Digital Health
Software, AI, apps, remote monitoring and the data behind them.
FDA Clears Deep Reasoning AI's NeuroDR Software for Neurovascular CT Angiography
The automated tool strips bone and veins from head and neck CTA scans and sends 3D artery views to hospital image archives.
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HHS Finalizes HTI-5, Cutting EHR Certification Criteria and AI Transparency Rules
The final rule removes 14 of 60 criteria, fewer than proposed, keeps privacy and security requirements and defers information blocking changes.
Eko Health Launches CORE 300 Stethoscope With AI Murmur Detection
The FDA-cleared device pairs acoustic and digital listening in one chestpiece and connects to Eko's murmur-detection software through a paid subscription.
AMA, AHA and Stanford Researchers Press FDA on Generative AI Device Oversight
Comments filed as the agency's docket on its August discussion paper closed call for real-world testing, clearer risk tiers and stronger postmarket monitoring.
SimBioSys Gets FDA Clearance for TumorSight Risk Breast Cancer Recurrence Software
The AI tool scores five- and 10-year recurrence risk from routine MRI, pathology and clinical data for a common hormone receptor-positive subtype.
JAMA Network Announces New Journal, JAMA AI, to Launch in Early 2027
The online-only title, edited by Roy Perlis, will pair AI-driven assessment with human peer review and cover apps, wearables and imaging as well as AI.
FDA Clears Click Therapeutics' Motivista App for Negative Symptoms of Schizophrenia
The prescription smartphone program, cleared through the 510(k) pathway in July and announced in October, is meant to be used alongside antipsychotic care.
AIRS Medical Gets FDA Clearance for SwiftSight Body Composition MRI Software
The AI software measures fat, muscle and liver fat from a scan the company says takes under five minutes, and SimonMed Imaging will be first to deploy it.
FDA Picks First Five Home Devices for READI-Home Readmissions Challenge
An AI monitoring tool for CAR-T patients, a wearable EEG system and a heart-function patch are among the first technologies to get early FDA engagement aimed at keeping patients out of the hospital.
FDA Clears Tempus ECG-MR AI for Signs of Undiagnosed Mitral Regurgitation
The software reads routine 12-lead ECGs from at-risk patients 65 and older and gives a yes-or-no flag that may prompt an echocardiogram; it is Tempus's fourth cleared ECG-AI product.
Study Says Machine Learning Could Help FDA Target Riskier 510(k) Submissions
Researchers modeled a human-plus-algorithm review policy on more than 31,000 submissions and estimated a 40.5% cut in reviewer workload alongside fewer later recalls.
FDA Clears a2z Radiology AI Triage Software for 10 More Abdominal CT Findings
The a2z-Abdo-Triage clearance adds appendicitis, organ trauma and ureteral stones to the Boston startup's CT worklist-flagging software, ten months after its first clearance.
FDA Clears DeepHealth Chest X-Ray AI Software Built on a Foundation Model
The computer-aided detection software flags and localizes nodules, consolidation, mediastinal abnormalities and pneumothorax, and its clearance includes a change control plan.
FDA Order Keeps 510(k) Review for Radiology AI Detection and Triage Software
A Federal Register order makes final the agency's refusal to let companies with an existing clearance add new radiology AI tools without a fresh premarket submission.
ARPA-H Names Six Teams to Build FDA-Authorized AI Agents for Heart Failure Care
The $62.7 million ADVOCATE program requires its patient-facing AI developers to submit an FDA authorization package within 24 months of award.
FDA Grants De Novo to Powerful Medical's Queen of Hearts AI Model for Heart Attack ECGs
The FDA database lists a September 3 decision for the software, which reads electrocardiograms for signs of acute coronary syndrome and comes with an authorized change control plan.
AMA Names DiMe Founder Jennifer Goldsack to Lead Center for Digital Health and AI
Goldsack, who founded and ran the Digital Medicine Society, becomes senior vice president and the first leader of the physician group's year-old digital health and AI center.
Stryker Says First Hip Surgery Done With De Novo-Authorized Apple Vision Pro App
SportSuite Vision, granted De Novo authorization on July 17, puts arthroscopic video, CT images and hip planning software into the surgeon's view through the headset; the first case was at Duke Health.
FDA Clears Tempus ECG-PH AI Software for Signs of Pulmonary Hypertension
The software reads standard 12-lead ECGs from symptomatic adults 40 and older with no known pulmonary hypertension and returns a yes-or-no flag; it is the company's third cleared cardiovascular device.
FDA Adds Limbic AI Voice Therapy and SonderMind App to TEMPO Pilot
The two behavioral health devices join Dexcom and Cadence in the pilot, which lets selected makers offer not-yet-authorized digital tools to Medicare ACCESS model participants while collecting real-world data.
Study Finds 3 of 1,357 FDA-Cleared AI Devices Were Tested on Patient Outcomes
A PLOS Digital Health analysis found that only 34 of the devices were linked to registered prospective trials, and its authors call for pre-registered trials before clearance of Class II and III AI devices.
FDA Floats Competency-Based Testing for Generative AI Medical Devices
A discussion paper from the agency's Digital Health Center of Excellence asks for comments by October 19 on risk assessment, premarket evaluation and postmarket monitoring of GenAI-enabled devices.
FDA Clears Samsung Software That Turns Galaxy Buds Into Over-the-Counter Hearing Aids
Samsung pairs the cleared Hearing Aid feature with a five-minute in-ear Hearing Test and plans a US rollout on two Galaxy Buds models in the fourth quarter of 2026.
FDA Clears Leica Biosystems AI Software That Flags Flaws in Digital Pathology Slides
Aperio iQC DX checks whole slide images for six kinds of preparation and scanning artifacts while slides are still on the scanner; a separate clearance adds a mid-volume Aperio GT 180 DX scanner.
GAO Assesses Wearables in Clinical Decision-Making, Offers Three Policy Options
The congressional watchdog's technology assessment says wearable data could speed diagnoses and extend remote monitoring, but devices vary in accuracy and are hard to fit into clinical workflows.
Philips Adds Six Wearable and Hospital-at-Home Partners to Its Patient Monitoring Ecosystem
Data from wearable patches and biosensors made by Blue Spark, Caretaker Medical, LifeSignals, Respiree and smartQare, plus Cuviva's hospital-at-home platform, will connect to Philips monitoring systems.
FDA Clears VoxNeuro's cfNI Software for EEG-Based Cognitive Assessment
The Toronto company's prescription software scores brain responses recorded during five standard tasks against a reference database, and the FDA summary says it does not provide a diagnosis.
FDA Clears Natural Cycles' Hybrid Machine Learning Fertility Algorithm
The company's sixth U.S. clearance swaps the birth control app's statistical engine for one that adds a locked machine learning model, validated on more than a million recorded cycles.
FDA Names Dexcom First Participant in TEMPO Digital Health Pilot
Dexcom's AI-based Glucose Health Program will be offered for care under Medicare's ACCESS Model while the FDA continues to evaluate it and the company reports real-world data.
Medtronic Unveils Touch Surgery Aide, a Real-Time AI Computing Platform for Its Hugo Robot
The platform's first application, FDA-cleared software that flags when robotic instruments leave the camera's view, will be shown at the Society of Robotic Surgery meeting.
FDA Clears HoneyNaps' SOMNUM V3.0 Sleep Study Software With Apnea Subtype Scoring
The 510(k) clearance updates the Korean company's polysomnography software, which now labels apnea events as obstructive, central or mixed for physician review.
FDA Grants De Novo to Autonomous Healthcare's Syncron-E Ventilator Waveform Software
The decision creates a new Class II device type, ventilator waveform analysis software, for tools that review recorded breathing data from patients on mechanical ventilation.
FDA Clears iHealthScreen's iPredict-DR AI Software for Diabetic Retinopathy Screening
The 510(k) clearance pairs the software with one retinal camera, iCare's DRSplus, and rests on an 871-subject pivotal study summarized by the FDA.
Welldoc Goes Live in CMS ACCESS Model as a Medicare Part B Supplier
The digital health company says its app is now available to eligible Original Medicare beneficiaries through the Medicare App Library, three days after the outcome-based payment model began.