10:35

Feb 20, 2026

02/20/2026 - FDA Single Trial Standard, GE MRI Deep Learning Clearances, Digital Health Center Leadership

This episode examines the FDA’s formalization of single-trial evidentiary standards for new drug applications, supported by confirmatory evidence including mechanistic data, real-world evidence, and computational modeling. The briefing reviews three five ten k clearances for GE Healthcare MRI systems integrating deep learning reconstruction algorithms designed to reduce scan times and improve image quality. The episode concludes with the appointment of Rick Abramson as director of the Digital Health Center of Excellence, following January policy adjustments that altered regulatory pathways for clinical decision-support AI and expanded wellness product exemptions from premarket review.

8:56

Feb 19, 2026

02/19/26 - Stealth AXiS Surgical Navigation, Utah Autonomous Prescription AI, Hikma v Amarin Induced Infringement

This episode examines the FDA clearance of Medtronic’s Stealth AXiS system for AI driven robotic spine surgery, Utah’s regulatory mitigation agreement for autonomous medication renewals covering one hundred ninety chronic conditions, and the Supreme Court’s certiorari grant in Hikma versus Amarin on induced infringement doctrine for skinny label generics. Additional coverage includes Federal Circuit rulings narrowing Orange Book patent listing criteria for combination drug delivery devices, and the Commissioner’s National Priority Voucher program structure and approval timelines. The briefing contextualizes these developments within evolving frameworks for algorithmic governance, patent liability, and expedited regulatory pathways.

10:15

Feb 18, 2026

02/18/26 - Copan PhenoMATRIX Clearance, Medtronic Stealth AXiS Integration, AI Drug Candidates at 90% Phase I Success

This episode covers the FDA’s February seventeenth clearance of Copan’s PhenoMATRIX software for AI-assisted bacterial culture plate sorting across multiple media types, Medtronic’s Stealth AXiS platform integrating AI-driven planning and navigation for spine procedures, and the ninety percent Phase I success rate of drug candidates generated through generative AI platforms. It also examines a UC San Diego large language model workflow achieving ninety-nine percent accuracy in colorectal cancer risk prediction for ulcerative colitis patients, and the FDA’s recent pattern of issuing complete response letters to applications meeting predefined endpoints, affecting sponsor valuation models and development strategy. Listeners gain insight into regulatory pathways for diagnostic and surgical AI, computational drug development economics, and evolving benefit-risk frameworks shaping late-stage clinical programs.

10:24

Feb 17, 2026

02/17/26 - HeartBeam ECG Synthesis Clearance, LEX VELO CLIA Waiver, FDA Digital Health Boundary Updates, Disc Medicine CRL

This episode examines HeartBeam’s FDA clearance for twelve lead ECG synthesis software following appeal, LEX Diagnostics’ CLIA waived respiratory PCR platform, updated FDA guidance clarifying regulatory boundaries for AI enabled clinical decision support and wellness devices, CStone Pharmaceuticals’ IND clearance for CS2009 trispecific antibody trials across fifteen cohorts, Medtronic’s Stealth AXiS spine robotics platform approval with LiveAlign segmental tracking, and the Complete Response Letter issued to Disc Medicine for bitopertin in erythropoietic protoporphyria based on biomarker to clinical endpoint correlation gaps. The briefing covers regulatory pathway divergence across point of care diagnostics, digital health classification frameworks, oncology trial design, and surgical infrastructure consolidation.

11:20

Feb 14, 2026

02/14/26 - Neurophet AQUA AD Plus Clearance, Medtronic LiveAlign Tracking, FDA Real World Evidence Guidance

This episode covers Neurophet’s third FDA clearance for multimodal Alzheimer’s neuroimaging with automated lesion detection, Medtronic’s Stealth AXiS spine platform introducing real time segmental motion tracking, and GE HealthCare’s AI driven cardiac ultrasound system reporting eighty percent keystroke reduction. Additional coverage includes real world evidence from stroke triage studies across NHS and U.S. emergency settings, FDA’s rescission of the Laboratory Developed Test rule, updated real world evidence guidance emphasizing relevance and reliability assessment, and revised cybersecurity and AI lifecycle management frameworks for medical device software.

8:16

Feb 10, 2026

02/10/26 - Dual FDA Clearances for Lung Nodule AI, Medicare Reimbursement Pathways, UV-C Cardiac Probe Disinfection

This episode examines two FDA-cleared AI systems for pulmonary nodule detection and characterization—eyonis LCS from Median Technologies and RevealAI-Lung from RevealDx—both cleared within one week and both reimbursable under Medicare Category III CPT codes. The briefing covers clinical performance benchmarks including sensitivity, specificity, and negative predictive value, the validation frameworks used in pivotal trials and multi-cohort studies, and the reimbursement infrastructure enabling immediate deployment. The episode concludes with UV Smart Technologies’ clearance of the D sixty UV-C disinfection system for cardiac probes, representing a shift from two-hour chemical processes to two-minute automated cycles in medical device reprocessing.

9:51

Feb 4, 2026

02/04/26 - Foundation Model Consolidation in Abdomen CT, Medicare Reimbursement for Lung Nodule Characterization, Autonomous Pre

This episode covers FDA clearances across imaging platforms in February twenty twenty-six, including RevealDx’s lung nodule characterization software with activated Medicare reimbursement, Nanox’s TAP2D enhancement for tomosynthesis systems, GE HealthCare’s Allia Moveo intervention imaging and MIM LesionID Pro for automated tumor burden analysis, and Aidoc’s comprehensive foundation model for multi-condition abdomen CT detection. The briefing concludes with an examination of Doctronic’s autonomous prescription renewal system in Utah, which operates without direct clinician input and claims exemption from FDA oversight under the practice of medicine doctrine, illustrating unresolved jurisdictional questions in AI-driven clinical decision-making.

11:55

Feb 3, 2026

02/03/26 - FDA Regulatory Boundary Shifts for LLM CDS, Foundation Model Multi-Indication Clearances, Helium-Free MRI Infrastruct

This episode examines the FDA’s updated guidance on large language model based clinical decision support and a proposed streamlined pathway for radiology AI vendors, Aidoc’s fourteen indication clearance on the CARE foundation model platform, HeartLung’s opportunistic screening clearance, and Google’s release of MedGemma one point five with expanded multimodal imaging capabilities. It also covers GE HealthCare’s Allia Moveo interventional imaging system, Siemens Healthineers’ helium free one point five tesla MRI, Medtronic’s expanded insulin delivery integration with Abbott’s Instinct sensor for Medicare beneficiaries, and recent platform partnerships and funding developments across radiology and point of care ultrasound infrastructure.

11:22

Jan 30, 2026

01/30/26 - FDA CDS Enforcement Discretion, Hardware-Agnostic Cardiac AI Clearances, CMS TEMPO Pre-Clearance Pilot

This episode examines FDA’s twenty twenty six Clinical Decision Support guidance updates addressing enforcement discretion for single-recommendation outputs and LLM summarization tools, new clearances for hardware-agnostic AI platforms detecting heart murmurs across multiple digital stethoscope brands, GE HealthCare’s automated PSMA imaging segmentation for prostate cancer burden analysis, and CMS’s TEMPO pilot program allowing pre-clearance prescribing of digital therapeutics tied to outcomes data collection within the ACCESS payment model. The briefing covers structural shifts in how regulatory pathways interact with reimbursement frameworks and vendor-independent AI deployment models.

11:47

Jan 23, 2026

01/23/26 - ARPA-H Cardiovascular AI Agent Pathway, OneMedNet Regulatory Data Clearance, Health Tech IPO Valuation Discount

This episode examines the first federal regulatory pathway for generative AI in cardiovascular care through ARPA-H’s ADVOCATE program, which funds autonomous clinical agents designed for FDA authorization within thirty-nine months. The briefing covers OneMedNet’s role in supporting the first five ten k clearance using regulatory-grade multimodal datasets, analyzes the valuation discount applied to six recently public health tech companies trading below emerging cloud software multiples despite comparable profitability, and reviews the FDA’s new risk classification framework that separates information tools from diagnostic devices. The episode concludes with CMS Innovation Center pilots testing reimbursement models for AI-assisted diagnosis and remote patient monitoring.

7:59

Jan 17, 2026

01/17/26 - HeartLung AI-CVD Opportunistic Screening Platform, Leadoptik Last Inch Assessment Biopsy Imaging, BD EnCor EnCompass

This episode examines three FDA five ten kay clearances demonstrating distinct device integration strategies. HeartLung’s AI-CVD platform extracts ten measurement domains from forty million routine CT scans annually without workflow modification. Leadoptik’s Last Inch Assessment system embeds silicon metamaterial depth imaging directly into biopsy tools with fifty times greater resolution than current modalities. BD’s EnCor EnCompass system provides cross-modality compatibility across stereotactic, ultrasound, and MRI guided breast biopsy procedures through adjustable vacuum strength and three sixty degree sampling capability. Each clearance addresses procedural economics and reimbursement pathways through different technical architectures for clinical AI integration.

9:34

Jan 15, 2026

01/15/26 - FDA Wearable Wellness Policy Update, Medical AI Governance Structural Proposals, Robotic Cochlear Implants and Dental

This episode examines FDA’s January sixth general wellness policy update clarifying wearable health technology regulation in response to enforcement actions, analyzes University of Michigan Law School proposals to shift medical AI oversight away from individual clinician review toward independent system evaluation, and covers new FDA clearances for IotaMotion’s robotic assisted cochlear implant system in pediatric patients and Pearl’s Second Opinion dental AI platform for panoramic radiograph analysis. The briefing concludes with joint FDA and EMA guiding principles establishing good AI practice standards for pharmaceutical development workflows across both regulatory jurisdictions.

11:05

Jan 14, 2026

01/14/26 - AliveCor KAI 12L Expands to 39 Cardiac Determinations, Imbio Multi-Organ Opportunistic Screening, ASUS Cross-Platform

This episode examines AliveCor’s FDA clearance expansion to thirty nine cardiac determinations on the KAI twelve L platform, including peer reviewed data showing twenty nine percent acquisition time reductions and Medicare reimbursement approval for hospital outpatient settings. The briefing covers Imbio’s EmpowerCTA plus clearance for simultaneous cardiovascular, liver, and musculoskeletal screening from single noncontrast chest CT scans, ASUS LU eight hundred’s cross platform handheld ultrasound deployment supporting Android, Chrome, iOS, and Windows systems, and the structural shift toward AI driven protocol automation and risk based validation in clinical trial operations driven by regulatory acceptance of machine generated compliance evidence.

9:41

Jan 13, 2026

01/13/26 - HeartLung AI-CVD FDA Clearance, Utah Prescription Refill Sandbox, Cell Therapy Manufacturing Flexibility

This episode examines HeartLung Corporation’s FDA five ten k clearance for opportunistic cardiovascular risk extraction from routine CT scans, Utah’s regulatory sandbox authorizing AI driven prescription refills for one hundred ninety medications under physician review, and the FDA’s new flexibility for cell and gene therapy manufacturing quality requirements. The briefing covers implementation costs between three hundred thousand and five hundred thousand dollars per algorithm, clarifies enforcement discretion for low risk clinical decision support tools, and reviews how regulatory frameworks are shaping deployment economics across health systems with varying institutional resources.

11:50

Jan 12, 2026

01/12/26 - Asymmetric FDA and CMS Enforcement, HeartLung Opportunistic Screening Clearance, MRM Health IND Approval

This episode examines divergent federal regulatory frameworks creating asymmetric enforcement pressure across AI applications in healthcare, with the FDA reducing barriers for diagnostic tools while CMS and OIG increase scrutiny of AI-generated documentation and billing practices. Coverage includes HeartLung Corporation’s FDA clearance for multisystem opportunistic screening from existing chest CT workflows, MRM Health’s investigational new drug approval for a Phase 2B ulcerative colitis trial, and capital concentration data showing AI representing forty six percent of healthcare technology investment despite overall market contraction. The briefing details operational governance requirements for healthcare organizations navigating simultaneous deregulation in diagnostics and heightened compliance risk in revenue cycle applications.

9:39

Jan 11, 2026

01/11/26 - PDS Biotech PFS Endpoint Alignment, Plus Therapeutics LM Pivotal Guidance, Rapport RAP-219 Phase 3 Clearance

This episode examines four recent FDA regulatory interactions that advanced clinical development pathways through surrogate endpoint validation and trial design optimization. Coverage includes PDS Biotech’s VERSATILE-003 amendment prioritizing progression-free survival for accelerated approval in HPV16-positive head and neck cancer, Plus Therapeutics’ Type B meeting guidance on overall survival endpoints for rhenium Re 186 obisbemeda in leptomeningeal metastases, Rapport Therapeutics’ Phase 3 clearance for RAP-219 in focal onset seizures, and 4Moving Biotech’s IND clearance enabling US expansion of the INFLAM MOTION trial for intra-articular GLP-1 therapy in knee osteoarthritis. The briefing highlights evolving FDA standards for accelerated approval structures, surrogate biomarker qualification, and multi-jurisdictional trial execution across oncology, neurology, and rare disease programs.

12:39

Jan 10, 2026

01/10/26 - OpenAI GPT 5.2 HIPAA Deployment, HeartBeam Remote Cardiac Monitoring Clearance, OTP-01 Dual Target Oncology IND

This episode examines OpenAI’s January eighth deployment of GPT five point two models across six major health systems under Business Associate Agreements, including validation methodology through more than two hundred sixty physicians reviewing six hundred thousand outputs. The briefing covers the FDA clearance of HeartBeam’s three dimensional to twelve lead ECG synthesis software for remote arrhythmia assessment, supported by eighty two global patent publications. Additional reporting addresses the IND clearance for OTP zero one, a first in class dual paratopic monoclonal antibody targeting PD one and VEGFR two in solid tumors, and BrightHeart’s eleven million euro Series A to commercialize prenatal congenital heart defect detection AI showing fifteen point three percent sensitivity improvement. The episode concludes with analysis of clinical trial infrastructure shifts driven by AI enabled quality monitoring, remote cognitive assessment platforms, and adaptive measurement strategies addressing rare disease evidence requirements and GLP one retention challenges.

12:23

Jan 9, 2026

01/09/26 - FDA Elevates Explainability to Regulatory Prerequisite, Expands CDS and Wellness Exclusions, Five Ten K Clearances Ac

This episode examines the FDA’s January sixth final guidance on clinical decision support exclusions under Section five twenty o one E, which now explicitly ties insufficient transparency to automation bias and establishes that opaque models will not satisfy criterion four regardless of labeling. January seventh guidance documents expanded wellness product boundaries to include blood pressure and glucose monitoring in wearables and reversed the prior position that software providing a sole medical recommendation would trigger device status. Clearances covered include AccurKardia’s AccurECG two point zero for automated arrhythmia classification, Welldoc’s five ten K submission for continuous glucose monitor informed prediction in non insulin dependent type two diabetes, Etiometry’s tenth clearance for cybersecurity and waveform integration, and Siemens Healthineers’ seventy centimeter Magnetom Flow MR platform with helium free cooling technology. The episode concludes with the formal start of user fee reauthorization negotiations ahead of the September twenty twenty seven deadline, which provides a legislative vehicle for potential policy changes across FDA review processes and post market monitoring obligations.

9:25

Jan 8, 2026

01/08/26 - FDA Wellness Device Exemptions, Utah Autonomous Prescription Renewals, Ceribell LVO Stroke Breakthrough

This episode examines four regulatory and operational developments shaping clinical AI deployment. We cover FDA’s announcement exempting low-risk wellness devices from premarket review, Utah’s first-in-nation AI prescription renewal program operating without physician oversight, Ceribell’s breakthrough designation for in-hospital stroke detection using EEG-based algorithms, and expanded clearance for AI-guided echocardiography extending to novice providers. The briefing also reviews Vi’s operational data from one hundred ninety million patient interactions, documenting efficiency gains in scheduling, documentation, and workflow automation across healthcare, biopharma, and wellness sectors. These developments illustrate how regulatory frameworks are adapting to AI execution layers while clinical decision authority shifts across different provider skill levels and care settings.

14:38

Jan 7, 2026

01/07/26 - FDA Eases CDS Market Entry, February ISO 13485 Compliance Deadline, RapidAI Neurovascular Clearances

This episode examines the FDA’s policy shift allowing clinical decision support software to bypass premarket review, the convergence of three regulatory deadlines in February 2026 that impose manufacturer-grade compliance on radiology groups customizing AI workflows, and new clearances for RapidAI’s neurovascular imaging modules, BrainSpace’s adaptive hydrocephalus management system, and UltraSight’s multi-platform cardiac ultrasound program. The briefing details how HTI-1 transparency requirements, ISO 13485 quality management standards, and Recovery Audit Contractor enforcement are reshaping operational accountability for health systems deploying AI-enabled clinical interventions.

13:05

Jan 6, 2026

01/06/26 - Mebufotenin Inhalation Clears Hold, Spine Navigation Converges, Microneedle Oncology Advances

This episode examines the FDA’s clearance of GH Research’s clinical hold for GH001, a mebufotenin inhalation therapy that demonstrated fifteen point five MADRS reduction and seventy-three percent six-month remission in Phase 2b treatment-resistant depression trials. The briefing covers December twenty twenty-five neurology regulatory actions including Tris Pharma’s oxybate NDA acceptance, Prilenia’s five-hundred-patient ALS trial clearance, and inebilizumab approval for myasthenia gravis, alongside Sanofi’s tolebrutinib Phase 3 miss in primary progressive MS and Johnson & Johnson’s expanded embolic indication. Spine device clearances from BrainLab, Augmedics, Proprio, and others map sector convergence on additive manufacturing and augmented reality navigation platforms. The episode concludes with Medicus Pharma’s completion of enrollment in a ninety-patient Phase 2 trial of a doxorubicin-containing dissolvable microneedle array for basal cell carcinoma, with topline results expected in Q1 twenty twenty-six and multi-jurisdictional expansion underway.

11:17

Jan 4, 2026

01/04/26 - Arovella CAR-iNKT IND Filing, GH Research Clinical Hold Update, Harrison.ai 510(k) Exemption Petition

This episode examines four regulatory pathways across therapeutic and diagnostic development. Coverage includes Arovella Therapeutics’ IND filing for ALA-101, an allogeneic CAR-iNKT therapy targeting CD19-positive hematologic malignancies; GH Research’s scheduled investor update on the clinical hold for GH001 in treatment-resistant depression; Intelligent Bio Solutions’ ten million dollar private placement funding its FDA 510(k) submission for non-invasive fingerprint drug screening; and a citizen petition filed by Harrison.ai requesting partial 510(k) exemptions for radiology AI manufacturers with prior clearances. The briefing details procedural timelines, capital structures, and classification-specific regulatory mechanisms shaping product development and commercialization pathways.

11:20

Jan 3, 2026

01/03/26 - Harrison.ai Cleared Triage vs Unapproved Generative, NTAP Reimbursement Economics, Accelerated Radiology AI Pathway P

This episode examines the regulatory boundaries between Harrison.ai’s twelve FDA cleared imaging triage modules and its unapproved generative radiology copilot, the operational impact of CMS New Technology Add on Payment status and Series C capital on U.S. market entry, and emerging governance frameworks including the proposed Accelerated Radiology AI Pathway, the FDA’s first qualified AI drug development tool for MASH trials, IQVIA’s five pharmacovigilance governance strategies, and the Sodium Dichloroacetate rare disease petition that tests accelerated approval mechanisms when trial enrollment faces structural barriers.

11:17

Jan 2, 2026

01/02/26 - Neurology Pipeline Decisions, Women's Health Regulatory Clearances, Enterprise AI Deployment Economics

This episode examines high impact neurology regulatory decisions scheduled for the first half of twenty twenty six, including tolebrutinib for non-relapsing secondary progressive multiple sclerosis, GTx one oh four for aneurysmal subarachnoid hemorrhage, tavapadon for Parkinson disease, and once weekly subcutaneous lecanemab for early Alzheimer disease. It reviews FDA authorizations for women’s health therapeutics and diagnostics in twenty twenty five, including gepotidacin, Sonio Suspect, Visby Medical’s at home STI test, and the Teal Wand for cervical cancer screening. The briefing covers the operational shift from AI experimentation to enterprise scale deployment in healthcare, focusing on ambient listening integration, revenue cycle automation, and agentic AI in clinical workflows. It concludes with BioAtla’s forty million dollar special purpose vehicle transaction with GATC Health and Inversagen AI to advance ozuriftamab vedotin into registrational Phase Three trials for oropharyngeal squamous cell carcinoma.

10:34

Jan 1, 2026

04/15/26 - FDA Lifecycle Guidance for AI Devices, Administrative Automation Capital Concentration, AI-Discovered Antifibrotic in

This episode examines the operational and regulatory landscape of clinical AI deployment in twenty twenty-five. We cover the FDA’s Total Product Life Cycle guidance for AI-enabled medical devices, the concentration of venture capital in administrative automation and clinical documentation tools, the deployment gap between large health systems and smaller providers in clinical decision support, and the first AI-discovered drug compound to advance into phase 2a trials. The briefing also addresses brain-computer interface production scaling and the reimbursement bottlenecks constraining digital therapeutics despite regulatory approval. Listeners gain a structured view of where capital, regulatory clarity, and operational adoption are converging in healthcare AI infrastructure.