FDA accepts Lumicell breast cancer optical imaging agent NDA
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
Lumicell submits application to FDA
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
Seno secures supplemental PMA for Imagio
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
ViewRay submits 510(k) for updated version of MRIdian
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
FDA launches online 510(k) submission tracker
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
Nanox files 510(k) for multisource tomo x-ray
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
BWXT to manufacture Boston Scientific's TheraSphere glass microspheres
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
FDA gives 510(k) clearance ControlRad Select
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
Seno gets FDA nod for breast optoacoustic ultrasound
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
FDA proposal to relax 510(k) rules on AI raises eyebrows
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
Axonics files PMA supplement for further MRI labeling
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
Japan to pay for Insightec MRgFUS for Parkinson's
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
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