American College of Radiology partners with FDA to hasten availability of AI products
The U.S. Food and Drug Administration is partnering with the American College of Radiology to help hasten the availability of new AI products and other devices in the specialty.
This fall, the FDA launched the expansion of its Total Product Life Cycle Advisory Program, also referred to as “TAP.” The administration first initiated the pilot in 2023 to spur faster development of high-quality medical devices in cardiology and neurology. Now, the agency is broadening the effort into radiology and ophthalmology amid early success in the original specialties.
As part of the process, the feds are seeking greater communication between the manufacturers of breakthrough devices and physician professional societies such as the ACR. Payers, patient advocates and others also are participating in the process.
“The goal of the collaboration is to increase access for radiologists and their patients to safe, effective and clinically meaningful radiology device innovations,” ACR said in a Friday news update. This will include (but is not limited to) “AI-enabled software devices and other cutting-edge technologies.”
In assessing new devices, the radiology TAP will focus on engaging patients, developing clinical evidence, adopting technology into clinical practice, and calculating reimbursement.
The FDA first announced the pilot’s expansion into radiology and ophthalmology in July, with orthopedic devices joining in the next phase (January 2025). Thus far, TAP has enrolled 46 breakthrough devices in cardiology, neurology and physical medicine, with all meeting related Medical Device User Fee Amendments goals, the FDA noted in an announcement.
“[The Center for Devices and Radiological Health] is excited to continue expanding TAP to cover innovators and devices in new clinical areas,” the agency added.
ACR and other advisors will serve as “innovation ambassadors” in radiology. They’ll help to identify sources that may provide input on a “holistic value proposition that may inform improved strategic decision-making during product development across the med-tech ecosystem.” Other TAP advisors across all specialties include the Michael J. Fox Foundation for Parkinson's Research, the Society of Thoracic Surgeons, the American Medical Association, and the National Organization for Rare Diseases.
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.