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Will FDA Cuts Slow AI Adoption? | AI Trust Wavers
February 20, 2025
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Together with
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“Unfortunately, the Agency finds that you are not fit for continued employment because your ability, knowledge and skills do not fit the Agency’s current needs, and your performance has not been adequate to justify further employment at the Agency.”
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Text from a termination email sent to FDA employees on February 15.
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Our next webinar, Insights and Tips on Helping the Independent Imaging Practice Thrive in 2025, starts later today at 12 pm ET/9 am PT. There’s still time to reserve your seat and learn how radiology IT tools are helping independent practices operate more efficiently.
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The Trump Administration’s campaign to cut the federal workforce arrived at the FDA last weekend – in particular its division regulating AI in healthcare. Multiple staff cuts were reported at the Center for Devices and Radiological Health, which had been in the midst of a major overhaul of AI regulation.
A February 15 article in STAT News first reported the layoffs, which as with other recent staff reductions concentrated on FDA employees with probationary status and was part of a larger initiative that has also affected the CDC and NIH.
The rapid growth of medical AI has had a major impact on the center, which as of its last report had given regulatory authorization to over 1k AI-enabled devices (76% of which are for radiology).
- To deal with the deluge, CDRH reportedly had been hiring many new staffers who were still on probationary status, making them targets for layoffs (permanent federal employees have civil service protections that make them harder to fire).
FDA also has been retooling its regulatory approach to AI with new initiatives that reflect the fact that AI products continue learning (and changing) after they’ve been approved, and thus require more aggressive post-market surveillance than other medical devices…
So what impact – if any – will the layoffs have on the rapidly growing medical AI segment?
- The FDA may simply scale back its new AI initiatives and regulate the field under more traditional avenues that have served the medical device industry well for decades.
In another scenario, the FDA’s frenzied pace of AI approvals and initiatives could slow as the agency struggles to handle a growing number of product submissions with less staff.
The Takeaway
The FDA layoffs couldn’t have come at a worse time for medical AI, which is on the cusp of wider clinical acceptance but still suffers from shaky confidence and poor understanding on the part of both providers and patients (see story below). The question is whether providers, organized radiology, or developers themselves will be able to step into the gap being left.
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Meet Gleamer at ECR 2025 in Vienna
Visit Gleamer at ECR 2025 in Vienna and learn about the scientific evidence behind the performance and excellence of their AI solutions for musculoskeletal and chest imaging. Book a meeting today or visit them at booth #AI-17.
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Answers in Sight at HIMSS 2025
Join Intelerad at HIMSS 2025 to explore how they are redefining healthcare imaging with innovative solutions designed to provide a clear path to answers. Book a meeting today or drop by at booth #1048.
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What Does Improved MRI Efficiency Mean?
There’s a growing need for practical, cost-effective solutions to improve efficiency in MRI and other modalities. Read this article from Karen Holzberger of SpinTech MRI and James Backstrom, MD, to learn how the company’s STAGE software can help.
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- Patients Don’t Trust Medical AI: Patients have low levels of trust that healthcare providers will use medical AI responsibly and protect them from AI-related harms. In a survey of 2k patients published in JAMA Network Open, only 34% said they thought their health system would use AI responsibly, and only 42% thought their provider would make sure that AI would not harm them. Researchers said the findings show a need for better communication about AI to patients and to invest in “organizational trustworthiness.”
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- Lung CT Scans Find Heart Disease: Patients getting CT scans for lung cancer also had detectable signs of cardiovascular disease. In 276 lung cancer patients getting staging CT scans, researchers found that 78% had detectable atherosclerosis, as well as elevated systolic and diastolic blood pressure. Patients in the study group had high risk factors for heart disease, including obesity (27%) and smoking status (89%). The study suggests that cardiovascular tests like coronary artery calcium scoring could be added to CT lung screening exams.
- Enlitic Lands GE HealthCare: Enlitic landed a big fish this week: GE HealthCare, which will offer the company’s solutions for data standardization and migration as part of GE’s software as a service and cloud transformation offerings. GE customers will get access to Enlitic subsidiary Laitek’s data migration technologies to speed their conversion to GE’s newest enterprise imaging and PACS platforms, as well as Enlitic’s Ensight Suite solution for embedding AI automation and data intelligence into migration tools.
- Payment Status Affects Fibroid Treatment: A new study in JACR found a connection between insurance status and whether women got minimally invasive uterine artery embolization to treat fibroids. In a review of 581k fibroid treatments, women on Medicaid were 38% more likely to get UAE versus hysterectomy or myomectomy than women with commercial insurance, and women from states with higher hysterectomy Medicaid reimbursement were 5% less likely to get UAE. Researchers theorized that clinicians steered women to hysterectomy if payments for that procedure were higher.
- Disparities in Breast Cancer Services: Meanwhile, researchers in a study in Radiology found racial and ethnic disparities in services provided to breast cancer patients. In a review of screening mammograms for 1.1M women at 136 U.S. facilities, race or ethnic status was not associated with overall availability of on-site diagnostic service, but minority patients were less likely to receive same-day service after abnormal screening mammograms compared to White patients, including Black women (RR=0.56), Hispanic women (RR=0.61), and Asian patients (RR=0.74).
- Gleamer Launches Breast AI: French AI developer Gleamer has begun European commercial sales of BreastView, a new 2D mammography AI algorithm that the company previewed in late 2024. The algorithm was trained on the company’s foundation model technology, and the launch represents Gleamer’s expansion from its core focus on fracture detection into new clinical areas. BreastView has the CE Mark but has not yet received FDA clearance.
- AI Automatically Segments MR Images: Researchers from Switzerland developed an AI model that automatically segments MR images and works across different scanners and image acquisition sequences. Called TotalSegmentor MRI, researchers trained the algorithm on 616 MRI and 527 CT exams and had it perform segmentations on 80 different anatomic structures. They found it outperformed two publicly available segmentation models based on Dice scores (0.86 vs. 0.84 and 0.56) and matched the performance of a related model for CT, TotalSegmentor CT.
- Prenuvo Raises $120M to Fuel Expansion: Whole-body MRI screening provider Prenuvo announced that it “quietly” raised $120M during 2024 as part of a Series B funding round. Prenuvo also announced it surpassed 110k members and got FDA clearance for its Prenuvo Body Composition report, which includes body composition analysis, a new scan on brain function and cognitive health, and functional and conventional blood bio-marker assessment. The three tests will be offered in a bundled package called Prenuvo Enhanced at locations in Silicon Valley, Los Angeles, and New York City.
- HeartLung Signs SimonMed: HeartLung Technologies signed a partnership to provide its AI-enabled AutoBMD bone mineral density analysis solution to SimonMed Imaging for opportunistic detection of osteoporosis on CT scans. The algorithm uses data from existing CT scans to generate bone density reports with Z scores and T scores similar to those provided by DEXA scanners. Previous research has shown good agreement between AutoBMD and manual measurements of bone density.
- SubtleHD Gets FDA Clearance: Subtle Medical received FDA clearance for its SubtleHD AI algorithm for accelerating MRI scans through image denoising and sharpening. With the clearance, Subtle is launching Subtle-ELITE, a suite of AI tools that includes SubtleHD, SubtleSYNTH, and SubtleALIGN, which together can improve image quality while reducing MRI scanning times 80% for certain sequences.
- Aidoc Touts New Clearance: Aidoc received FDA clearance for an AI fracture detection algorithm, the company’s first offering built on its foundation model technology for training algorithms. The Rib Fractures triage solution detects fractures on trauma CT scans and was built on Aidoc’s CARE1 foundation model; the company announced in December 2023 that it was investing $30M to develop a clinical AI foundation model. Aidoc plans to release CARE2, the next version of the foundation model, in coming months.
- PE Firm Buys IMRIS: Intraoperative MRI developer IMRIS was acquired by Grovecourt Capital Partners, a private equity firm based in Florida. IMRIS markets an MRI scanner attached to a ceiling-mounted rail system that moves between diagnostic and operating rooms to provide guidance during neurosurgery procedures. Grovecourt said they hope to expand IMRIS’ focus into new applications like laser ablation and high-intensity focused ultrasound treatments.
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Challenges and Opportunities in Radiology
In this episode of Medality’s The Radiology Report podcast, Medality Co-Founder and CEO Daniel Arnold interviews Glenn Kaplan, MD, about the challenges and opportunities in radiology, including workforce shortages and capacity issues, and possible solutions.
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Ignite Your AI Strategy at ECR 2025
Learn how to ignite your AI strategy at ECR 2025 with Calantic by Bayer’s AI platform for radiology. Book a demo today at booth #AI-03 and be sure to attend one of the company’s presentations in Vienna.
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MRI That’s Lighter, Faster, and Sharper
Rise above and experience MRI excellence with Philips BlueSeal, the industry’s lightest, vent pipe-free, high-performance, helium-free 1.5T scanner. Watch this video to see how it can benefit your practice.
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- Medical Imaging Data for Improved Research: The need for high-quality medical imaging data is crucial to drive advancements in diagnostics and treatment. Schedule a demo today to learn how Enlitic’s ENDEX for data standardization and ENCOG for data anonymization enable researchers to access superior data while optimizing resources.
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- Enhance Efficiency, Enhance Care: Find out how Optum’s cloud platform integrates effortlessly with your existing systems, boosting both care and efficiency. Visit now!
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