FDA: Page 3

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
2019 02 13 19 24 5396 Fda Logo V2 400
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
2021 04 02 17 34 8177 2021 04 02 Nanox Beauty Shot 20210402171431
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
2018 04 24 20 24 4264 Isotope 400
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
2016 10 18 11 34 57 70 Check Mark 400
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
2019 11 14 18 07 2163 Computer Doctor Future 400
Axonics files PMA supplement for further MRI labeling
By AuntMinnie.com staff writers
Axonics Modulation Technologies has filed a premarket approval (PMA) supplement with the U.S. Food and Drug Administration to secure clearance for detachable extremity coil MRI conditional labeling for its implantable sacral neuromodulation device on 1.5-tesla and 3-tesla scanners.
October 28, 2020
2019 02 13 19 24 5396 Fda Logo V2 400
Japan to pay for Insightec MRgFUS for Parkinson's
By AuntMinnie.com staff writers
MR-guided focused ultrasound (MRgFUS) developer Insightec said that the Japanese Ministry of Health, Labor, and Welfare will provide reimbursement for the use of its Exablate Neuro device in treating Parkinson's disease.
September 1, 2020
2020 09 02 18 40 1978 Parkinsons Definition 400
CDRH now taking radiation safety reports by email
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH) is now accepting radiation safety reports by email.
June 10, 2020
2019 02 13 19 24 5396 Fda Logo V2 400
Axionics submits PMA for 3-tesla MRI labeling
By AuntMinnie.com staff writers
Axonics Modulation Technologies has submitted a premarket approval application (PMA) to the U.S. Food and Drug Administration to gain full-body 3-tesla MRI labeling for its implantable sacral neuromodulation devices used to treat urinary and bowel dysfunction.
April 5, 2020
2019 10 30 21 07 4735 Mri Scanner Control Room 400
FDA proposes electronic 510(k) submission template
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) is considering a new optional electronic 510(k) submission template designed to better organize information in submissions for scientific review.
February 25, 2020
2019 02 13 19 24 5396 Fda Logo V2 400
Elekta gets FDA nod for DWI-MR radiation therapy
By AuntMinnie.com staff writers
Radiation oncology vendor Elekta has received 510(k) premarket notification from the U.S. Food and Drug Administration (FDA) for the clinical use of a diffusion-weighted imaging (DWI) MRI protocol with the company's Unity MR radiation therapy system.
December 15, 2019
2019 09 17 17 08 4562 Elekta Astro 2019
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