DOSIsoft announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market Planet Onco Dose software for its oncology and yttrium-90 (Y-90) microsphere SIRT 3-D dosimetry components.

Advanced visualization and artificial intelligence (AI) technology provider TeraRecon has successfully completed a U.S. Food and Drug Administration (FDA) regulatory review of its Northstar AI Results Explorer. TeraRecon said the technology and the determination are both firsts-of-kind in the medical imaging industry. Northstar is designed to work alongside the company’s EnvoyAI interoperability platform, which includes FDA-cleared third-party content listed on its EnvoyAI Exchange marketplace.

Northstar AI Results Explorer

Bay Labs announced that new data on the company’s first-of-its-kind deep learning investigational guidance software will be presented at the upcoming American Society of Echocardiography (ASE) 30th Annual Scientific Sessions, June 21-25 in Portland, Ore.

Merit Medical Systems Inc. announced it has acquired Brightwater Medical Inc., based in Temecula, Calif. Brightwater Medical’s primary product, the ConvertX, is a single device used to replace a series of interventional radiology devices and procedures used to treat severe obstructions of the ureter.

Zebra Medical Vision announced it has received its third U.S. Food and Drug Administration (FDA) 510(k) clearance for the company's HealthICH product. The new clearance covers an artificial intelligence (AI) alert for intracranial hemorrhage (ICH), based on head computed tomography (CT) scans.

United Imaging announced the first U.S. clinical installation of the uMI 550 Digital positron emission tomography/computed tomography (PET/CT) system. The second United Imaging PET/CT system to be installed in the U.S. in the last 30 days, the uMI 550 is now in use at Southwest X-Ray LP in El Paso, Texas.

DiA Imaging Analysis announced the presentation of two studies assessing the performance and accuracy of the company's LVivo EF artificial intelligence (AI)-based solution that generates fully automated left ventricular ejection fraction (LVEF). EF is a main indicator in assessing the global function of the left ventricle. Presently, many readers quantify EF visually or trace endocardial borders that may not be well defined, yielding high variability among results. LVivo EF aims to substantially reduce this variability by generating objective, accurate and fast AI-based EF.

Access to healthcare by rural-living Americans can be difficult. Part of the reason is the wide geographic expanse.

According to the U.S. Census Bureau, rural America covers about 97 percent of U.S. land. It is home to about 60 million Americans — about 19 percent of the U.S. population. Many travel 50, 60 or more miles to urban health care facilities to get specialty care or even a computed tomography (CT) or magnetic resonance (MR) exam.

 

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