PACS is MIMPS | AI Trough | Long Haul Imaging

“No way am I going to be known as the MIMPSMan.”

A LinkedIn comment from the “PACSMan” Michael J. Cannavo after the FDA changed PACS’ name to MIMPS.

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The Imaging Wire

Another Week in the Disillusionment Trough

Imaging AI is having another tough week after the release of a pair of studies detailing AI’s sizable adoption and evidence gaps and two big warnings that increased regulatory scrutiny is on the way. Here are some details:

  • The AI Evidence Gap – A study published in European Radiology found that only 36 out of 100 CE Marked imaging AI products were backed by peer-reviewed studies, while just 18 products showed evidence of their clinical impact (diagnostic thinking, patient outcome, or costs).
  • AI Adoption Curve – An ACR Data Science Institute survey of 1,427 U.S. radiologists found that 33.5% of rads are currently using imaging AI, but because their practices only use an average of 1.2 AI products, imaging AI’s actual U.S. market penetration is really just ~2%. That might make AI a blue ocean product segment, but only 20% of the remaining practices plan to adopt AI within the next 5 years.
  • FTC’s AI Bias Warning – The U.S. FTC warned that businesses selling or using AI algorithms that produce biased results (age, race, religion, etc.) could be violating federal laws — and that definitely includes healthcare algorithms. The FTC post was largely intended to help AI makers/users stay on the right side of these laws, but also warned that they should hold themselves accountable “or be ready for the FTC to do it for (them).”
  • EU’s Strict AI Stance – Europe proposed a strict set of AI rules intended to “make sure A.I. can be trusted,” setting the stage for significantly more stringent AI oversight and far more severe penalties. The proposed rules go well beyond healthcare (e.g. self-driving cars, law enforcement, banking), although healthcare AI products may fall under the EU’s more stringent “high-risk” AI rules that would require proof of safety and a higher level of explainability.

Like AI’s previous week in the “Trough of Disillusionment,” this week’s events shouldn’t come as a major surprise to folks paying attention to this space. Most imaging AI insiders would agree that there’s a lot of room to improve clinical evidence, many might see the increased regulatory oversight as a necessary (especially given the lack of clinical evidence), and most should view AI’s 2% penetration as good news from a market opportunity standpoint. Still, weeks like this are a helpful reminder of how much further imaging AI has to evolve.

The Wire

  • PACS is Now MIMPS: The FDA just renamed PACS as MIMPS (Medical image management and processing system) as part of a Cures Act-driven update that also excluded image storage / transfer / display products from requiring FDA approval and reclassified VNAs and viewers as non-medical devices. MIMPS will remain an FDA-regulated medical device used for image interpretation (including segmentation, manipulation, and quantitative functions). Although this name change might create branding challenges and personal identity crises for some folks on the “PACS” side of imaging, the associated reclassifications will likely alleviate regulatory headaches for these same companies.
  • COVID Imaging’s Long Haul: Radiology departments should prepare to support COVID long-haulers’ ongoing imaging needs, even after the pandemic subsides. That’s from a study presented at this week’s ARRS 2021 annual meeting, suggesting that patients with severe or extended COVID bouts are likely to require ongoing imaging exams to monitor and manage complications (including lung, cardiac, and brain), and warning that the long-term effects we’ve seen so far in COVID patients “may only be the tip of the iceberg.”
  • SimonMed Gets PE-Backed: Major U.S. outpatient imaging company, SimonMed (~200 rads, 147 facilities, 11 states), just entered an estimated $600m “strategic partnership” with PE firm, American Securities. Although some in the imaging media called this another sign of practice consolidation, it’s really another sign of PE’s growing influence over radiology, and a likely precursor to more aggressive moves from SimonMed (that could definitely lead to more consolidation).
  • Marijuana’s Lung Impact: A study from this week’s ARRS 2021 meeting provided rare insights into marijuana’s effects on the lungs, finding that smoking marijuana indeed leads to higher rates of emphysema and airway diseases. Two blinded radiologists reviewed chest CTs from 56 marijuana smokers, 57 non-smokers/non-marijuana users, and 33 tobacco-only smokers, finding that marijuana smokers had far higher rates of emphysema (75% vs. 5% non-smokers), bronchial thickening (64% vs 11% both control groups), bronchiectasis (23% vs 4% both control group), and mucoid impaction (87% vs 2% both control group).
  • Canon’s One-Beat CV CT: Canon Medical announced the FDA clearance of its Deep Learning Spectral CT software’s new one-beat cardiovascular imaging application. Available with the company’s Aquilion ONE / PRISM Edition CT system, the one-beat feature allows healthcare providers to acquire whole-heart spectral images in one heartbeat (0.275 seconds).
  • What Imaging Patients Are Asking: Many patients have lingering questions about their radiology reports. That’s from a new University of Wisconsin-led study that reviewed 659 imaging-related questions posted by patients on online Q&A platforms (e.g. Reddit, Quora, Wiki Answers), finding that 234 (35.5%) patient questions were about their radiology reports. Of the 234 radiology report questions, the patients were primarily interested in better understanding their reports (62, 26.5%), what they’re seeing in their medical images (53, 22.6%), and how the reports are structured (46, 19.7%).
  • DeepHealth’s FDA: RadNet’s DeepHealth subsidiary just gained FDA approval for its Saige-Q mammography triage and worklist prioritization software, representing the first FDA-approved solution from DeepHealth/RadNet and the first from anyone to triage both 2D and 3D mammograms. This certainly represents a milestone for RadNet, which has actively sought out AI acquisitions (DeepHealth, Nulogix) and partnerships (Hologic, WhiteRabbit.ai) over the last two years, and now plans to submit a “more advanced” diagnostic mammography algorithm for FDA review.
  • Imaging Optimism: The AHRA’s latest Medical Imaging Confidence Index (MICI) revealed that U.S. imaging managers/directors (n = 160) feel confident about how they’ll perform in H1 2021. The new report revealed a “high” 115 overall confidence score (vs. 109 in Q4 2020), helped by their confidence in scan/IR volume growth (128 vs. 124), cost stability (127 vs. 129), and imaging’s role as a profit center (134 vs. 129). The imaging leaders had lower (but still improving) confidence about their access to capital (100 vs. 86) and whether they’ll receive adequate reimbursements (94 vs. 90).
  • Carestream & Ziehm’s C-arm Alliance: Carestream will distribute Ziehm Imaging’s Ziehm Vision RFD mobile C-arm system, adding Carestream to the relatively exclusive list of OEMs offering mobile C-arms in the U.S. (GE, Siemens, Philips, Ziehm) and expanding Ziehm’s U.S. presence.
  • Radiologists in the Loop AI: A new paper in European Radiology detailed the wide range of roles radiologists can play in AI development and suggested that radiologists can/should increase their levels of engagement within these companies. The authors studied eight global imaging AI companies, identifying 9 key radiologist roles in AI development (problem finder, problem shaper, problem dominator, data researcher, data labeler, data QC, algorithm shaper, algorithm tester, AI researcher) and finding that radiologist engagement / interaction levels vary widely between companies.
  • Fujifilm’s Healthcare VISION: Fujfilm’s new “VISION2023” 3-year strategic plan places a major emphasis on healthcare, revealing a goal to devote much of Fujfilm’s $11b growth fund to making its healthcare business the company’s largest segment. Healthcare has been among Fujifilm’s top priorities for quite a while, leading to a number of key acquisitions including Hitachi’s imaging business, and its next healthcare growth phase will focus on creating a complete and AI-enabled imaging portfolio and continuing growth in its Bio CDMO and Life Sciences businesses.

The Resource Wire

– This is sponsored content.

  • With radiation dose management now largely considered best practice, this Bayer white paper details the top five benefits of adopting contrast dose management.
  • It’s clear that structured reporting is a must for CVIS platforms, but they aren’t all created equal. This Hitachi article reveals what physicians and sonographers view as the “non-negotiable” CVIS structured reporting features.
  • With the gap between AI interest and AI adoption becoming increasingly clear, this GE Healthcare post details how AI startups can bridge that gap.
  • This Riverain Technologies case study details how Duke University Medical Center integrated ClearRead CT into its chest CT workflows, reducing read times by 26% and improving nodule detection by 29%.
  • Did you know Arterys developed the first ever FDA-cleared algorithm leveraging cloud computing and artificial intelligence? Check out this comprehensive database of strictly AI/ML-based medical technologies that have been approved by the FDA.
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  • Did you know roughly half of all follow-up recommendations are never completed? Check out this upcoming Nuance panel presentation, where providers will share how their organizations are proactively addressing the issue of failed follow-up to ensure that patients don’t fall through the cracks.

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