Third-Party Hardware Modification of Interventional X-Ray Equipment

AdvaMed, the Medtech Association, recently published a technical white paper outlining concerns with third-party modification of interventional X-ray equipment, which can pose unforeseen risks for patients and providers.

AdvaMed, the Medtech Association, called on Medicare in a letter sent Friday to cover supplemental imaging for women with heterogeneously and extremely dense breast tissue, noting the life-saving value of the additional screening and the pressing health equity needs Medicare coverage of these critical services would address.   

AdvaMed, the Medtech Association, announced today that it has received accreditation from the premier American National Standards Institute (ANSI) to develop industry standards for medical device innovation. As an ANSI-accredited organization, AdvaMed will begin by developing standards for medical imaging technologies, including applications important to all of medtech, such as cyber security and artificial intelligence.

Years ago, my life was turned upside-down by an essential tremor, which caused my hand to shake so
severely that I had to leave my career as a nurse practitioner with the Department of Veterans Affairs.

In July, five patient leaders traveled to Capitol Hill to share their personal stories and speak to their lawmakers about the need to expand access to artificial intelligence technologies for medical imaging. The fly-in was held by Right Scan Right Time, a patient platform supported by AdvaMed Imaging.

AdvaMed recently hosted an “AI Demo Day” on Capitol Hill, where a number of medical imaging innovators had the opportunity to showcase some of the latest artificial intelligence (AI) technologies to members of Congress and their staff.

The recent House Departments of Labor and Health and Human Services Appropriations report has important news highlighting continued momentum in Congress to improve patient access to innovative medical imaging technologies and evidencing that AdvaMed’s messaging and advocacy initiatives are resonating in Congress.

This week, AdvaMed, the Medtech Association, applauded a bipartisan group of Senators for urging the Centers for Medicare & Medicaid Services (CMS) to develop a formalized payment pathway for algorithm-based health care services (ABHS) in the upcoming Hospital Outpatient Prospective Payment Systems (HOPPS) rulemaking cycle. ABHS are FDA-cleared medical devices that rely on artificial intelligence (AI) and machine learning (ML) to produce clinical information to aid in patient diagnosis or treatment.