FDA

mlHealth 360 secures FDA 510(k) for ICH triage tool
By AuntMinnie.com staff writers
mlHealth 360 has received U.S. Food and Drug Administration (FDA) clearance for its Scaida BrainCT-ICH AI-powered triage software.
December 5, 2025
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RapidAI gets FDA clearance for Rapid Aortic
By AuntMinnie.com staff writers
Rapid AI has received U.S. Food and Drug Administration (FDA) clearance for Aortic Management, part of its Rapid Aortic application.
November 18, 2025
Futuristic 3 D Heart Screen
HeartFlow secures 510(k) for next-gen algorithm
By AuntMinnie.com staff writers
Corresponding with the FDA clearance, the company also highlighted the unveiling of its DECIDE Registry.
September 23, 2025
Heart Glowing Red
Telix, FDA agree on NDA resubmission path for Pixclara
By AuntMinnie.com staff writers
Telix has reached an agreement with the U.S. FDA on a resubmission plan for its New Drug Application (NDA) for Pixclara.
September 9, 2025
Glioma Letters Brain
U.S. FDA clears 4DMedical's ventilation-perfusion CT:VQ imaging system
By AuntMinnie.com staff writers
CT:VQ converts standard, noncontrast chest CTs into quantitative, lobar ventilation, and perfusion maps.
September 5, 2025
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FDA rejects Telix's BLA for kidney cancer investigational PET agent
By AuntMinnie.com staff writers
The U.S. FDA has requested additional data from Telix for its biologics license application (BLA) regarding its TLX250-CDx PET agent.
August 29, 2025
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Radiology drives July FDA AI-enabled medical device update
By Liz Carey
The U.S. FDA has just publicly listed 211 AI-enabled medical devices that have received regulatory clearances
July 14, 2025
Fda Sign Dc 400 (1)
FDA approves updated label for Lilly's Kisunla
By AuntMinnie.com staff writers
The label update is expected to reduce the incidence of ARIA-E.
July 9, 2025
Ad Mri
FDA clears Insightec's ultrasound treatment for Parkinson’s
By AuntMinnie.com staff writers
The U.S. FDA has cleared Insightec's focused ultrasound treatment for patients with advanced Parkinson's disease.
July 8, 2025
Fda Sign Dc
FDA cites MRI study in new requirements for COVID-19 manufacturers
By Amerigo Allegretto
Cardiac MRI exams played a part in the U.S. FDA's requirements recently issued on COVID-19 vaccines and heart inflammation.
June 26, 2025
Covid 19 Vaccine Administer 400
FDA approves expanded uses for GE Healthcare’s Vizamyl
By AuntMinnie.com staff writers
The U.S. FDA has approved expanded indications for GE HealthCare’s Vizamyl PET imaging agent for beta-amyloid detection.
June 24, 2025
Brain Amyloid Plaque Neuron
FDA issues final order reclassifying radiological CAD software
By Liz Carey
Computer-assisted detection (CAD) and diagnosis algorithms used in radiology move from the class III to the class II category.
June 13, 2025
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