The FDA released draft regulatory framework and complimentary documents detailing its plans to streamline the review of digital health devices, including artificial intelligence (AI) technology, under its Software Precertification (Pre-Cert) initiative.

Montana-based Bozeman Health Deaconess Hospital paid $10 million to settle a federal lawsuit accusing its radiology department of fraud, according to unsealed court documents reported by the Bozeman Daily Chronicle.

Edward-Elmhurst Health is the first health system in the Chicagoland area to offer molecular breast imaging and comes just in time for Illinois' newly enacted breast density notification law, according to a report published Jan. 14 by Crain’s Chicago Business.

The results drive home the need to incorporate these risk factors during the shared-decision making process between patients and physicians when evaluating lung cancer screening options for high-risk groups, according to the study's authors.

Kheiron Medical, an artificial intelligence (AI) medical imaging startup based in London, is the latest company to announce its research efforts in using AI to identify signs of breast cancer from mammograms and help alleviate the U.K.’s current radiologist shortage, according to a recent article by the Financial Times.

CHICAGO & NASHVILLE, Tenn.--(BUSINESS WIRE)--Jan 6, 2019--GE Healthcare and Vanderbilt University Medical Center (VUMC) today announced a five-year partnership to enable safer and more precise cancer immunotherapies. Multiple diagnostic tools will be developed to help predict both the efficacy of an immunotherapy treatment and its adverse effects for a specific patient before the therapy is administered. This would allow physicians to better target immunotherapies to the right patients and avoid potentially damaging, ineffective and costly courses of treatments.

Breast-specific gamma imaging (BSGI) outperformed breast MRI in predicting a complete pathologic response to neoadjuvant chemotherapy (NAC) with breast cancer, according to research published online Jan. 8 in the American Journal of Roentgenology.

When incidental findings are detected, follow-up imaging is usually recommended. But when it comes to indeterminate abdominal findings, more than 36 percent of patients did not return for follow-up imaging, according to a single-center study published in the American Journal of Roentgenology.

A recent op-ed published by Morning Consult urged Democrats in the House and Senate to permanently repeal the 2.3 percent medical device tax in order bring down healthcare costs and promote innovation.

GREENVILLE, N.C. — RFPi Inc. has received 510(k) clearance from the U.S. Food and Drug Administration to begin marketing for use by surgeons in open surgery its iCertainty™ blood flow and perfusion imaging medical device.