Regulatory: Page 52

Mevion submits 510(k) to FDA for proton therapy system
By AuntMinnie.com staff writers
Mevion Medical Systems has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for the Mevion S250i proton therapy system with the company's Hyperscan pencil-beam scanning technology.
September 17, 2017
Republican senators introduce healthcare reform bill
By AuntMinnie.com staff writers
Four U.S. senators have introduced legislation to repeal and replace the Patient Protection and Affordable Care Act.
September 12, 2017
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Help wanted: FDA seeks hires for digital health team
By AuntMinnie.com staff writers
Are you a digital health expert or entrepreneur? The U.S. Food and Drug Administration (FDA) may have a job for you with its Center for Devices and Radiological Health digital health team.
September 11, 2017
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Guerbet issues statement on FDA gadolinium vote
By AuntMinnie.com staff writers
Contrast agent manufacturer Guerbet has issued a statement regarding gadolinium retention from MRI contrast media following today's meeting of the U.S. Food and Drug Administration's (FDA) Medical Imaging Drugs Advisory Committee.
September 7, 2017
FDA panel votes to add retention warning to GBCA labels
By Wayne Forrest
The U.S. Food and Drug Administration's (FDA) Medical Imaging Drugs Advisory Committee voted overwhelmingly on Friday to recommend that the agency revise prescribing information for MRI gadolinium-based contrast agents (GBCAs) to include a warning about gadolinium retention in certain organs and tissue.
September 7, 2017
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FDA panel to tackle questions on gadolinium retention
By Wayne Forrest
The baffling issue of gadolinium retention in patients receiving gadolinium-based contrast agents for MRI scans will be front and center before a committee meeting of the U.S. Food and Drug Administration (FDA) on Friday, September 8, in Silver Spring, MD.
September 6, 2017
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Delphinus launches SoftVue clinical study
By AuntMinnie.com staff writers
Tomographic ultrasound technology developer Delphinus Medical Technologies announced that the first patient has been enrolled in a clinical study that will compare the performance of its SoftVue breast ultrasound device with mammography in dense breast tissue.
September 5, 2017
iCAD scores Chinese OK for balloon applicators
By AuntMinnie.com staff writers
iCAD has received approval from the China Food and Drug Administration for the company's Xoft Axxent balloon applicators for the treatment of early-stage breast cancer.
August 30, 2017
FDA releases 6-month pilot EQUIP results
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration's (FDA) Division of Mammography Quality Standards has released a six-month analysis of inspections performed under the pilot year of the Enhancing Quality Using the Inspection Program (EQUIP) initiative.
August 29, 2017
FDA issues medical device guidance
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has issued new guidance on the use of real-world evidence in medical device development.
August 29, 2017
USPSTF to take another look at AAA screening
By Erik L. Ridley
Will the U.S. Preventive Services Task Force (USPSTF) change its recommendations for abdominal aortic aneurysm (AAA) screening? It's too early to tell, but the task force published a draft research plan on August 10 to share its vision for how it will reassess the benefits and harms of ultrasound screening.
August 10, 2017
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FDA, RSNA plan joint 3D printing workshop
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration's (FDA) Centers for Devices and Radiological Health and the RSNA's 3D printing Special Interest Group will be holding a joint meeting on August 31 at the FDA's White Oak Campus in Silver Spring, MD.
August 7, 2017
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