Press Releases

Bracco Imaging S.p.A., a global leader in diagnostic imaging, and Subtle Medical, Inc., a pioneering innovator in artificial intelligence (AI)-powered image acquisition, announced today that AiMIFY™, their jointly developed AI-powered software for magnetic resonance imaging (MRI) of the brain, has received the CE (Conformité Européenne) Mark under the European Medical Device Regulation (MDR). This regulatory milestone confirms the compliance of AiMIFY™ with EU safety

Viz.ai, the leader in AI-powered disease detection and intelligent care coordination, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for Viz Subdural Plus, the first and only comprehensive solution for quantifying the size of collections like subdural hemorrhages (SDH) in the subdural space on non-contrast computed tomography (NCCT) images. The Viz Subdural Plus module is designed to support clinical-decision making by automatically labeling subdural

Hyperfine, Inc. the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared AI-powered portable MRI system for the brain—the Swoop® system—announced the appointments of Rob Fasciano, PhD, as Chief Regulatory and Quality Officer, and Rafael O’Halloran, PhD, as Vice President of Technology. These leadership additions were instrumental in the development of the recently FDA-cleared Optive AI™ software and the new, next-gene

Zeto, Inc. is proud to announce the success of a new onsite EEG program at Huntsville Memorial Hospital (HMH) that has helped reduce emergency room patient transfers and improve access to neurological diagnostics for the Huntsville community and surrounding areas. As the only hospital within a 30-mile radius, HMH now offers critical services that previously required transfers to larger facilities in Conroe, The Woodlands, or Houston. An EEG (electroencephalogram) is a test that meas

Zeto, Inc. is proud to announce the success of a new onsite EEG program at Huntsville Memorial Hospital (HMH) that has helped reduce emergency room patient transfers and improve access to neurological diagnostics for the Huntsville community and surrounding areas. As the only hospital within a 30-mile radius, HMH now offers critical services that previously required transfers to larger facilities in Conroe, The Woodlands, or Houston. An EEG (electroencephalogram) is a test that meas

Masimo today announced the findings of a randomized clinical trial published in JAMA Pediatrics in which Dr. Yasuko Nagasaka and colleagues at Tokyo Women’s Medical University demonstrated the ability of electroencephalogram (EEG)-guided anesthesia, using Masimo SedLine® Brain Function Monitoring, to improve anesthesia administration in children undergoing surgery.1 The researchers found that the use of SedLine led to a significant reduction in the amount of a commonly used inh

CIVIE, a leading healthcare technology and services company, today announces the official launch of RadPod, an AI-driven, on-demand radiology platform designed to transform how, when and where radiologists work. RadPod was developed to align the interests of radiologists, hospital systems and the latest in healthcare technology to ensure the practice of radiology is a win-win-win. Powered by CIVIE’s cutting-edge AI technology, radiologists can read and interpret medical imagin

CRH Medical Corporation (“CRH”), a leading provider of products and services for gastrointestinal (GI) providers and a wholly owned subsidiary of WELL Health Technologies Corp. (“WELL”), has announced a strategic partnership with WovenX Health (“WovenX”), a leader in integrated virtual specialty care. Together, they aim to deliver integrated, next-generation GI practice solutions designed to resolve persistent challenges surrounding patient access and opera

Microbot Medical Inc. developer of the innovative LIBERTY Endovascular Robotic System, today announced the continued expansion of its commercial team in preparation for the anticipated U.S. launch of the LIBERTY System, which is projected during the third quarter of 2025. The Company remains actively engaged with the U.S. Food and Drug Administration (FDA), with a 510(k) decision now expected during the third quarter of this year. This updated FDA decision timeline remains within the FDA&rsqu

Foldax® Inc., a leader in heart valve innovation, today announced that the Indian Central Drugs Standard Control Organization (CDSCO) approved its TRIA™ Mitral Valve. Dolphin Life Science India LLP will locally manufacture the TRIA Mitral Valve in India. Traditional valves made from animal tissue are prone to calcification and degradation, limiting their durability and often leading to repeat surgeries, especially for younger patients. Mechanical valves, while durable, are