AI in Medicine - curated summaries making complex issues easy to understand
Mike Rawson
▶ Webplayer- Health
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Mike Rawson
▶ WebplayerAI in Medicine - Smart Summaries is a daily podcast for clinicians, health-system leaders and medtech, pharma and digital-health teams. Each episode unpacks one important public document on artificial intelligence in healthcare, such as FDA, EMA, MHRA, WHO or NHS guidance, OECD and World Economic Forum reports, or an open-access peer-reviewed review, in a clear 15 to 20 minute conversation. Topics include clinical AI and decision support, medical imaging and radiology AI, large language models (LLMs) and generative AI in clinical practice, AI-enabled medical devices and their regulation, the EU AI Act, drug discovery and clinical trials, digital health and wearables, health-system...
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Nov 13, 2026 · 12:27
This episode unpacks the FDA 510(k) summary for DeepHealth ProstateAI, a radiological software device developed by Quantib BV. We explore how the deep learning tool assists…
Nov 13, 2026 · 15:04
We unpack a 2026 Accenture report on why intelligent medical devices are struggling to scale across healthcare systems. We explore the massive disconnect between medtech's data…
Nov 12, 2026 · 14:44
We unpack the FDA's 510(k) summary for Milvue's TechCare Trauma, an AI tool cleared to detect fractures and elbow joint effusions on plain X-rays. Listeners will learn how the…
Nov 12, 2026 · 17:29
Health systems are rushing to deploy AI tools that promise massive efficiency gains, but what happens when bedside nurses push back? This episode unpacks a comprehensive…
Nov 11, 2026 · 10:38
We unpack the FDA 510(k) summary for the SafeBeat Rx App, a software tool that uses machine learning to measure ECG intervals and suggest antiarrhythmic drug dosing. We discuss…
Nov 11, 2026 · 16:30
We unpack an urgent American Medical Association resolution pushing back against claims that unassisted clinical AI is superior to human doctors. The AMA outlines strict demands…
Nov 10, 2026 · 18:36
The American Medical Association is pushing back against health systems using AI efficiency gains to justify higher patient quotas and shortened appointments. We unpack a 2026…
Nov 10, 2026 · 12:44
In this Company Spotlight, we dive into the FDA 510(k) clearance for Median Technologies' eyonis LCS 1.1. We unpack how this AI tool aims to go beyond basic nodule detection by…
Nov 9, 2026 · 14:56
The UK Department of Health and Social Care is rethinking how AI is regulated in medicine, aiming to make the NHS the most AI-enabled system in the world. We unpack their new…
Nov 9, 2026 · 11:47
We unpack the FDA 510(k) summary for Circle Cardiovascular Imaging's cvi42 Coronary Plaque Software Application. This episode explores the device's machine learning validation…
Nov 8, 2026 · 13:02
We unpack the FDA 510(k) summary for Keya Medical's DEEPVESSEL Plaque, a cloud-based software for analyzing coronary CTA scans. The episode explores how the device uses deep…
Nov 8, 2026 · 23:02
This episode unpacks a new conceptual framework for integrating clinical reasoning, pathophysiology, and AI in critical care. We explore why standard AI algorithms falter in…
Nov 7, 2026 · 14:09
This Company Spotlight dives into the FDA 510(k) summary for Apple's Hypertension Notification Feature. We unpack how the software opportunistically analyzes wrist-based PPG data…
Nov 7, 2026 · 19:59
The WHO Regional Office for Europe has just released a massive roadmap for health AI from 2026 to 2033. We unpack its strict new mandates for legal liability, compensating…
Nov 6, 2026 · 17:30
Generative AI could unlock massive economic value for life sciences, but only 5% of companies are seeing the benefits. Maya and Sam break down a new IQVIA white paper on how…
Nov 6, 2026 · 12:27
We unpack the FDA 510(k) summary for Methinks CTA Stroke, an AI triage tool cleared to detect large vessel occlusions on CT angiograms. We explore its performance data, the…
Nov 5, 2026 · 16:46
NICE recently evaluated AI tools designed to opportunistically detect vertebral fragility fractures on routine scans. We explore why 5 were approved for evidence generation, why…
Nov 5, 2026 · 12:53
We unpack the FDA 510(k) summary for GuideAI's Vascular Assist Occlusion Triage (VAOT) software. We explore its clinical targets in the lower extremities, the technical workflow,…
Nov 4, 2026 · 13:37
In this episode, we unpack the FDA 510(k) summary for Caristo Diagnostics' CaRi-Plaque software. We explore how this web-based device leverages remote human operators and…
Nov 4, 2026 · 20:03
Routine coronary CT scans are getting an AI-driven upgrade. We explore a paper detailing how artificial intelligence analyzes pericoronary adipose tissue to act as a dynamic…
Nov 3, 2026 · 17:14
Health Canada has released its pre-market guidance for machine learning-enabled medical devices, outlining how developers must validate, document, and license AI tools. Maya and…
Nov 3, 2026 · 11:55
We unpack the FDA 510(k) summary for Imvaria's Fibresolve with PCCP. This software-only device analyzes lung CT scans as an adjunct for diagnosing idiopathic pulmonary fibrosis…
Nov 2, 2026 · 14:18
In this episode, we unpack the FDA 510(k) summary for Cercare Medical's CMN Capillary Function with Oncology Virtual Expert. We explore how this software combines structural…
Nov 2, 2026 · 15:17
Health systems are rushing to deploy ambient AI scribes to combat clinician burnout. This episode unpacks a new framework explaining why evaluating these tools solely on minutes…
Nov 1, 2026 · 12:15
We unpack the FDA 510(k) summary for the HistoSonics Planning Tool, cleared in May 2026. This episode explores how the standalone software uses machine learning to segment organs…
Nov 1, 2026 · 15:26
A 2026 systematic review in the Journal of medical Internet research reveals critical reporting gaps in randomized controlled trials of generative AI. Maya and Sam unpack why…
Oct 31, 2026 · 11:38
This episode examines the FDA 510(k) summary for Iterative Health's SKOUT system, a computer-aided detection tool that places a blue bounding box around potential colorectal…
Oct 31, 2026 · 19:12
The American Medical Association's October 2026 issue brief tackles the medical community's biggest fear regarding artificial intelligence: liability. This episode explores the…
Oct 30, 2026 · 17:28
IQVIA's white paper outlines a strategic framework for responsible AI governance in regulated healthcare systems. The hosts unpack why disabling self-learning features is often…
Oct 30, 2026 · 13:33
We unpack the FDA's 510(k) summary for Qure.ai's qER-CTA, an AI triage tool designed to detect large vessel occlusions on head CT scans. We explore its clinical performance data,…
Oct 29, 2026 · 12:21
This episode unpacks the FDA 510(k) summary for Therapixel's MammoScreen 5, an AI tool cleared to assist radiologists in reading mammograms. Listeners will learn how the software…
Oct 29, 2026 · 19:37
Australia's Therapeutic Goods Administration is consulting on whether to close a regulatory loophole that allows certain digital mental health tools to bypass medical device…
Oct 28, 2026 · 14:41
The FDA has released a highly detailed draft guidance outlining exactly what manufacturers must include in marketing submissions for AI-enabled medical devices. We unpack the…
Oct 28, 2026 · 13:38
In this episode, we unpack the FDA 510(k) summary for Cleerly LABS (v2.0), an AI tool for analyzing cardiac CT scans. We explore how it separates deep learning vessel…
Oct 27, 2026 · 13:08
We unpack the FDA 510(k) summary for iRhythm's ZEUS Platform, a software system that uses deep learning to process and analyze ECG data from wearable cardiac monitors. We discuss…
Oct 27, 2026 · 15:53
A new scoping review analyzes 92 studies on machine learning for surgical skill assessment. Maya and Sam unpack the massive gap between high-performing algorithms in the lab and…
Oct 26, 2026 · 15:53
How do you regulate a conversational AI that adapts to every patient? We unpack a landmark 2026 review outlining the MHRA and NICE's approach to digital mental health technology.…
Oct 26, 2026 · 13:13
We dive into the FDA 510(k) summary for TriVerity by Inflammatix, a test that uses host-response mRNA to evaluate emergency department patients with suspected sepsis. Listeners…
Oct 25, 2026 · 14:14
This episode unpacks the FDA 510(k) clearance summary for Alife Health's Embryo Predict, an AI software tool designed to help embryologists select IVF embryos for transfer. Maya…
Oct 25, 2026 · 19:12
When a severe stroke occurs, rapid transfer to a specialized center is vital, but advanced imaging is often unavailable off-hours or in rural settings. We unpack a 2026…
Oct 24, 2026 · 13:28
We unpack the FDA 510(k) summary for Scopio Labs' X100 and X100HT systems with their modified Full Field Peripheral Blood Smear Application. The document details how the device…
Oct 24, 2026 · 21:08
This systematic review and meta-analysis evaluates whether AI and machine learning models outperform conventional clinical triage in emergency care settings. We explore the high…
Oct 23, 2026 · 13:23
We unpack the FDA 510(k) clearance summary for the EFAI Ersuite CT Appendicitis Assessment System. Discover how this AI triage tool performed in a 300-case retrospective study,…
Oct 23, 2026 · 16:39
The FDA recently cleared Qure.ai's qCT Lung (v1.0), an AI tool designed to detect, characterize, and quantify lung nodules in adult screening CT scans. Maya and Sam unpack the…
Oct 22, 2026 · 13:01
We unpack the FDA 510(k) summary for EchoGo Amyloidosis 1.0, an AI screening tool by Ultromics designed to detect cardiac amyloidosis from routine echocardiograms. We break down…
Oct 22, 2026 · 17:41
We unpack a systematic review investigating if AI decision support genuinely improves primary care or just creates more alert fatigue. Listeners will learn where these systems…
Oct 21, 2026 · 13:51
We unpack the FDA 510(k) summary for the Clarius Ejection Fraction AI, a machine learning tool that automates left ventricular ejection fraction measurements directly on handheld…
Oct 21, 2026 · 16:25
The European Commission released its first formal assessment on whether to expand the list of prohibited and high-risk AI under the AI Act. We unpack the 547 stakeholder…
Oct 20, 2026 · 15:41
Millions of patients receive intravenous therapy every day, yet the infusion pumps delivering these critical medications remain highly vulnerable to human error. This episode…
Oct 20, 2026 · 16:23
We unpack the FDA 510(k) summary for Cosmo AI's GI Genius Module 300 and ColonPRO US software. We explore its 88.07% lesion-based sensitivity and the newly cleared multicontainer…
Oct 19, 2026 · 17:04
The FDA is seeking input on a new pilot program exploring how artificial intelligence can optimize early-phase clinical trials. Maya and Sam unpack the agency's goals—from…
Oct 19, 2026 · 12:05
We unpack the FDA 510(k) summary for SubtleHD-CT, an AI software designed to enhance CT scans in the background. We explore the phantom testing parameters, the retrospective…
Oct 18, 2026 · 14:59
We dive into the FDA 510(k) summary for iSchemaView's Rapid Aortic Measurements, an AI tool designed to evaluate aortic and iliac arteries. We explore its performance data,…
Oct 18, 2026 · 15:16
This episode unpacks an executive case note from The AI Institute arguing that hospital boards must approve clinical AI and its operating environment as a single, joint decision.…
Oct 17, 2026 · 13:55
In this company spotlight, we break down the FDA 510(k) summary for Volta Medical's Volta AF-Xplorer II, cleared in September 2025. We explore how this AI tool uses deep learning…
Oct 17, 2026 · 17:41
The OECD's 2026 report outlines how healthcare can move AI from isolated pilot projects to enterprise-scale deployment. Listeners will learn the critical data, governance, and…
Oct 16, 2026 · 12:59
In this Company Spotlight, we explore the FDA 510(k) summary for Sonio Suspect, an AI tool designed to detect abnormal fetal ultrasound findings. We unpack how Sonio transitioned…
Oct 16, 2026 · 14:06
NICE recently published guidance on 10 artificial intelligence technologies designed to detect or characterise colorectal polyps. While 6 tools have been conditionally…
Oct 15, 2026 · 15:34
How do you evaluate a medical technology that constantly changes after deployment? Maya and Sam unpack a new report from the University of Sheffield's Decision Support Unit on…
Oct 15, 2026 · 13:04
We unpack the FDA 510(k) clearance for Anumana's WatchMate Software, a deep-learning tool that reconstructs 3D models of the left atrial appendage from standard 2D ultrasound.…
Oct 14, 2026 · 19:43
We unpack the Stanford AI Index 2026 Medicine chapter to explore why AI is acing medical exams but still struggling to translate into prospective clinical trial evidence. We dive…
Oct 14, 2026 · 12:09
We unpack the FDA 510(k) summary for Bunkerhill Contrast CAC, an AI tool cleared to opportunistically detect and quantify coronary artery calcium on routine contrast-enhanced…
Oct 13, 2026 · 16:59
The FDA is asking the healthcare industry how to regulate generative AI medical devices. We unpack their proposed competency-based approach, which evaluates AI less like software…
Oct 13, 2026 · 15:10
We unpack the FDA 510(k) summary for Tyto Insights for Wheeze Detection (with PCCP). Listeners will learn how this over-the-counter AI software analyzes lung sounds, the real…
Oct 12, 2026 · 17:06
The AMA just surveyed nearly 1,700 physicians on their real-world use of augmented intelligence. We unpack why professional adoption has doubled, the massive hidden wave of…
Oct 12, 2026 · 12:13
We unpack the FDA 510(k) summary for Eko Health's EFAST software, which brings transformer-based AI to the digital stethoscope. Listeners will learn how the cloud-based system…
Oct 11, 2026 · 16:24
We dive into the FDA's recent clearance of AiTiALVSD, an AI tool that predicts left ventricular systolic dysfunction from a standard 12-lead ECG. We break down the clinical…
Oct 11, 2026 · 16:21
We unpack a critical Stanford and UC Berkeley report advising California on its new Transparency in Frontier AI Act (TFAIA). Discover why current legal definitions of AI risk are…
Oct 11, 2026 · 14:30
NICE weighs in on 4 AI technologies designed to speed up echocardiography for heart failure diagnosis. Despite incredible claims of time savings, the agency stops short of…
Oct 11, 2026 · 14:00
We unpack the FDA 510(k) summary for icobrain aria by icometrix, an AI tool cleared to help radiologists detect brain swelling and bleeding in Alzheimer's patients. We explore…
Oct 10, 2026 · 20:46
MedTech Europe's position paper outlines a critical juncture for medical device regulation in the EU. We unpack their proposed amendments to the MDR and IVDR, focusing on how AI…
Oct 10, 2026 · 15:12
The CDC just released a blueprint for how field epidemiology training programs should handle AI. We explore a fascinating case study where AI actually harms an outbreak…
Oct 10, 2026 · 16:07
The World Bank takes a deep dive into how artificial intelligence is actually being used in medical schools across Viet Nam. Maya and Sam unpack the massive gap between student…
Oct 10, 2026 · 11:08
We unpack the FDA clearance letter for ArteraAI Breast, a software-only device designed to predict 5- and 10-year metastasis risks from standard pathology slides. We explore the…
Oct 9, 2026 · 17:52
The World Economic Forum has released a new framework on how Asia is deploying AI. We explore why rapid AI adoption is failing to translate into sustained value for many…
Oct 9, 2026 · 17:20
MedTech and Pharma companies are using AI to speed up regulatory submissions, but many are finding that faster output is actually leading to more rejections. This episode unpacks…
Oct 9, 2026 · 14:59
The FDA recently cleared TumorSight Risk, an AI software that analyzes MRI and clinical data to predict the 5- and 10-year recurrence risk for breast cancer patients. Maya and…
Oct 9, 2026 · 13:50
DeepHealth’s Saige-Dx recently received FDA 510(k) clearance for analyzing digital breast tomosynthesis (DBT) mammograms. We unpack the public summary to see how this AI tool…
Oct 8, 2026 · 17:20
The FDA recently cleared the Artificial Intelligence Renal Assessment AIRA Version 1 for measuring kidney volume from CT scans. We break down the device's technical workflow, its…
Oct 8, 2026 · 17:34
This episode explores a pivotal paper on the shift from narrow AI tools to feedback-driven AI agents in oncology. We discuss how these systems orchestrate multimodal data, the…
Oct 8, 2026 · 22:48
Obstructive sleep apnea affects an enormous global population, but traditional sleep studies are expensive and inaccessible. Maya and Sam unpack a new meta-analysis from the…
Oct 8, 2026 · 18:35
We dive into a comprehensive systematic review examining the real-world effectiveness, safety, and workflow burden of LLM-based medical report generation. Listeners will learn…
Oct 8, 2026 · 11:12
We unpack the FDA 510(k) summary for Galen Second Read by Ibex Medical Analytics. This episode explores how this cloud-hosted AI acts as a background safety net for pathologists,…
Oct 7, 2026 · 13:22
This episode unpacks the FDA 510(k) summary for Brainomix 360 Hyperdensity, an AI tool designed to automatically flag and measure intracranial hyperdensities on CT scans. We…
Oct 7, 2026 · 16:02
A new World Economic Forum white paper argues that health systems are evaluating AI backward. Procurement teams buy AI for efficiency, while clinicians and patients bear the…
Oct 7, 2026 · 17:57
Health systems are eager to adopt AI for aging populations, but does the technology actually save money? We unpack a scoping review of 40 economic evaluations to reveal why most…
Oct 7, 2026 · 16:53
This episode unpacks a comprehensive review spanning ten years of AI in screening mammography. Listeners will learn why pooled accuracy figures mask deep implementation…
Oct 7, 2026 · 18:40
The UK government has officially accepted all 44 recommendations from the National Commission into the Regulation of AI in Healthcare. In this episode, Maya and Sam unpack the…
Oct 7, 2026 · 16:41
The FDA recently released a framework detailing how to use digital health technologies and AI to capture clinical trial outcomes. We explore the critical differences between…
Oct 6, 2026 · 14:22
We unpack the FDA 510(k) summary for Aidoc's BriefCase-Triage, a cloud-based AI tool cleared in May 2026. Listeners will learn how it performs in flagging large and medium vessel…
Oct 6, 2026 · 17:50
The European Medicines Agency has released its 2025 AI Observatory report, revealing how regulators are deploying 61 internal AI use cases to evaluate pharmaceutical submissions.…
Oct 6, 2026 · 11:54
We unpack the FDA 510(k) clearance summary for Viz Subdural+, an AI tool designed to automatically label and measure collections in the subdural space from brain CT scans.…
Oct 6, 2026 · 17:42
The UK Government has released a sweeping blueprint for the future regulation of AI in healthcare, aimed at moving away from static, one-off approvals. Listeners will learn how…
Oct 6, 2026 · 18:25
The FDA has granted De Novo classification to Spectral MD's DeepView AI System, a software that predicts burn wound healing. Maya and Sam unpack the device's indications, the…
Oct 6, 2026 · 19:58
We unpack the MHRA's AI Airlock Sandbox Phase 2 Programme Report to explore how the UK regulator is pressure-testing rules for adaptive algorithms. From generative AI drifting…
Oct 5, 2026 · 17:38
The FDA has granted 510(k) clearance to the Bayesian Health Sepsis Flagging Device, a continuous AI monitor that uses 115 electronic health record inputs to predict sepsis risk.…
Mar 25, 2026 · 22:52
This comprehensive review examines the rapid integration of artificial intelligence and robotics within modern surgical practice. Research indicates that these advanced systems…
Mar 25, 2026 · 25:10
This academic review examines the evolution of AI-enabled home healthcare technologies , focusing on how medical wearables and digital diagnostics can improve chronic disease…
Mar 25, 2026 · 26:49
These sources provide a comprehensive review of AI-driven wearable bioelectronics and their transformative role in modern digital healthcare . The text details how advanced…
Mar 25, 2026 · 22:30
This academic review examines the transformative role of artificial intelligence within modern healthcare, highlighting its capacity to improve diagnostic accuracy, drug…
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