Regulatory: Page 2

FDA clears GE HealthCare's deep learning-based image processing software
The U.S. Food and Drug Administration (FDA) has cleared GE HealthCare's Precision DL deep learning-based image processing software.
May 29, 2023
2021 11 30 16 39 4000 Ge Rsna 2021 400
FDA accepts Lumicell breast cancer optical imaging agent NDA
The U.S. Food and Drug Administration (FDA) has accepted for review Lumicell's new drug application for its Lumisight optical imaging agent for breast cancer and a premarket approval application for the company's direct visualization system.
May 21, 2023
2021 04 29 18 14 4885 Breast Cancer 3 D 400
Neurophet receives FDA clearance for Aqua
Artificial intelligence software developer Neurophet has secured U.S. Food and Drug Administration (FDA) 510(k) clearance for its Aqua brain MRI analysis software.
May 17, 2023
2023 03 30 20 37 0565 Mri Brain Disease4 400
Lumicell submits application to FDA
Lumicell has submitted a premarket approval application to the U.S. Food and Drug Administration (FDA) for the company's investigational direct visualization system.
April 19, 2023
2016 10 05 17 45 45 493 Breast Cancer 400
Advantis gets FDA clearance for MRI analysis software
Imaging software developer Advantis Medical Imaging has garnered U.S. Food and Drug Administration (FDA) clearance for its Advantis Platform brain and prostate MRI analysis software.
April 13, 2023
2020 02 24 17 44 7728 Clearance Stamp 400
Imaging leaders sound off on legal challenge to free preventive services
A federal court ruling that vacated nationwide insurance mandates for free preventive services such as cancer screenings will have "major ramifications" for people seeking these services as well as for public health overall, according to imaging leaders and legal experts.
April 12, 2023
2020 03 04 22 35 5609 Patient Woman Stressed 400
Annalise.ai gets FDA nod for additional AI CT, x-ray indications
Artificial intelligence (AI) software developer Annalise.ai has secured clearances from the U.S. Food and Drug Administration (FDA) that cover additional indications for use of its CT and x-ray triage and notification software.
April 11, 2023
2021 08 09 21 54 9079 Doctor Woman Ct Scan Lung 400
FDA issues draft guidance for recommendations on AI devices
The U.S. Food and Drug Administration (FDA) has issued draft guidance asking for comments on regulatory approaches for medical devices enabled by artificial intelligence (AI) and machine learning.
April 5, 2023
2019 02 13 19 24 5396 Fda Logo V2 400
ASRT names advocacy award winners
The American Society of Radiologic Technologists (ASRT) recently named James Reaves of Georgia and the New York State Society of Radiologic Sciences as the respective winners of the 2023 ASRT individual and affiliate Awards for Advocacy.
April 5, 2023
2020 02 03 22 07 3929 Trophy Award 400
Bot Image's prostate MRI AI software wins new clearance
MRI software developer Bot Image has secured an expanded clearance from the U.S. Food and Drug Administration clearance for its ProstatID AI software.
March 27, 2023
2019 04 17 20 48 2514 Prostate 3 D 400
Viz.ai nets FDA nod for AAA detection algorithm
Artificial intelligence (AI) software developer Viz.ai has garnered U.S. Food and Drug Administration (FDA) clearance for its abdominal aortic aneurysm (AAA) detection algorithm.
March 20, 2023
2020 04 08 22 56 1794 Artificial Intelligence Face 400
Brainomix secures FDA clearance for stroke AI software
Artificial intelligence (AI) software developer Brainomix has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its flagship e-ASPECTS stroke imaging software.
March 20, 2023
2020 02 24 17 44 7728 Clearance Stamp 400
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