An Insider's Perspective Into the FDA's AI/ML List for Healthcare Buyers Looking to Activate an AI Strategy

Refined Review of FDA AI/ML list provides clear view of top Healthcare AI Innovators: Aidoc Medical & Siemens Healthineers

As a busy healthcare provider, investor, or healthcare innovator, gaining insights to the impact of new, complex technologies like Artificial Intelligence to the medical device market can be difficult. To help demonstrate the diversity and velocity of innovation in medical device software, the FDA has developed and made accessible a valuable informational resource – the ““Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices”. The agency, on an ongoing basis, searches its summary decisions for medical device products that incorporate or make use of computational technologies that can be categorized under the broad umbrella of “Artificial Intelligence”. It is important to appreciate the nuances of the FDA’s regulatory process and the nature of software medical products, however, before making direct conclusions from the data. In other words, the data resource should not be a primary source of market and competitive insights.

Asher Orion Group has years of medical device development experience and knowledge of the market learned from conceiving, designing, bringing to market, and supporting the sale of analytical/ML, medical device software. We use that experience to develop an informed point of view (POV) about the landscape of regulated, AI/ML products and are happy to present the analysis “An Insider’s Perspective Into the FDA’s AI/ML List for Healthcare Buyers Looking to Activate an AI Strategy” [Link made public on 9/26/222].

Critical to developing this informed POV is first defining and clarifying the types of “artificial intelligence” as applied to medical devices and medical device software. Realize that for any product to be on the FDA list, it must either be part of a medical device system, or functions as a standalone device as defined by the US FD&C* Act. While there is a LOT of value and impact by incorporating AI/ML methods within medical devices, we posit that the broader, transformational potential of AI to medicine is best realized by products that make diagnostic decisions, assist physicians in making decisions, or that actuate a treatment or intervention based upon their abilities to derive insights from data. We, therefore, filter and analyze the ‘raw’ FDA listing with that distinction in mind. The filtered listing is in Table 1 within the article.

When assessing healthcare technology value, in general, quantity shouldn’t trump quality. Numerical rankings can be insightful, though, to build a more-informed picture of the innovation landscape. Informed by the criteria above, our analysis shows that the two vendors with the most cleared, AI/ML products that directly inform licensed medical professionals in the interpretation and processing of diagnostic, medical imaging are AiDoc and Siemens Healthineers.

AiDoc’s product strategy has been to focus on assisting the radiologist in prioritizing their work and to be reminded if a potentially, urgent finding may have been missed in their read. “There is no shortage of healthcare AI options, but significant gaps exist among them. You can have the best algorithm in the world, but if you can’t deliver data in a streamlined and actionable way, it won’t be effective,” said Elad Walach, co-founder and CEO of Aidoc. “The value of AI is unleashed through a strategic, scalable, and intelligent unified platform that empowers physician decision-making through real-time data. Our approach to innovation has married our AI engineering ability with real-world clinical requirements to develop a solution that provides actual and immediate value to both health systems and patients.”

Siemens Healthineers’ focus has been largely towards using the discriminatory and detection power of DL/ML methods in detecting and/or characterizing findings that may be secondary to the radiologist’s primary mission in reading a study. “One of the keys to our success in Artificial Intelligence is our focus on high-quality clinical data for algorithm development. Siemens Healthineers has built out specialized diagnostic reading teams that provide analytical expertise on a database of over 1.2 billion curated images, clinical data and specialized reports to assist in training the AI algorithms,” said Peter Shen, head of digital health for North America, Siemens Healthineers.

We hope this article is useful to the overburdened buyers in the imaging community either trying to understand the AI/ML landscape or whom are in the process of developing an activation strategy for their practice or health system. Asher Orion Group is happy to further this discussion and analysis with those buyers. Our goals are to help narrow-down the landscape, assess AI solutions relevant to your needs, assist in the optimal configuration of those solutions, and to monitor the performance and ROI of AI/ML innovations regardless of the manufacturer, integration and run-time platform, or IT deployment model. AOG – your trusted partner to help activate Medical AI outcomes.

 *Federal Food, Drug and Cosmetic Act:21 US CFR Chapter 9