissions Workshop.

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.