Regulatory: Page 17

Release of final Medicare payment rates raises ire of physician groups

By Brian Casey

A number of healthcare groups are protesting final rules on Medicare 2022 payment released late on November 2 by the U.S. Centers for Medicare and Medicare Services. The rules lock in a number of payment cuts for healthcare providers.

November 1, 2021

Global regulators unveil initiative on development of safe AI

By AuntMinnie.com staff writers

The U.S. Food and Drug Administration (FDA), Health Canada, and the U.K.'s Medicines and Healthcare products Regulatory Agency have jointly issued a list of guiding principles for developers of medical devices based on artificial intelligence (AI) and machine learning.

October 26, 2021

NIH invests $75M to advance data science in Africa

By AuntMinnie.com staff writers

The U.S. National Institutes of Health (NIH) is investing $74.5 million over five years to advance data science and trigger health discoveries in Africa.

October 26, 2021

Sofie submits IND application for pancreatic PET agent

By AuntMinnie.com staff writers

Molecular imaging developer Sofie Biosciences has submitted an investigational new drug application (IND) with the U.S. Food and Drug Administration for a radiopharmaceutical targeting the fibroblast activation protein inhibitor.

October 11, 2021

Delphinus gets FDA nod for 3D whole-breast US system

By Amerigo Allegretto

The U.S. Food and Drug Administration (FDA) has approved Delphinus Medical Technologies' new 3D whole-breast ultrasound system for detecting cancer in women with dense breasts.

October 11, 2021

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

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