Regulatory: Page 37

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 issues warning on PAD vascular balloon, stent
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has issued a warning to healthcare professionals about the use of certain drug-containing balloons and stents in patients with peripheral arterial disease (PAD).
January 17, 2019
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Both sides weigh in on plan to loosen radiopharma rules
By Wayne Forrest
The U.S. Nuclear Regulatory Commission's proposal to create a way for physicians with little or no background in nuclear medicine to become "limited authorized users" and dispense radiopharmaceuticals is drawing both opposition and support from across the healthcare spectrum.
January 15, 2019
2018 12 11 00 02 7009 Atom Nuclear Lab 400
FDA unveils draft framework for Pre-Cert pilot program
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has released a draft regulatory framework and other new documents that delineate the agency's vision and plans for its Software Precertification (Pre-Cert) initiative for developers of medical software, including artificial intelligence applications.
January 10, 2019
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FDA to update radiation control rules
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has issued a draft guidance for an update to its radiation control regulations covering the manufacturing of diagnostic x-ray equipment. The guidance will supersede previous rules issued in 1989.
December 19, 2018
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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
Bayer gets breakthrough nod for AI algorithm
By AuntMinnie.com staff writers
An artificial intelligence (AI) algorithm being developed by Bayer and Merck for the diagnosis of pulmonary hypertension will receive expedited review at the U.S. Food and Drug Administration after being designated as a breakthrough device.
December 2, 2018
2018 12 03 21 20 5022 Bayer Rsna 2018 400
Varian gets China OK for Halcyon system
By AuntMinnie.com staff writers
Radiation oncology firm Varian Medical Systems has received clearance for its Halcyon system by the China National Medical Product Administration.
November 27, 2018
2018 10 23 16 33 0372 Varian Astro
ScreenPoint gets FDA OK for Transpara AI mammo software
By AuntMinnie.com staff writers
Dutch women's imaging software developer ScreenPoint Medical has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Transpara artificial intelligence (AI) software for screening mammography.
November 25, 2018
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
NRC proposes new pathway for radiopharmaceutical users
By AuntMinnie.com staff writers
The U.S. Nuclear Regulatory Commission (NRC) is seeking feedback on a proposal to allow physicians to become "limited authorized users" for administering certain therapeutic and theranostic radiopharmaceuticals.
November 12, 2018
OIG finds FDA lacking in postmarket cybersecurity plans
By Erik L. Ridley
After calling on the U.S. Food and Drug Administration (FDA) in September to further integrate cybersecurity into its premarket review process, the U.S. Office of Inspector General (OIG) has now deemed the FDA's policies and processes to be "deficient" for addressing postmarket cybersecurity incidents with medical devices.
November 11, 2018
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