Healthcare Technology

Spotlight Monebo Clears FDA for Kinetic ECG Software Library Oct 31, 20268 min read Read the story Spotlight Deep Reasoning AI Secures FDA Clearance for NeuroDR Oct 30, 20267 min read Read the story Spotlight Elucid Wins FDA Clearance for Its FFR-IQ Software Oct 27, 20267 min read Read the story Spotlight RIVANNA Wins FDA Clearance for BoneEnhance AI Oct 26, 20266 min read Read the story Spotlight Coreline Soft Wins 13th FDA Clearance for Aortic AI Oct 24, 20266 min read Read the story Spotlight Eko Health Launches CORE 300 Hybrid AI Stethoscope Oct 24, 20266 min read Read the story Spotlight NeuroXT Clears FDA for Alzheimer's Risk AI Tool Oct 23, 20266 min read Read the story Guidance & Policy FDA Finalizes Guidance on Drug Companion Apps 6 min read Read the story For Physicians FDA Clears AI Tool to Score Breast Cancer Recurrence Oct 21, 20269 min read Read the story Devices & Diagnostics FDA Clears Twiist Pump for Type 2 Diabetes Oct 20, 20266 min read Read the story Spotlight SimBioSys Earns FDA Clearance for TumorSight Risk Oct 18, 20266 min read Read the story For Physicians FDA Flags Edwards SAPIEN M3 Delivery System After Death Oct 16, 20268 min read Read the story Guidance & Policy MHRA Publishes Strategy 2030 for the AI Era Oct 16, 20266 min read Read the story For Physicians FDA Clears Neurora AI Tool for Autism Diagnosis Oct 14, 20268 min read Read the story Devices & Diagnostics WHO Expands Device Prequalification to Condoms, IUDs Oct 14, 20266 min read Read the story For Physicians FDA Clears Patient App for Abbott's CardioMEMS Monitor Oct 13, 20269 min read Read the story Spotlight HeartBeam Wins FDA Breakthrough Status for Heart Attacks Oct 12, 20267 min read Read the story Spotlight Wellysis Wins FDA Clearance for S-Patch CardioAI Oct 11, 20266 min read Read the story Devices & Diagnostics FDA Links Philips Lumify Ultrasound Bug to Four Deaths Oct 11, 20265 min read Read the story Spotlight Argus Cognitive Earns FDA Clearance for Neurora Oct 10, 20265 min read Read the story For Physicians TTFields Device Now Part of Pancreatic Cancer Care Oct 8, 20269 min read Read the story For Physicians FDA Clears AI to Quantify Liver, Visceral Fat on MRI Oct 7, 202610 min read Read the story Guidance & Policy UK Backs All 44 Recommendations for NHS AI Oct 7, 20266 min read Read the story Spotlight AIRS Medical Clears FDA 510(k) for Body-Fat MRI AI Oct 6, 20267 min read Read the story Spotlight UltraSight Raises $24M to Scale AI Cardiac Ultrasound Oct 4, 20266 min read Read the story Guidance & Policy FDA's CDRH Flags AI and Surgical Robots for FY2027 Oct 4, 20264 min read Read the story Devices & Diagnostics FDA Clears Medtronic's Affera Prism-2 Mapping Software Oct 1, 20267 min read Read the story Devices & Diagnostics FDA Clears Ceribell's New EEG Monitoring Tools Oct 1, 20266 min read Read the story For Physicians FDA Clears Tempus AI Tool to Flag Mitral Regurgitation Sep 30, 20268 min read Read the story Spotlight Aidoc Wins Third FDA Breakthrough Nod for X-Ray AI Sep 30, 20267 min read Read the story Spotlight CapsoVision Clears FDA for AI-Assisted Capsule Endoscopy Sep 29, 20267 min read Read the story Guidance & Policy FDA and MDIC Meet to Set Device Science Priorities Sep 28, 20265 min read Read the story Spotlight Marani Health Clears FDA for M•care Fetal Monitor Sep 27, 20267 min read Read the story Spotlight Precision Neuroscience Raises $250M for BCI Sep 26, 20267 min read Read the story Guidance & Policy FDA Drafts First Guidance for Surgical Robots Sep 26, 20266 min read Read the story Spotlight Powerful Medical Wins First FDA Nod for AI-ECG Tool Sep 23, 20266 min read Read the story Devices & Diagnostics MHRA Curbs Wireless Fetal Monitor Signal Mix-Ups Sep 22, 20265 min read Read the story Devices & Diagnostics FDA Clears Neptune Medical's Robotic Endoscope Sep 19, 20265 min read Read the story Spotlight CorTec Lands Second FDA Breakthrough Nod for BCI Sep 18, 20266 min read Read the story Guidance & Policy FDA Denies Bid to Exempt Radiology AI From 510(k) Sep 18, 20265 min read Read the story Devices & Diagnostics FDA Clears First Robotic LigaSure Vessel Sealer Sep 17, 20264 min read Read the story Devices & Diagnostics FDA Breakthrough Status for Remote Robotic Stroke Device Sep 16, 20266 min read Read the story Guidance & Policy FDA Names Permanent CDER, CBER Chiefs, New AI Post Sep 12, 20265 min read Read the story Guidance & Policy MHRA Panel Proposes 'L-Plates' for AI in Healthcare Sep 12, 20264 min read Read the story Devices & Diagnostics FDA Clears Spineart's Robotic Spine Screw App Aug 26, 20264 min read Read the story Devices & Diagnostics FDA Clears Abbott's Libre Duo Glucose-Ketone Monitor Aug 25, 20265 min read Read the story Devices & Diagnostics FDA Clears Tempus's AI Tool for Pulmonary Hypertension Aug 25, 20264 min read Read the story Devices & Diagnostics FDA Authorizes First Robotic Blood-Draw Device Aug 20, 20266 min read Read the story Guidance & Policy FDA Weighs a Competency Test for AI Medical Devices Aug 19, 20265 min read Read the story Devices & Diagnostics FDA Lets Proscia Add Scanners Without New 510(k)s Aug 6, 20265 min read Read the story Guidance & Policy MHRA Draws the Line on AI Scribes as Medical Devices Jul 29, 20265 min read Read the story Devices & Diagnostics FDA Picks Dexcom as First TEMPO Pilot Participant Jul 24, 20266 min read Read the story