Tracking rapid growth of AI/ML medical devices in 5 charts

There is a quiet revolution taking place in the medical devices industry. Artificial Intelligence and Machine Learning (AI/ML) technologies are driving rapid innovation across a broad range of medical applications.

As of August 7, 2024, FDA has authorized a total of 950 AI/ML enabled medical devices. Considering that there were fewer than 50 medical devices using AI/ML based medical devices prior to 2016, the rate of growth over the last few years has been impressive!

FDA approved the first AI/ML device in 1995, but the pace began accelerating only after 2016.

There is a lot of buzz about AI these days, but did you know that the FDA approved the first AI/ML enabled medical device in 1995? It was an AI-enabled cervical smear rescreening device for rapid screening with better sensitivity. Since then, there has been rapid innovation in this space.

AI/ML device marketing authorizations grew at a CAGR (compounded annual growth rate) of 49% between 2016 and 2023 as shown in the Figure below. There were a total of 843 AI/ML medical devices by the end of 2023, reflecting a nearly 40% growth compared to prior year. At the current rate, the cumulative total of over 1100 AI/ML medical devices are projected to be authorized by the end of 2024.

Radiology continues to dominate the category, but Cardiovascular applications are growing fast.

Radiology continues to be the dominant category for AI/ML enabled innovation, accounting for 76% of devices authorized as shown below. Other top medical specialties are: Cardiology (6%), Neurology (4%), Hematology (2%) and Gastroenterology-Urology (1%). All other medical specialties account of the remaining 7% of the authorized devices using AI/ML.

There has been a noticeable growth in Cardiovascular applications since 2015 as shown in Figure 3 below. The first AI/ML device for a cardiovascular application was cleared in 2015. Since then, the category has grown at a CAGR of 75% between 2016 and 2023, to reach a total of 98 AI/ML devices authorized by August 2024.

AI/ML applications span across a broad range of medical devices.

Just as diverse medical devices are in their intended use applications, so are AI/ML enabled devices in their applications across different medical specialties.

As shown in Figure 4, top 3 AI/ML device codes in Radiology, Cardiovascular and Neurology specialties span a broad range of medical applications, ranging from radiological image processing to blood flow visualization to monitoring brain activity. In nearly all cases, these devices are used to assist in diagnosing a medically significant condition or planning an appropriate medical treatment for a specific patient.

Novel applications without a predicate device are growing fast.

A vast majority of the AI/ML devices (97%; 924/950) have been cleared through the 510k premarket notification pathway. Only 4 required a PMA and 22 were reclassified as Class II through the De Novo pathway.

As shown in Figure 5, Cardiovascular, Radiology and Neurology medical specialties collectively accounted for 68% of the De Novo reclassifications (15/22) granted for AI/ML devices from 2013-2024 YTD.

A total of 7 De Novo were granted in 2021, the most in any single year, with 4 in the Cardiovascular specialty alone. Among these 4 was the breakthrough Feops HEART guide (DEN 200030), an interventional cardiovascular implant simulation software.

In the same year, another innovative AI/ML enabled device to aid in the detection of pediatric autism spectrum disorder (ASD) received marketing authorization through the De Novo pathway.

Although not yet high in volume, these novel AI/ML enabled devices highlight the future of this technology in assisting with diagnosis and treatment of challenging medical conditions.

In conclusion

The future of AI/ML applications in the medical device industry is bright!

These technologies are helping physicians and patients find new ways to manage challenging medical conditions. Medical device innovation has been rapidly increasing since 2016, with a total of 950 AI/ML devices receiving FDA approval through August 2024.

But these numbers don’t tell the whole story. At a high level, Radiology specialty dominates the number of AI/ML devices approved, but novel devices in the Cardiovascular and Neurology specialty are on the rise. Once approved, some of these novel devices are also fueling rapid growth by serving as predicates for other similar devices that can get to market through a less stringent 510k regulatory pathway.

This is good news for physicians and patients.

Like this article? Click here to unlock exclusive subscriber-only content.