Who Owns AI Evaluation and Monitoring?

Imaging AI evaluation and monitoring just became even hotter topics, following a particularly revealing Twitter thread and a pair of interesting new papers.

Rads Don’t Work for AI – A Mayo Clinic Florida neuroradiologist took his case to Twitter after an FDA-approved AI tool missed 6 of 7 hemorrhages in a single shift and he was asked to make extra clicks to help improve the algorithm. No AI tool is perfect, but many folks commenting on this thread didn’t take kindly to the idea of being asked to do pro-bono work to improve an algorithm that they already paid for. 

AI Takes Work – A few radiologists with strong AI backgrounds clarified that this “extra work” is intended to inform the FDA about postmarket performance, while monitoring healthcare tools and providing feedback is indeed physicians’ job. They also argued that radiology practices should ensure that they have the bandwidth to monitor AI before deciding to adopt it.

The ACR DSI Gets It – Understanding that “AI algorithms may not work as expected when used beyond the institutions in which they were trained, and model performance may degrade over time” the ACR Data Science Institute (DSI) released a helpful paper detailing how radiologists can evaluate AI before and during clinical use. In an unplanned nod to the above Twitter thread, the DSA paper also noted that AI evaluation/monitoring is “ultimately up to the end users” although many “practices will not be able to do this on their own.” The good news is the ACR DSI is developing tools to help them.

DLIR Needs Evaluation Too – Because measuring whether DL-reconstructed scans “look good” or allow reduced dosage exams won’t avoid errors (e.g. false tumors or removed tumors), a Washington University in St. Louis-led team is developing a framework for evaluating DLIR tools before they are introduced into clinical practice. The new framework comes from some big-name intuitions (WUSTL, NIH, FDA, Cleveland Clinic, UBC), all of whom also appear to agree that AI evaluation is up to the users.

The Takeaway – At least among AI insiders it’s clear that AI users are responsible for algorithm evaluation and monitoring, even if bandwidth is limited and many evaluation/monitoring tools are still being developed. Meanwhile, many AI users (who are crucial for AI to become mainstream) want their FDA-approved algorithms to perform correctly and aren’t eager to do extra work to help improve them. That’s a pretty solid conflict, but it’s also a silver lining for AI vendors who get good at streamlining evaluations and develop low-labor ways to monitor performance.

Intelerad Acquires Ambra

Intelerad just got a whole lot bigger, acquiring Ambra Health to create one of the industry’s most comprehensive image management companies.

Acquisition Details – The acquisition values the combined companies at $1.7b, expands their reach to nearly 2k global customers (including all of the US’ top 10 hospitals), and brings their headcount to roughly 1k team members. Ambra CEO, Morris Panner, will become Intelerad’s president and will lead the company alongside CEO, Mike Lipps.

Intelerad + Ambra Portfolio – The acquisition combines Intelerad’s PACS portfolio with Ambra’s cloud VNA, image exchange, custom integration services, and research and pathology capabilities. 

Competitive Impact – At least in terms of portfolio breadth, this acquisition moves Intelerad into enterprise imaging’s top tier (radiology, cardiology, archive, sharing), helping it expand beyond its radiology practice legacy and deeper into hospitals. However, the star of this acquisition may prove to be combining Ambra’s cloud VNA with Intelerad’s cloud PACS, which as we’ve seen from Visage and Change’s recent cloud takeovers, can be a very effective combination.

Intelerad Growth – Intelerad has taken full advantage of its PE-backing, making a series of acquisitions since mid-2020 that allowed expansions into new specialties (cardiac & OB/GYN), regions (UK), and technologies (cloud). Ambra is clearly its biggest investment and most significant expansion yet.

The Diagnostic Gap

The Lancet Commission on Diagnostics just put a spotlight on the developing world’s alarmingly low access to diagnostics and how this situation can be addressed. 

The LMIC Gap – An unbelievable 47% of the global population has little to no access to diagnostics, with the vast majority of this diagnostic gap concentrated in low and middle-income countries (LMICs). This problem is greatest through LMICs’ primary care facilities (19% of people can access PCs w/ diagnostics), but also exists in hospitals (60%-70% of people can access hospitals w/ diagnostics).

The Impact – About 50% of people living with any of six key conditions in LMICs are undiagnosed (hypertension, type 2 diabetes, HIV, tuberculosis, syphilis & hepatitis B virus infection in pregnant women), making diagnostic access the world’s single greatest barrier to care. If undiagnosed rates for these six conditions were reduced to 10% in LMICs, it would avoid 1.1m premature deaths annually.

The Imaging Gap – There is a significant lack of imaging access in LMICs. Imaging access is lowest in primary care where only 5% of basic facilities and 12% of advanced facilities have ultrasound (never mind more advanced imaging). Meanwhile only 36% to 87% of hospitals in LMICs have working X-ray systems and just 2% to 29% of hospitals have a CT scanner (depending on the country).

The Problem – The authors largely blamed the developing world’s diagnostic gap on a lack of visibility and prioritization, although there’s a long list of other factors (corruption, costs, infrastructure, workforce).

The Solutions – The Lancet Commission believes that recent technology and informatics innovations could accelerate government efforts to improve diagnostic access. Until then, they recommend that LMICs develop national diagnostics strategies, ensure that standard diagnostic tests are available at various healthcare tiers (e.g. ultrasound at all primary care facilities), and prioritize improving diagnostic access through primary care facilities.

One Takeaway – Half the world doesn’t have access to diagnostics. This is mainly an economic problem, but imaging could play an outsized role in the solution considering that many of the latest imaging innovations are well suited for low-resource areas (e.g. handheld POCUS, AI diagnostics/guidance, portable MRI, teleradiology, etc.).

Aidoc & Riverain’s Platform Partnership

Aidoc and Riverain Technologies announced a new partnership that will make Riverain’s ClearRead CT and ClearRead Xray solutions available on the Aidoc platform, while advancing the companies’ respective platform strategies. 

The Chest AI Package – In addition to offering Riverain’s AI tools individually, Aidoc will provide them as part of an ‘integrated chest AI package’ that also includes Aidoc’s modules for PE, incidental PE, and rib fractures. 

Riverain’s Platform Push – Riverain has amassed a solid network of AI marketplace and OEM partners over the years, and it now appears to be expanding its channel to complementary AI vendors. Riverain’s new Aidoc alliance comes just a few weeks after a similar partnership with Volpara that combines ClearRead CT with the Volpara Lung platform.

Aidoc’s Platform Portfolio – After years of building out its homegrown AI portfolio (7 products) and customer base (600 health centers), Aidoc is evolving into an AI platform company. Over the last year, Aidoc has assembled a solid AI portfolio that combines its own triage products with solutions that it doesn’t offer (Imbio, Icometrix, Subtle Medical, Riverain), allowing its clients to expand their AI stack without overhauling their infrastructure with each new tool.

The Takeaway – We’re at an interesting time in the AI space with a small handful of diversified AI players (e.g. Aidoc, Qure.ai), a group of focused category leaders (e.g. Riverain w/ thoracic, ScreenPoint w/ mammography), and an AI customer base that would prefer not to support multiple AI infrastructures. Although marketplaces also solve this problem, it’s easy to see how complementary vendor partnerships like these could play a growing role in how AI is delivered going forward.

Siemens’ First Photon-Counting CT

The FDA announced the 510(k) clearance of Siemens Healthineers’ NAEOTOM Alpha photon-counting CT scanner, calling it “the first new major technological improvement for Computed Tomography (CT) imaging in nearly a decade.” Those are some big words from a federal agency not known for hyperbole, and it doesn’t appear they are exaggerating.

About Photon-Counting CTs – Photon-counting CTs (PCCTs) produce far higher quality images than traditional CTs, with lower radiation and contrast dosage. Unlike standard CTs that simultaneously measure the total energy from many X-rays (at the expense of image info, clarity, and contrast), photon-counting CT detectors directly convert each individual X-ray photon into digital electrical signals that are then “counted.”

The NAEOTOM Alpha – The NAEOTOM Alpha might be the first PCCT scanner, but the star of this announcement is its detector. The new photon-counting detector leverages a CdTe active detection layer to achieve PCCT’s targeted image/dosage/contrast advantages, and it could be the foundation of Siemens’ PCCT portfolio for years to come. 

The PCCT Race – The other major OEMs seem to be doing everything they can to earn a spot among the PCCT leaders. GE Healthcare and Canon both acquired PCCT detector makers within the last year and are planning their own PCCT launches, while Philips appears to have ramped up its PCCT R&D.

The Takeaway – PCCT has been viewed as the “future” of CT technology for quite a while, and that future just became a lot closer with last week’s announcement. We’re going to see similar PCCT launches from the other major OEMs, but Siemens Healthineers will enjoy its role as the only player with an FDA-approved PCCT scanner until then.

Intermountain’s Imaging Centers

Intermountain Healthcare expanded into outpatient imaging with the launch of its new imaging center subsidiary, Tellica Imaging. Plenty of hospital systems have outpatient imaging centers, but how and why Intermountain created Tellica brings some important takeaways.

About Tellica – Tellica Imaging plans to open a fleet of outpatient MRI and CT centers, starting with three Utah locations by late 2021, five locations in 2022, and more locations in “subsequent years.” The Tellica centers will prioritize patient convenience and value, targeting easy-to-access locations and adopting a novel flat-rate pricing model that’s well below typical in-hospital rates.

The Value-Based Angle – Given Intermountain’s role as one of the country’s flagship value-based care systems and its unique payor-provider structure, launching a series of imaging centers that are lower cost and more convenient makes a lot of sense. It’s also a step away from the hospital-based/owned procedure trend that’s helped hospitals from a reimbursement perspective, but brought a long list of unintended consequences (higher patient/payor costs, provider consolidation, imaging overuse, etc.).

The Payor Angle – Even though many patients use Intermountain’s in-house insurer (SelectHealth), Intermountain also works with a long list of commercial and government payors, nearly all of which have been incentivizing (or forcing) health systems to move more imaging procedures to outpatient centers. SelectHealth likely has the same preferences.

The Offsite Trend – In addition to the above payor pressures, there are some major trends underway that favor offsite imaging, including the rapid adoption of at-home/remote patient care, new COVID-related offsite policies, and the federal government’s efforts to make healthcare procedures more “shoppable.”

The Takeaway – Hospital-owned outpatient imaging centers aren’t all that unique, but Intermountain’s structure definitely is (payor-provider, value-based, non-profit) and so is its decision to launch these centers with such a patient-friendly value proposition. Even if most hospitals aren’t yet ready to offer flat-rate scans, the factors that drove Intermountain to create Tellica are likely forcing plenty of other systems to rethink their own approach to offsite imaging.

GE Acquires BK Medical

GE Healthcare’s ultrasound portfolio became a lot more diverse last week with its acquisition of surgical ultrasound company BK Medical. Here’s some details and perspectives:

The Acquisition – GE Healthcare will acquire BK Medical from Altaris Capital Partners for $1.45b, separating BK Medical from Analogic. That’s a pretty big investment considering that GE’s ultrasound unit brings in $3b a year.

GE’s Surgical Expansion – With BK Medical, GE’s ultrasound unit expands from diagnostics to intraoperative imaging and surgical navigation, which is reportedly a fast-growing and high-margin business for BK Medical. 

The BK Portfolio – BK Medical got its start in urology ultrasound, and more recently expanded to ultrasound systems used to guide minimally invasive and robotic surgeries and to visualize deep tissue during neuro and abdominal surgeries. That adds up to five unique ultrasound systems.

GE Impact – GE sees a lot of value in BK Medical. BK gives GE an ultrasound portfolio that the other OEMs can’t match (diagnostic, surgical, post-operative), “accelerates” GE’s precision health strategy, and will reportedly deliver “high-single-digit” ROI within five years.

GE Acquisition Trend – While GE Healthcare spent 2018 and 2019 selling major non-imaging businesses (value-based care to Veritas Capital, life sciences to Danaher), GE’s 2020 and 2021 acquisitions have focused on expanding its capabilities within imaging (Zionexa for radiopharmaceuticals, Prismatic Sensors for CT detectors, and now BK Medical for ultrasound). That says a lot about GE Healthcare’s imaging focus, and is quite different from Philips and Siemens, which have increasingly targeted M&A outside of imaging.

Silent Atherosclerosis

A new study in Circulation used coronary CTA scans and CAC scoring to reveal a surprisingly high prevalence of “silent” coronary artery atherosclerosis in the general population, suggesting that this could “lay the foundation” for future CT-based cardiac screening programs.

The Study – The researchers analyzed CCTA and CAC exams from 25k randomly recruited Swedish participants (50-64yrs, none w/ known coronary heart disease) finding that:

  • 42% had CCTA-detected atherosclerosis
  • 8.3% had noncalcified plaques
  • 5.2% had significant stenosis
  • 1.9% had serious coronary artery diseases
  • All participants with >400 CAC scores had atherosclerosis (yes, 100%), and 45.7% had significant stenosis
  • Some participants with 0 CAC scores had atherosclerosis (5.5%) and significant stenosis (0.4%)
  • So, CAC-based screening might still miss some at-risk patients

The Takeaway – 2021 brought a notable surge in academic and business efforts focused on CT-based cardiac screening, and this study’s revelation about “silent” atherosclerosis in the general population suggests that cardiac screening’s momentum will continue.

Volpara’s Lung Cancer Push

Breast imaging AI leader Volpara Health took a big step into the lung cancer AI segment last week, launching partnerships with Riverain Technologies and RevealDx. Here are some details.

Volpara & Riverain – Volpara and Riverain announced plans to integrate Riverain ClearRead CT (AI-based lung nodule detection) and the Volpara Lung platform (lung cancer screening reporting, tracking, and risk assessment), giving Volpara a market-leading detection partner and extending the clinical value of both tools.

Volpara & RevealDx – Within days, Volpara announced a $250k strategic investment in AI-based lung nodule diagnosis startup RevealDx, that will allow Volpara to sell RevealDx’s RevealAI-Lung tool (CE-marked, FDA pending) in the US and make Volpara its exclusive distributor in Australia / New Zealand. 

Not That Surprising – Volpara’s lung cancer screening expansion isn’t as surprising as some might think. Volpara first entered the lung cancer screening segment through its 2019 acquisition of MRS Systems, which likely targeted MRS’ breast cancer screening management software but also included its lung cancer screening platform (used w/ 8% of US LC screenings). Volpara also built its business around supporting population-scale cancer screening workflows and it has a long history of complementary partnerships within its breast imaging business.

The Takeaway – Lung cancer screening volumes are about to significantly increase in the US (and potentially globally), creating new bandwidth and workflow constraints, and driving demand for comprehensive solutions that support the entire screening and patient management pathway. With these alliances, Volpara, Riverain, and RevealDx are far better positioned to support that pathway.

Aidoc and Subtle Medical’s End-to-End Alliance

Aidoc and Subtle Medical launched an interesting new partnership that will make Subtle’s image acquisition / enhancement software available on the Aidoc AI platform.

End-to-End Partnership – The addition of SubtlePET and SubtleMR to the Aidoc AI platform will create what Aidoc called an “end-to-end” solution and “the first joint offering of AI for both image acquisition and triage.” Some folks might mistake that to mean that they will create new combined image acquisition+triage solutions, but they won’t be specifically linked (Aidoc doesn’t have MRI or PET tools yet anyway).

Aidoc, a Platform Company – Aidoc seems to be increasingly positioning itself as an AI platform company, which is an understandable strategy given users’ need for comprehensive / consistent AI workflows. Aidoc’s initial partnerships also allow the triage-focused vendor to offer a far more comprehensive value proposition (Subtle for acquisition, icometrix for stroke analysis/assessment).

Subtle Upsides – The alliance introduces Subtle Medical to Aidoc’s sizable list of clients (used at >500 medical centers, a high profile partnership w/ RP), and adds to Subtle’s current alliances with AI marketplace vendors (e.g. Blackford, Nuance, Incepto) and complementary solutions companies (e.g. Cortechs.ai).

The Takeaway – Although AI platform alliance stories don’t usually earn a spot at the top of The Imaging Wire, this alliance is pretty notable given what it suggests about Aidoc’s AI platform strategy and about the growing trend towards complementary AI alliances. It’s also a nice way for Subtle Medical to expand its reach.

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