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STAT+: FDA announces sweeping changes to oversight of wearables, AI-enabled devices
LAS VEGAS — The Food and Drug Administration announced Tuesday that it will ease regulation of digital health products, following through on the Trump administration’s promises to deregulate artificial intelligence and promote its widespread use.
FDA Commissioner Marty Makary indicated that one of the agency’s priorities is fostering an environment that’s good for investors, and that FDA regulation needs to move “at Silicon Valley speed.” He announced the changes during an address to conference attendees at the Consumer Electronics Show.
The agency will soften its approach to the regulation of clinical decision support software, which include AI-enabled products that help doctors navigate diagnoses and treatment options. The agency previously considered products that delivered a single recommendation as FDA-regulated medical devices. Now, those products can enter the market without FDA review as long as they fulfill the agency’s other criteria for escaping regulation.
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PRIME: an interpretable artificial intelligence model based on liquid biopsy improves prediction of progression risk in non-small cell lung cancer
Mil Med Res. 2026 Jan 6;12(1):94. doi: 10.1186/s40779-025-00679-z.
ABSTRACT
BACKGROUND: Despite the predictive impact of circulating tumor DNA (ctDNA) minimal residual disease (MRD), accurate prediction of failure risk after curative-intent treatments for early-stage or localized non-small cell lung cancer (NSCLC) patients to guide personalized therapy remains challenging. This study aimed to develop and validate an interpretable artificial intelligence-assisted model using global data resources.
METHODS: Liquid biopsy data, blood-based genomic alterations, clinicopathological features, and survival outcomes of stage I-III NSCLC patients who underwent surgery or definitive chemoradiotherapy were collected from 6 cohorts. PRIME (Progression Risk prediction by Interpretable Machine learning on ctDNA-MRD, Mutations, and clinical-therapeutic features) was trained by 6 machine learning algorithms across 4 cohorts and validated in 2 independent cohorts. Model performance was evaluated by the area under the curve (AUC) and interpreted by SHapley Additive exPlanations (SHAP). Whole-exome sequencing (WES) or whole-genome sequencing (WGS) of tumor tissue from 430 stage II-III NSCLC patients and RNA-sequencing (RNA-seq) data from 1149 subjects, sourced from The Cancer Genome Atlas, were used to validate the prognostic effect of mutations identified in peripheral blood and investigate the underlying mechanisms.
RESULTS: A global dataset encompassing 781 blood samples from 493 patients was analyzed. Clinical stage, pre-treatment ctDNA, post-treatment MRD, blood-based Kelch-like ECH-associated protein 1 (KEAP1), serine/threonine kinase 11 (STK11), and cyclin-dependent kinase inhibitor 2A (CDKN2A) mutations, and treatment modality were significantly associated with the risk of disease progression and were thereby included in the model training. WES/WGS and RNA-seq confirmed the poor prognostic effect of KEAP1, STK11, and CDKN2A mutations, which were characterized by the suppressive tumor microenvironment and attenuated humoral immunity. The neural network (NN) model exhibited optimal prediction of treatment failure risk in the training (AUC = 0.85, 95% CI 0.81-0.89) and validation sets (AUC = 0.82, 95% CI 0.74-0.89). SHAP analysis indicated that MRD (+0.306), treatment modality (+0.128), and pre-treatment ctDNA (+0.043) ranked in the top 3 contributions. NN-PRIME outperformed single liquid biopsy biomarkers and clinical-therapeutic signatures, and demonstrated consistent robustness across different clinical scenarios. High-risk patients identified by NN-PRIME had poorer prognoses but derived significant benefits from adjuvant therapy after surgery.
CONCLUSIONS: As an interpretable model integrating readily-accessible and crucial clinical-genomic predictors, PRIME achieves enhanced performance, allowing for early outcome prediction, refined risk stratification, and personalized clinical decision-making.
PMID:41491583 | PMC:PMC12771999 | DOI:10.1186/s40779-025-00679-z
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A machine learning-derived polygenic risk score reveals that healthy lifestyle counteracts obesity-related mortality
npj Digital Medicine, Published online: 06 January 2026; doi:10.1038/s41746-025-02314-6
A machine learning-derived polygenic risk score reveals that healthy lifestyle counteracts obesity-related mortalityMoving beyond monogenic disorders in clinical healthcare
Nature Biotechnology, Published online: 05 January 2026; doi:10.1038/s41587-025-02931-2
Our understanding of the genetic mechanisms underlying rare diseases has rapidly advanced over the past decade, largely because of technological innovations. Yet clinical practice still has a strong monogenic focus, leaving many individuals undiagnosed. This Comment outlines how technological advances such as long-read sequencing should be adopted to increase multivariant testing in the clinic.The ethics of multi-cancer screening
Nature Medicine, Published online: 05 January 2026; doi:10.1038/s41591-025-04111-w
Multi-cancer detection tests offer a new paradigm in cancer screening — the use of a single test to simultaneously screen for many cancers — but they raise important ethical questions for their development, evaluation and possible implementation.