Regulatory: Page 5

Lumicell submits application to FDA
By AuntMinnie.com staff writers
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
By AuntMinnie.com staff writers
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
By Amerigo Allegretto
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
By AuntMinnie.com staff writers
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FDA issues draft guidance for recommendations on AI devices
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has issued draft guidance asking for comments on regulatory approaches for medical devices enabled by artificial intelligence (AI) and machine learning.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
By AuntMinnie.com staff writers
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
By AuntMinnie.com staff writers
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
By AuntMinnie.com staff writers
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
By AuntMinnie.com staff writers
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
GE HealthCare recalls certain nuclear medicine systems
By Amerigo Allegretto
GE HealthCare is recalling its 600 and 800 Series nuclear medicine systems after identifying an issue with two safety mechanisms that could potentially lead to a "catastrophic fall" of a detector and potentially trap or crush patients.
February 15, 2023
2021 11 30 16 39 4000 Ge Rsna 2021 400
Varian secures FDA clearance for Halcyon, Ethos radiotherapy systems
By AuntMinnie.com staff writers
Varian, a Siemens Healthineers company, has secured 510(k) clearance from the U.S. Food and Drug Administration (FDA), as well as the CE mark, for its Halcyon and Ethos radiotherapy systems featuring its HyperSight technology.
February 1, 2023
2019 08 29 18 18 5039 Quality Check Mark 400
Week in review: California radiologist arrested | Breast MRI downgrades BI-RADS 3 lesions | The promise of FAPI-PET
By Erik L. Ridley
January 6, 2023
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