FDA: Page 3

Japan to pay for Insightec MRgFUS for Parkinson's
By AuntMinnie.com staff writers
MR-guided focused ultrasound (MRgFUS) developer Insightec said that the Japanese Ministry of Health, Labor, and Welfare will provide reimbursement for the use of its Exablate Neuro device in treating Parkinson's disease.
September 1, 2020
2020 09 02 18 40 1978 Parkinsons Definition 400
CDRH now taking radiation safety reports by email
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH) is now accepting radiation safety reports by email.
June 10, 2020
2019 02 13 19 24 5396 Fda Logo V2 400
Axionics submits PMA for 3-tesla MRI labeling
By AuntMinnie.com staff writers
Axonics Modulation Technologies has submitted a premarket approval application (PMA) to the U.S. Food and Drug Administration to gain full-body 3-tesla MRI labeling for its implantable sacral neuromodulation devices used to treat urinary and bowel dysfunction.
April 5, 2020
2019 10 30 21 07 4735 Mri Scanner Control Room 400
FDA proposes electronic 510(k) submission template
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) is considering a new optional electronic 510(k) submission template designed to better organize information in submissions for scientific review.
February 25, 2020
2019 02 13 19 24 5396 Fda Logo V2 400
Elekta gets FDA nod for DWI-MR radiation therapy
By AuntMinnie.com staff writers
Radiation oncology vendor Elekta has received 510(k) premarket notification from the U.S. Food and Drug Administration (FDA) for the clinical use of a diffusion-weighted imaging (DWI) MRI protocol with the company's Unity MR radiation therapy system.
December 15, 2019
2019 09 17 17 08 4562 Elekta Astro 2019
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
2016 09 02 09 36 05 93 Fda Logo V2 400
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
2016 09 02 09 28 19 895 Fda Logo 400
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
2016 09 02 09 36 05 93 Fda Logo V2 400
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
2016 09 02 09 36 05 93 Fda Logo V2 400
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
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