FDA: Page 4

Biotronik gets FDA nod for 3T tachycardia devices
By AuntMinnie.com staff writers
Biomedical device company Biotronik has received premarket approval from the U.S. Food and Drug Administration (FDA) for its Acticor and Rivacor families of high-voltage cardiac rhythm management devices.
March 17, 2019
Axonics files with FDA for full-body MRI labeling
By AuntMinnie.com staff writers
Axonics Modulation Technologies has submitted an application to the U.S. Food and Drug Administration (FDA) to enable the company to add full-body MRI-conditional status to the regulatory labeling of its Axonics r-SNM sacral neuromodulation implants.
February 12, 2019
Centerline submits 510(k) for navigation system
By AuntMinnie.com staff writers
Centerline Biomedical has submitted a 510(k) application with the U.S. Food and Drug Administration for its Intra-Operative Positioning System (IOPS), which the company sees as a potential alternative to fluoroscopy for intraoperative navigation.
January 29, 2019
FDA posts final guidance for new 510(k) pathway
By Erik L. Ridley
The U.S. Food and Drug Administration (FDA) has published its final guidance on a new regulatory pathway that would allow manufacturers to show that their medical devices meet specific performance criteria to achieve 510(k) clearance.
January 22, 2019
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FDA clears Elekta's Unity MR radiation therapy system
By AuntMinnie.com staff writers
Radiation oncology vendor Elekta has received 510(k) premarket approval from the U.S. Food and Drug Administration (FDA) for its Elekta Unity MR radiation therapy system for sale and clinical use in the U.S.
December 5, 2018
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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
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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
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