FDA: Page 5

FDA to finalize new 510(k) pathway
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) is finalizing plans to establish an alternative 510(k) approval pathway for medical devices it says will be transformative for the industry.
November 25, 2018
Novarad gets 510(k) for augmented reality software
By AuntMinnie.com staff writers
RIS/PACS vendor Novarad has received 510(k) clearance from the U.S. Food and Drug Administration for its OpenSight augmented reality software.
October 24, 2018
FDA proposes update to cybersecurity guidance
By Wayne Forrest
The U.S. Food and Drug Administration (FDA) has released a proposal to strengthen cybersecurity protection for medical devices, replacing guidance first issued in 2014.
October 16, 2018
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C-MIMI: FDA readies program to speed software reviews
By Kate Madden Yee
SAN FRANCISCO - The U.S. Food and Drug Administration (FDA) wants to make it easier for software developers to get regulatory clearance for their products with a new approach similar to the precertification program used for airline travelers, according to a presentation delivered at the Conference on Machine Intelligence in Medical Imaging (C-MIMI).
September 10, 2018
2017 06 05 10 24 07 864 San Francisco Golden Gate 400
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
2016 09 02 09 36 05 93 Fda Logo V2 400
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
2016 09 02 09 36 05 93 Fda Logo V2 400
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
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