FDA

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
2021 04 29 18 14 4885 Breast Cancer 3 D 400
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
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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BWXT to manufacture Boston Scientific's TheraSphere glass microspheres
By AuntMinnie.com staff writers
Medical isotope and radiopharmaceutical supplier BWXT Medical has signed an agreement with Boston Scientific to manufacture that firm's TheraSphere yttrium-90 glass microspheres.
May 9, 2021
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FDA gives 510(k) clearance ControlRad Select
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to medical device company ControlRad for the marketing of its ControlRad Select radiation dose-reduction technology.
March 2, 2021
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Seno gets FDA nod for breast optoacoustic ultrasound
By AuntMinnie.com staff writers
Optoacoustic imaging firm Seno Medical Instruments has garnered U.S. Food and Drug Administration (FDA) premarket approval for its Imagio breast imaging optoacoustic ultrasound system.
January 18, 2021
2020 05 27 21 35 5485 Breast Cancer3 400
FDA proposal to relax 510(k) rules on AI raises eyebrows
By Brian Casey
A proposal by the U.S. Food and Drug Administration (FDA) to eliminate 510(k) review for a number of artificial intelligence (AI) software applications is raising eyebrows in the radiology industry. The question is whether the proposal will be implemented after the Trump administration ends this week.
January 18, 2021
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