Regulatory: Page 14

FDA signs off on change to contraindications for GE's Optison agent

By AuntMinnie.com staff writers

The U.S. Food and Drug Administration (FDA) has approved the removal of hypersensitivity to blood and blood products from the listed contraindications for GE Healthcare's Optison echocardiography contrast agent.

October 4, 2021

ViewRay submits 510(k) for updated version of MRIdian

By AuntMinnie.com staff writers

Image-guided radiation therapy vendor ViewRay has submitted a 510(k) application for an updated version of its MRIdian MRI-guided radiation therapy system.

October 3, 2021

U.S. government issues final rule on 'no surprises' billing

By AuntMinnie.com staff writers

The U.S. government on September 30 issued an interim final rule to implement the No Surprises Act, legislation going into effect in January 2022 that's designed to protect patients from unexpected bills when visiting out-of-network healthcare providers.

September 29, 2021

FDA issues draft guidance for electronic 510(k)s

By AuntMinnie.com staff writers

The U.S. Food and Drug Administration (FDA) has issued a draft guidance for electronic submission of 510(k) applications.

September 27, 2021

Zebra Medical wins FDA nod for CAC analysis software

By AuntMinnie.com staff writers

Artificial intelligence (AI) software developer Zebra Medical Vision has received U.S. Food and Drug Administration (FDA) 510(k) clearance for HealthCCSng, an AI-based software application for analysis of coronary artery calcium (CAC) on nongated CT studies.

September 26, 2021

FDA faces research hurdles in regulating AI for imaging

By Erik L. Ridley

What's taking so long for artificial intelligence (AI) algorithms to move into routine clinical use in radiology? Several regulatory bottlenecks could be holding AI back, according to a September 19 talk at the Conference on Machine Intelligence in Medical Imaging.

September 19, 2021

Us2.ai secures FDA nod for echocardiography AI software

By AuntMinnie.com staff writers

Artificial intelligence (AI) software developer Us2.ai has secured U.S. Food and Drug Administration (FDA) clearance for its Us2.v1 echocardiography image analysis software.

September 13, 2021

CMS to kill payment program for 'breakthrough' medical devices

By Brian Casey

The U.S. Centers for Medicare and Medicaid Services (CMS) is proposing to kill its Medicare Coverage of Innovative Technology program, which was developed under the Trump administration to accelerate Medicare reimbursement for "breakthrough" medical devices.

September 13, 2021

Siemens secures FDA clearance for Somatom X.ceed

By AuntMinnie.com staff writers

Siemens Healthineers has garnered U.S. Food and Drug Administration (FDA) clearance for its Somatom X.ceed CT scanner.

September 9, 2021

ASTRO calls proposed CMS cuts 'draconian'

By AuntMinnie.com staff writers

The American Society for Radiation Oncology (ASTRO) told the U.S. Centers for Medicare and Medicaid Services (CMS) that its proposed changes to the 2022 Medicare Physician Fee Schedule could lead to draconian cuts in cancer care.

September 8, 2021

Lunit garners regulatory clearance in Singapore

By AuntMinnie.com staff writers

Artificial intelligence software developer Lunit has received clearance from the Health Sciences Authority in Singapore for its Insight CXR and Insight MMG AI software applications.

September 6, 2021

Radiobotics gets FDA clearance for knee OA algorithm

By AuntMinnie.com staff writers

Artificial intelligence (AI) software developer Radiobotics has secured U.S. Food and Drug Administration 510(k) clearance for RBknee, an AI-based software application designed to aid in the diagnosis of knee osteoarthritis (OA) on radiography.

August 30, 2021

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