FDA Grants Breakthrough Device Status to Healthcare AI Software

December 05, 2018 - The FDA has granted breakthrough device designation to healthcare AI software being developed by Bayer and Merck for chronic thromboembolic pulmonary hypertension (CTEPH) pattern recognition.

The software will rely on deep learning to support radiologists in identifying CTEPH in computed tomography pulmonary angiography (CTPA) scans, explained Bayer in a press release. CTPA and ventilation/perfusion scan are common diagnostic methods used to detect CTEPH.

The software processes image findings of cardiovascular, lung perfusion and pulmonary vessel analysis with the patient’s history of pulmonary embolism.

“Bayer is looking forward to leveraging our expertise in Radiology to develop a software to support radiologists and treating physicians in the complex diagnostic decision making process of this rare disease,” said Prof. Dr. Olaf Weber, Head of Radiology Research & Development of Bayer AG’s Pharmaceuticals Division. “We hope that greater awareness of CTEPH in conjunction with a decision-support tool will eventually assist in diagnosing patients earlier and more reliably, thereby allowing earlier treatment.”

CTEPH is a rare form of pulmonary hypertension disease that only affects between eight and 40 people per million globally. It can be difficult to diagnose because its symptoms are similar to other lung diseases and there is a lack of clinical awareness about CTEPH.

The FDA explained that the breakthrough device program is “intended to help patients have more timely access to devices and breakthrough technologies that provide for more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases, for which no approved or cleared treatment exists or that offer significant advantages over existing approved or cleared alternatives.”

The breakthrough device program, which was required by the 21st Century Cures Act, expands on the FDA’s expedited access pathways (EAP) program by making devices approved through the 510(k) pathway eligible as well as premarket approval applications and de novo device submissions. All companies previously granted EAP designation will have designation as breakthrough devices.

The FDA recently said it is updating its voluntary 510(k) approval process, which dates from 1976, to address growing medical device connectivity and new technologies.

Under the 510(k) pathway, device manufacturers use comparative testing against predicate devices—devices already on the market—to show that a new device is as safe and effective as the predicate device.

The 510(k) pathway is the most commonly used premarket review process. In 2017, the FDA cleared 3,173 devices through the pathway, or 82 percent of all devices cleared or approved.

Close to 20 percent of current 510(k) approvals are based on predicate devices that are more than 10 years old, a process that could be holding back medical device innovation, the FDA noted.

The agency is considering publicizing devices or manufacturers who make technologies that rely on predicates that are more than 10 years old. It is also weighing whether other factors should be added to its point of reference and whether there are actions it should take to push the use of more modern predicates.

“We believe that encouraging product developers to use more modern predicates would give patients and their doctors a choice among older and newer versions of a type of device, promote greater competition to adopt modern features that improve safety and performance, and help make sure that newer devices reflect more modern technology and standards that can improve patient care and outcomes,” the agency said.

In early 2019, the agency plans to finalize guidance for alternative 510(k) pathway that permits device makers of “certain well-understood device types to rely on objective safety and performance criteria to demonstrate substantial equivalence as a way to make it more efficient to adopt modern criteria as the basis for the predicates that are used to support new products.”

The FDA’s efforts to revise the 510(k) pathway complements its National Evaluation System for Health Technology (NEST) initiative, which is intended to generate evidence across the total product lifecycle of medical devices by applying advanced data analytics.

The 510(k) update and NEST initiatives are part of the agency’s broader Medical Device Safety Action Plan to improve medical device security across the board, with the goal of “ensuring that the FDA is consistently first among the world’s regulatory agencies to identify and act upon safety signals related to medical devices.”