Regulatory: Page 17

Study suggests No Surprises Act simply veils insurance coverage gaps
By AuntMinnie.com staff writers
The No Surprises Act, slated to go into effect January 1, 2022, was enacted to protect patients from surprise medical billing. But it could result in insurers gaining leverage over physician practices in out-of-network reimbursement disputes, according to a study published July 6 in Radiology.
July 7, 2021
2020 07 01 22 14 2802 Washington Dc Capitol 400
RaySearch brings RayStation 9 to China
By AuntMinnie.com staff writers
Radiation therapy software developer RaySearch Laboratories has received regulatory clearance in China for its RayStation 9 software.
July 5, 2021
2019 09 17 16 52 3040 Raysearch Astro 2019
Interventional Systems gets FDA nod for medical robot
By AuntMinnie.com staff writers
Austrian firm Interventional Systems has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Micromate medical robot.
June 28, 2021
2020 02 24 17 44 7728 Clearance Stamp 400
Nanox files 510(k) for multisource tomo x-ray
By AuntMinnie.com staff writers
X-ray developer Nanox said it has applied for 510(k) clearance with the U.S. Food and Drug Administration (FDA) for the first version of the company's multisource 3D digital tomosynthesis x-ray system.
June 16, 2021
2021 04 02 17 34 8177 2021 04 02 Nanox Beauty Shot 20210402171431
Kheiron brings Mia to Australia, New Zealand
By AuntMinnie.com staff writers
Artificial intelligence software developer Kheiron Medical Technologies has received clearance for its Mia mammography breast cancer screening software in Australia and New Zealand.
June 14, 2021
2020 02 24 17 44 7728 Clearance Stamp 400
Varian nets FDA breakthrough nod for radioablation unit
By AuntMinnie.com staff writers
Radiation oncology vendor Varian Medical Systems has garnered a breakthrough device designation from the U.S. Food and Drug Administration (FDA) for its cardiac radioablation system.
May 27, 2021
2020 01 30 01 49 9107 Varian Astro 2019 400
FDA issues mammography alert for Md. facility
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) said it's alerting patients who had mammograms at Laurel Radiology Services in Laurel, MD, on or after June 26, 2018, about possible problems with the quality of their mammograms.
May 20, 2021
2016 09 02 09 36 05 93 Fda Logo V2 400
FDA releases final guidance on medical device safety for MRI
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has released final guidance on how facilities should assess the safety and compatibility of medical devices in the MRI suite and recommended format for MRI safety information in medical device labeling.
May 18, 2021
2016 09 02 09 36 05 93 Fda Logo V2 400
CMS opens review of expanded CT lung screening reimbursement
By Brian Casey
CT lung cancer screening could see expanded Medicare reimbursement soon. The U.S. Centers for Medicare and Medicaid Services (CMS) on May 18 opened up a review of its reimbursement policies in response to recent changes expanding the number of individuals who are eligible to be screened.
May 17, 2021
2020 12 03 23 01 2984 Cigarette Smoker Closeup 400
Ultrasound societies say 'no change' to contrast agent policy
By Amerigo Allegretto
No changes should be made to clinical guidelines on the use of ultrasound contrast agents in the wake of the U.S. Food and Drug Administration's recent statement on adverse reactions to contrast, according to statements made by a group of medical societies.
May 10, 2021
2020 08 12 16 08 9001 Ultrasound Sound Waves 400
Whiterabbit gets FDA nod for breast density AI software
By AuntMinnie.com staff writers
Women's imaging artificial intelligence (AI) startup Whiterabbit has garnered U.S. Food and Drug Administration (FDA) clearance for its WRDensity breast density analysis software.
May 10, 2021
2019 12 09 17 23 6730 Artificial Intelligence Ai Suit 400
BWXT to manufacture Boston Scientific's TheraSphere glass microspheres
By AuntMinnie.com staff writers
Medical isotope and radiopharmaceutical supplier BWXT Medical has signed an agreement with Boston Scientific to manufacture that firm's TheraSphere yttrium-90 glass microspheres.
May 9, 2021
2018 04 24 20 24 4264 Isotope 400
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