AI / Machine Learning | September Round-Up 2025

October 14, 2025
Newsletter Update
Clinical Diagnostics

Highlights & Summary

September marked a month of steady integration between AI and the broader healthcare ecosystem. Drug discovery advances ranged from Lilly’s federated TuneLab platform to XtalPi’s first AI-designed cancer drug entering trials, while regulators expanded reimbursement and oversight for diagnostic AI. On the clinical side, Athenahealth and Epic deepened EHR automation, and new guidance from the AMA highlighted the growing need for governance as AI becomes routine in care delivery.

Featured DeciBio Insights  

1 | New Whitepaper: A Lack of Standardization: Navigating MRD Terminology and Specifications

2 | Upcoming Webinar: Engineering the Future of Cell Therapy: Access, Affordability, and Industrialization

3 | Upcoming Newsletter: Pharma Services

AI in Drug Discovery  

1 | Lilly Launches “TuneLab” AI/ML Platform for Biotech Access | New Product Launch

2 | Absci Partners with Oracle and AMD to Scale AI Drug Discovery Platform | Partnerships

3 | XtalPi and PharmaEngine’s AI-Discovered PRMT5 Inhibitor Advances to Clinical Trials | Partnership  

AI in Diagnostics  

1 | AMA Expands CPT 2026 Codes for AI Diagnostics and Remote Monitoring | Regulatory

2 | Aidoc Secures FDA Breakthrough Designation for Multi-Condition CT AI Platform | Regulatory

3 |  Cigna Adds Coverage for Cleerly’s AI Cardiovascular Imaging | Regulatory

 

AI in Healthcare  

1 | Athenahealth Introduces AI-Native EHR with Automated Clinical Insights | New Product

2 | AMA Advises Broad Stakeholder Involvement After Deploying Health AI | Regulatory

3 |  Onvida Health and Ambience Embed Ambient AI Tools into Epic Workflow | New Product

 

AI in Drug Discovery  

1 | Lilly Launches “TuneLab” AI/ML Platform for Biotech Access | New Product 

Eli Lilly has unveiled TuneLab, an AI/ML platform that grants biotechnology firms access to drug discovery models built on Lilly’s proprietary datasets, which the company says cost over $1 billion to generate. The system uses federated learning such that biotech partners can benefit from Lilly’s models without sharing their own data or exposing Lilly’s core data assets. In exchange for access, participants contribute training data to improve the models over time. The initial offering is integrated into Lilly’s Catalyze360 program, and future expansions are expected (e.g. predictive models for in vivo small molecules).

2 |  Absci Partners with Oracle and AMD to Scale AI Drug Discovery Platform | Partnerships

Absci announced a collaboration with Oracle and AMD to enhance its generative AI-based drug discovery platform. The partnership leverages Oracle Cloud Infrastructure and AMD’s Instinct GPUs to accelerate molecular dynamics simulations, antibody design, and large-scale model training. The move consolidates Absci’s infrastructure and reduces latency, allowing faster biologics design cycles. The companies aim to improve the performance and scalability of AI workflows to support more efficient drug development.

3 | XtalPi and PharmaEngine’s AI-Discovered PRMT5 Inhibitor Advances to Clinical Trials | Partnerships

XtalPi announced that its AI-driven collaboration with PharmaEngine has reached a key milestone as the novel PRMT5 inhibitor PEP08 received regulatory clearance for clinical trials in Taiwan and Australia. The compound was discovered using XtalPi’s AI drug design and quantum physics simulation platform, designed to optimize molecular potency and selectivity. PEP08 targets PRMT5, an epigenetic enzyme linked to cancer progression, and represents the first AI-designed compound from this partnership to reach human studies. Both companies plan to advance the candidate through early-phase trials to evaluate safety, pharmacokinetics, and antitumor activity.

AI in Diagnostics  

1 | AMA Expands CPT 2026 Codes for AI Diagnostics and Remote Monitoring | Regulatory

The American Medical Association’s 2026 CPT code update introduces new billing codes for remote patient monitoring and AI-based diagnostic tools. The revision adds five codes for shorter-term monitoring periods and new options for treatment management after 10 minutes of service. Notably, Cleerly’s AI coronary plaque analysis tool was upgraded from a temporary Category III to a permanent Category I code, improving reimbursement potential. Additional Category III codes were added for algorithmic tools analyzing perivascular fat, burn wound imaging, and cardiac dysfunction detection.

2 | Aidoc Secures FDA Breakthrough Designation for Multi-Condition CT AI Platform | Regulatory

Aidoc received FDA Breakthrough Device designation for its new AI platform that detects multiple acute conditions from a single CT scan. The system analyzes imaging data for issues such as stroke, pulmonary embolism, aortic dissection, and intracranial hemorrhage within one workflow. It is the first AI solution to span such a wide range of pathologies across organ systems. Aidoc aims to use this designation to expedite development and regulatory review toward clinical deployment.

3 |  Cigna Adds Coverage for Cleerly’s AI Cardiovascular Imaging | Regulatory

Cigna has approved insurance coverage for Cleerly’s AI-based coronary plaque analysis technology, effective October 1, 2025. The decision makes Cigna the latest major insurer, alongside UnitedHealthcare and EviCore, to reimburse Cleerly’s AI-QCT and AI-CPA tools for assessing coronary artery disease. Combined with existing Medicare coverage and upcoming CPT I codes, the inclusion extends access to more than 61 million Americans. The move reflects growing payer recognition of AI-driven imaging as a clinically validated tool for precision cardiovascular care.

 

AI in Healthcare  

1 | Athenahealth Introduces AI-Native EHR with Automated Clinical Insights | New Product

Athenahealth has launched a new AI-native version of its athenaOne electronic health record platform, aimed at simplifying clinician workflows in ambulatory care settings. The updated system includes features such as “clinically inferred diagnoses,” automated documentation assistance, and predictive insights within the EHR interface. The rollout, scheduled for fall 2025, integrates generative AI directly into core workflows to reduce administrative burden. The company positions the release as a foundation for future expansions in AI-supported clinical decision-making.

2 | AMA Advises Broad Stakeholder Involvement After Deploying Health AI | Regulatory

The American Medical Association recommends that health systems engage cross-functional teams like clinicians, engineers, ethics, IT before, during, and after implementation of AI in care delivery. The guidance emphasizes continuous monitoring of AI performance, bias, safety, and clinician feedback post-deployment. It also encourages institutions to establish governance mechanisms, transparency around AI decision-making, and clear accountability for outcomes. Finally, the AMA suggests adapting workflows, training staff, and aligning incentives to support responsible AI integration in medical practice.

3 |  Onvida Health and Ambience Embed Ambient AI Tools into Epic Workflow | New Product

Onvida Health is launching ambient AI functionality developed in partnership with Ambience Healthcare directly inside Epic’s electronic health record system. The integration includes AI tools for chart summarization, real-time documentation, coding assistance, and post-visit summaries. Clinicians across inpatient, outpatient, and emergency settings will pilot the system to reduce administrative burden and increase focus on patient care. The deployment is positioned to improve documentation accuracy, compliance, and workflow efficiency.

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