FDA: Page 4

FDA moves to electronic-only device submissions
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) now requires medical device premarket submissions to be sent electronically, eliminating the need for multiple paper submissions.
December 12, 2019
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FDA proposes change in MRI coil 510(k) submissions
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has proposed a revision to performance and safety information in 510(k) submissions for certain MRI coils.
December 5, 2019
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FDA offers guidance on coated devices
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has issued a guidance document on what labeling and other information should be included when submitting premarket applications (PMAs) and 510(k) clearance applications for coated implantable medical devices.
October 9, 2019
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FDA releases final guidance for special 510(k) process
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has released a final guidance on its Special 510(k) program.
September 11, 2019
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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
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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
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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
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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
2018 11 09 17 35 8655 Elekta Astro 400
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