FDA Data Show AI Approval Boom

In the previous issue of The Imaging Wire, we discovered how venture capital investment in AI developers is fueling rapid growth in new AI applications for radiologists (despite a slowdown this year). 

This trend was underscored late last week with new data from the FDA showing strong growth in the number of regulatory authorizations of AI and machine learning-enabled devices in calendar 2023 compared to the year before. The findings show:

  • A resurgence of AI/ML authorizations this year, with over 30% growth compared to 14% in 2022 and 15% in 2021 – The last time authorizations grew this fast was in 2020 (+39%)
  • The FDA authorized 171 AI/ML-enabled devices in the past year. Of the total, 155 had final decision dates between August 1, 2022 to July 30, 2023, while 16 were reclassifications from prior periods 
  • Devices intended for radiology made up 79% of the total (122/155), an impressive number but down slightly compared to 87% in 2022 
  • Other medical specialities include cardiology (9%), neurology (5%), and gastroenterology/urology (4%)

One interesting wrinkle in the report was the fact that despite all the buzz around large language models for generative AI, the FDA has yet to authorize a device that uses generative AI or that is powered by LLMs. 

The Takeaway

The FDA’s new report confirms that radiology AI shows no sign of slowing down, despite a drop in AI investment this year. 

The data also offer perspective on a JACR report last week predicting that by 2035 radiology could be seeing 350 new AI/ML product approvals for the year. Product approvals would only have to grow at about a 10% annual rate to hit that number – a figure that seems perfectly achievable given the new FDA report.

Making Screening Better

While population-based cancer screening has demonstrated its value, there’s no question that screening could use improvement. Two new studies this week show how to improve on one of screening’s biggest challenges: getting patients to attend their follow-up exams.

In the first study in JACR, researchers from the University of Rochester wanted to see if notifying people about actionable findings shortly after screening exams had an impact on follow-up rates. Patients were notified within one to three weeks after the radiology report was completed. 

They also examined different methods for patient communication, including snail-mail letters, notifications from Epic’s MyChart electronic patient portal, and phone calls. In approximately 2.5k patients within one month of due date, they found that follow-up adherence rates varied for each outreach method as follows:

  • Phone calls – 60%
  • Letters – 57%
  • Controls – 53%
  • MyChart notifications – 36%

(The researchers noted that the COVID-19 pandemic may have disproportionately affected those in the MyChart group.) 

Fortunately, the university uses natural language processing-based software called Backstop to make sure no follow-up recommendations fall through the cracks. 

  • Backstop includes Nuance’s mPower technology to identify actionable findings from unstructured radiology reports; it triggers notifications to both primary care providers and patients about the need to complete follow-up.

Once the full round of Backstop notifications had taken place, compliance rates rose and there was no statistically significant difference between how patients got the early notification: letter (89%), phone (91%), MyChart (90%), and control (88%). 

In the second study, researchers in JAMA described how they used automated algorithms to analyze EHR data from 12k patients to identify those eligible for follow-up for cancer screening exams.

  • They then tested three levels of intervention to get people to their exams, ranging from EHR reminders to outreach to patient navigation to all three. 

Patients who got EHR reminders, outreach, and navigation or EHR reminders and outreach had the highest follow-up completion rates at 120 days compared to usual care (31% for both vs. 23%). Rates were similar to usual care for those who only got EHR reminders (23%).

The Takeaway

This week’s studies indicate that while health technology is great, it’s how you use it that matters. While IT tools can identify the people who need follow-up, it’s up to healthcare personnel to make sure patients get the care they need.

HIMSS 2022 Reflections

Two years after HIMSS became COVID’s first trade show casualty, healthcare’s leading IT conference returned to Orlando with a very post-COVID vibe and a surge in imaging activity. 

Hope you had a blast if you made it to HIMSS, and here’s some highlights in case you didn’t:

The HIMSS Crowd – Unlike the Delta-impacted HIMSS 2021 conference, this year’s event boasted a full exhibitor list and reportedly solid health IT leadership attendance. However, exhibitor staff often appeared to outnumber potential customers on the show floor, prompting conversations about whether HIMSS is evolving into a B2B event and causing some vendors to question where imaging sits on IT executives’ list of priorities. 

The Mixed Cloud – PACS and enterprise imaging vendors continued to ramp up their cloud capabilities and cloud leadership messaging, with nearly everyone agreeing that the future will bring far more cloud adoption. It was also clear that many radiology practices and hospital systems (and even some PACS vendors) are still taking it slow on their path towards the cloud. 

AI in the Aisles – Only a handful of imaging AI companies had booths this year, but it wasn’t hard to find folks from AI startups walking the show floor or in meeting rooms. That’s actually consistent with previous HIMSS conferences, and it makes a lot of sense given AI startups’ limited budgets and the low count of radiology leaders at the show.

AI in the Enterprise – Although we didn’t hear much about all those PACS-based AI platforms / marketplaces that were announced several years ago, AI was positioned at the center of quite a few PACS vendors’ future diagnostic workflow strategies. These strategies still largely focused on integrating third-party AI tools, but several major enterprise imaging players (e.g. Canon, Fujifilm, Siemens) also forecasted a greater future role for their own homegrown AI tools.

The Productivity Press – With imaging growing in volume / complexity at a much faster rate than imaging teams’ own headcounts / capabilities, just about every product message focused on improving productivity and efficiency. HIMSS 2022 saw imaging vendors address this in a wide variety of ways, including remote modality operation, ultrasound AI automation, automated scanner setup, and hanging protocol standardizing (to name a few).

Expanding Ologies – HIMSS also revealed more multi-ology progress as enterprise imaging players better connected their solutions, added new ology-expanding partnerships, and integrated their acquired companies. That said, it seems like the majority of “enterprise” imaging engagements are still limited to radiology, or at least starting there.

Looking Beyond Imaging – A walk around the show floor suggests that healthcare tech is evolving at a much faster pace outside of imaging, with major adoption and technology advances in telemedicine, patient monitoring, at-home and hybrid care, and patient engagement. Although most of these solutions have little to do with radiology right now, these efforts could change how and where many patients get their care, which would have an impact on nearly all specialties. By the way, we have an excellent newsletter about this space for those looking to keep up with these trends. 

The Takeaway

After one year of digital conferences and another year of minimally-attended hybrid events, the bar has been set pretty low for 2022 trade shows. That said, HIMSS had everything that you would expect from a successful post-COVID trade show (plenty of vendors, exciting tech, strong attendance, good vibes), which is a good sign for future events as long as the pandemic cooperates.

Although HIMSS 2022 didn’t necessarily reveal any major focus changes for imaging IT, it did showcase some solid progress advancing the major imaging trends that we’ve seen over the last few years (cloud, AI, productivity, enterprise-expansion), and we’re excited to see what else this year has in store.

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