FDA: Page 4

FDA issues proposals to improve MRI safety
By Wayne Forrest
The U.S. Food and Drug Administration (FDA) on August 1 published a list of proposals to further ensure the safety of patients and staff in MRI environments and bolster both safety testing and MRI information in medical device labeling.
July 31, 2019
2016 09 02 09 28 19 895 Fda Logo 400
RefleXion files 510(k), opens manufacturing facility
By AuntMinnie.com staff writers
Radiation therapy equipment developer RefleXion Medical has filed a 510(k) application with the U.S. Food and Drug Administration for its biology-guided radiotherapy system. The firm also opened a new 50,000-sq-ft manufacturing facility in Hayward, CA.
May 22, 2019
2019 05 23 15 24 6544 Reflexion Hq 2019
Elekta gets Canadian clearance for Unity MR
By AuntMinnie.com staff writers
Radiation oncology vendor Elekta has received a Medical Device License from Health Canada for the sale of its Elekta Unity MR radiation therapy system in Canada.
March 24, 2019
2018 11 09 17 35 8655 Elekta Astro 400
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
2016 09 02 09 36 05 93 Fda Logo V2 400
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
2018 11 09 17 35 8655 Elekta Astro 400
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
2016 09 02 09 36 05 93 Fda Logo V2 400
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
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