Canon Medical’s AI-Powered, Premium Large Bore CT Receives FDA Clearance

Canon Medical Systems USA, Inc. has received FDA clearance for the Aquilion Exceed LB CT system, giving clinicians the opportunity to see more during radiation therapy planning for accuracy, precision and speed.

FDA Clears MULTIX Impact C Ceiling-Mounted DR System

Siemens Healthineers has announced the Food and Drug Administration (FDA) clearance of the MULTIX Impact C ceiling-mounted digital radiography (DR) system as well as the MULTIX Impact VA20, a new version of the established floor-mounted parent DR system.

FDA Approves Seno Medical’s Breast Cancer Diagnostic Technology

The Center for Devices and Radiological Health (CDRH) of the U.S. Food & Drug Administration (FDA) has granted Texas-based Seno Medical Instruments Inc.

Philips to Acquire Capsule Technologies Inc.

Royal Philips has signed an agreement to acquire Capsule Technologies Inc., a provider of medical device integration and data technologies for hospitals and healthcare organizations.

iCAD Reports Over 1,000 Licenses Sold as Part of ProFound AI Sales

iCAD Reports Over 1,000 Licenses Sold as Part of ProFound AI SalesiCAD Inc. has reported that over 1,000 licenses have been sold as part of ProFound AI sales since the products were launched, signaling the rapid and wide-spread adoption of the cancer detection software solution built on artificial intelligence (AI). The sales have been distributed across all major mammography system vendors and enterprise-wide viewing applications with a significant percentage to date sold to hospitals and imaging centers with GE and Siemens, as well as facilities with more than one imaging system vendor, including Hologic and Fuji.

“The solid momentum is led by the company’s growing customer base and demand for its expanded suite of leading breast health AI solutions, including ProFound AI for both Digital Breast Tomosynthesis (DBT) and 2D mammography, and interest in the recently introduced ProFound AI Risk, which is helping to transform breast cancer screening from age-based screening to risk-adapted precision screening, individualized for each woman,” according to a news release.

“iCAD offers the full continuum of breast health AI products – both for the detection of current breast cancers and for future risk assessment,” said Michael Klein, chairman and CEO of iCAD. “We do so on a non-exclusive, open architecture basis, therefore allowing all global customers access to the best of breed AI software available. Of significant note is that no other breast AI solution has been shown to improve radiologists’ clinical performance when reading DBT more so than ProFound AI. Specifically, our high-performing cancer detection and workflow solution offers the highest cancer detection rate, the lowest false positive rate and a dramatic 52.7% reduction in radiologists’ reading time, representing a high level of clinical significance and advantage.”

ProFound AI Risk is the first and only commercially available clinical decision support tool to provide an accurate two-year breast cancer risk estimation based solely on a screening mammogram, the release adds. Compelling research published in the peer-reviewed journal, Radiology concluded that the ProFound AI Risk model is effective at identifying women at high likelihood of being diagnosed with breast cancer within two years of a negative screening mammogram and in possible need of supplemental screening.

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