FDA: Page 5

FDA moves to reclassify CAD software to class II
By Wayne Forrest
Developers of image analysis software such as computer-aided detection (CAD) algorithms may soon have an easier regulatory path to market thanks to changes announced on Friday by the U.S. Food and Drug Administration (FDA), which wants to move the products from the more-stringent class III category to class II.
May 31, 2018
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FDA hits RadLogics with warning letter
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) sent a warning letter to data analysis software developer RadLogics for claims the company has made for its AlphaPoint software.
May 13, 2018
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InSightec submits PMA to Japan for Exablate device
By AuntMinnie.com staff writers
MR-guided focused ultrasound developer InSightec has submitted a premarket approval (PMA) application to the Japanese Pharmaceuticals and Medical Devices Agency for its Exablate Neuro (Exablate 4000) device.
May 13, 2018
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: 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
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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
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