FDA

DESKi granted FDA clearance for cardiac AI software
By AuntMinnie.com staff writers
The U.S. FDA has granted 510(k) clearance to DESKi for its HeartFocus AI-enabled cardiac exam software.
April 15, 2025
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Brainomix stroke software granted FDA clearance
By AuntMinnie.com staff writers
The U.S. FDA has granted 510(k) clearance to Brainomix for a feature of its 360 Stroke software.
April 8, 2025
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FDA greenlights Telix NDA for prostate imaging agent Gozellix
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has approved a new drug application (NDA) for Telix's TLX007-CDx for prostate cancer imaging.
March 21, 2025
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Xeris secures FDA approval for Gvoke VialDx for x-ray exams
By AuntMinnie.com staff writers
Biopharma firm Xeris has received FDA approval for its Gvoke VialDx to be used as a diagnostic aid for abdominal x-ray exams.
March 18, 2025
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GE HealthCare secures 510(k) for updated Voluson Expert ultrasound
By AuntMinnie.com staff writers
Enhancements support AI in women's imaging, particularly in complex, high-risk pregnancies.
January 28, 2025
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FDA issues guidance on scanning interference with implanted medical devices
By AuntMinnie.com staff writers
The FDA has received some reports of electronic medical devices being damaged during CT scans.
October 25, 2024
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FDA accepts Lumicell breast cancer optical imaging agent NDA
By AuntMinnie.com staff writers
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
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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
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Seno secures supplemental PMA for Imagio
By AuntMinnie.com staff writers
Optoacoustic imaging firm Seno Medical Instruments has received supplemental premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) for its Imagio breast imaging system.
June 27, 2022
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ViewRay submits 510(k) for updated version of MRIdian
By AuntMinnie.com staff writers
Image-guided radiation therapy vendor ViewRay has submitted a 510(k) application for an updated version of its MRIdian MRI-guided radiation therapy system.
October 3, 2021
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FDA launches online 510(k) submission tracker
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has launched a 510(k) submission tracker to enable companies to follow their regulatory submissions to the agency.
August 29, 2021
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Nanox files 510(k) for multisource tomo x-ray
By AuntMinnie.com staff writers
X-ray developer Nanox said it has applied for 510(k) clearance with the U.S. Food and Drug Administration (FDA) for the first version of the company's multisource 3D digital tomosynthesis x-ray system.
June 16, 2021
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