FDA: Page 5

FDA proposes new path to 510(k) clearance
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has proposed a new pathway for vendors to receive 510(k) clearance for certain moderate-risk devices.
April 10, 2018
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Hologic wins FDA approval for new DBT technologies
By AuntMinnie.com staff writers
Women's imaging firm Hologic said the U.S. Food and Drug Administration (FDA) has approved its premarket approval application for the Clarity HD and Intelligent 2D digital breast tomosynthesis (DBT) technologies.
March 26, 2018
FDA clears Viz.ai's stroke detection software
By Erik L. Ridley
In a move that blazes a regulatory trail for developers of imaging artificial intelligence (AI) software, the U.S. Food and Drug Administration (FDA) has given its blessing to Viz.ai for Contact, an AI-based application that analyzes CT images and notifies providers that a patient might be having a stroke.
February 12, 2018
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FDA updates policy for nixing 510(k) submissions
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has issued new guidelines on its policy for determining when it will refuse to accept submissions for new 510(k) applications for medical devices.
January 30, 2018
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C-MIMI show explores AI and radiology | PET shows revival of comatose patient | Best Radiology Image voting
By Brian Casey
September 27, 2017
C-MIMI: FDA decision paves the way for imaging AI
By Erik L. Ridley
BALTIMORE - A recent U.S. Food and Drug Administration (FDA) ruling will make it easier to commercialize artificial intelligence (AI) software for medical imaging applications, an FDA representative said at the Society for Imaging Informatics in Medicine's Conference on Machine Intelligence in Medical Imaging (C-MIMI).
September 27, 2017
2017 09 26 22 22 8756 Baltimore Harbor 400
Mevion submits 510(k) to FDA for proton therapy system
By AuntMinnie.com staff writers
Mevion Medical Systems has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for the Mevion S250i proton therapy system with the company's Hyperscan pencil-beam scanning technology.
September 17, 2017
Delphinus launches SoftVue clinical study
By AuntMinnie.com staff writers
Tomographic ultrasound technology developer Delphinus Medical Technologies announced that the first patient has been enrolled in a clinical study that will compare the performance of its SoftVue breast ultrasound device with mammography in dense breast tissue.
September 5, 2017
FDA responds to IsoRay's GammaTile 510(k)
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has issued a response to medical isotope developer IsoRay's pending 510(k) application for its GammaTile radiation therapy system.
July 5, 2017
Hologic nets FDA OK for tomo claim in dense breasts
By AuntMinnie.com staff writers
Women's imaging vendor Hologic has received approval from the U.S. Food and Drug Administration (FDA) to claim that its Genius 3D mammography tomosynthesis exam is superior for women with dense breasts.
June 6, 2017
SIIM: AI poised to enhance all aspects of radiology
By Erik L. Ridley
PITTSBURGH - Artificial intelligence (AI) will persistently and pervasively enhance all aspects of radiology, enabling precision medicine and potentially even finding disease before it becomes symptomatic, said Dr. Keith Dreyer, PhD, on Thursday at the Society for Imaging Informatics in Medicine (SIIM) annual meeting.
May 31, 2017
2017 06 01 10 11 07 128 Pittsburgh 400
NucleusHealth scores 510(k) for Nucleus.io software
By AuntMinnie.com staff writers
NucleusHealth has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Nucleus.io cloud software for secure medical image management.
May 25, 2017
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