AI-enabled medical device updates
New FDA authorizations from the AI-Enabled Medical Devices list, the FDA list of authorized devices with predetermined change control plans (PCCPs), and radiology AI news from RadAISlice, each linking to the full original record or article.
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This feed refreshes automatically every 24 hours from the FDA AI-Enabled Medical Devices list and RadAISlice.
What is a PCCP?
A predetermined change control plan describes the modifications a manufacturer plans to make to a device, how each change will be developed and validated, and how its impact will be assessed. Once FDA authorizes the plan, those changes can be implemented without a new marketing submission. Search by device, company, panel, product code or submission number (for example K261517).
- Radiology AIFDA Approves SimBioSys AI Tool for Breast Cancer Risk via MRI
SimBioSys received FDA clearance for TumorSight Risk, an AI tool assessing breast cancer recurrence risk using MRI.
- Radiology AILLMs Rarely Recommend Unnecessary Imaging, Except for Thyroid Ultrasound
Large language models seldom over-recommend imaging, but thyroid ultrasound guidance shows substantial discrepancies.
- Radiology AIPenn Medicine's Percival AI Detects Hidden Health Risks in CT Scans
Penn Medicine's Percival AI leverages CT scans to uncover unseen health risks and disease patterns, expanding the utility of radiological imaging.
- Radiology AISNU Team Develops Omnimodal AI Model for Robotic Task Control, Eyes Medical Use
SNU engineers unveiled a unified AI model, Dynin-Robotics, that interprets language, predicts outcomes, and executes real-world robotic tasks with pot
- PCCPPCCP authorized: TEMPUS ECG-MR (TEMPUS AI, INC.)
K254297 · CARDIOVASCULAR panel · Product code SBQ (AI-ECG risk assessment software). Authorized with a Predetermined Change Control Plan.
Updates are collected automatically from the FDA and RadAISlice and link back to the original announcement. Cahir MedTech does not alter source wording.
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