Regulatory: Page 3

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
FDA approves new drug for Alzheimer's disease
By Will Morton
Japanese drug developer Eisai has received U.S. Food and Drug Administration (FDA) approval for its Leqembi (lecanemab) treatment for individuals with Alzheimer's disease. The drug is the second of a new category of medications for the disease to go through the FDA's accelerated regulatory pathway.
January 5, 2023
2022 01 12 18 18 1479 Patient Elderly Confused Headache 400
Radiology Patient Action Network praises Congress's Medicare support
By AuntMinnie.com staff writers
The Radiology Patient Action Network, part of the Radiology Business Management Association (RBMA), is urging long-term fixes for Medicare payments but also praising "limited" congressional support.
December 21, 2022
2019 07 31 17 01 7432 Medicare Puzzle 400
FDA issues notice on MRI supply delays, shortages
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) is recommending that healthcare providers discuss alternative options for MRI-guided breast biopsy procedures with patients due to supply chain disruptions.
October 31, 2022
2016 09 02 09 36 05 93 Fda Logo V2 400
Do AI validation studies leave out key information?
By Amerigo Allegretto
Despite an increase in regulatory approvals, not many artificial intelligence (AI) algorithms for medical imaging cleared by the U.S. Food and Drug Administration (FDA) reveal key information used in clinical studies, researchers have found.
October 30, 2022
2021 02 25 18 39 1229 Computer Artificial Intelligence Question 400
ITM-11 gets fast-track nod from FDA
By AuntMinnie.com staff writers
ITM Isotope Technologies Munich SE's ITM-11 was recently granted fast-track designation by the U.S. Food and Drug Administration (FDA).
October 26, 2022
2018 12 11 00 02 7009 Atom Nuclear Lab 400
Intelligent Ultrasound nerve block device gets FDA clearance
By AuntMinnie.com staff writers
Intelligent Ultrasound Group said its ScanNav Anatomy Peripheral Nerve Block device has been granted de novo clearance for clinical use by the U.S. Food and Drug Administration (FDA).
October 19, 2022
2020 08 12 16 08 9001 Ultrasound Sound Waves 400
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