Press Releases

Scanogen Inc., a molecular diagnostics company pioneering next-generation technologies for infectious disease detection, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the company’s rapid assay designed to identify bloodstream infection pathogens directly from patient samples. The FDA’s Breakthrough Device designation recognizes technologies that have the potential to provide more effective diagnosis or tr

Accuray Incorporated announced today that 5D Clinics has treated the first patients in the city of Melbourne, Australia, using the CyberKnife S7™ System. 5D Clinics and joint venture partner Icon Group will open and operate CyberKnife System centers across Australia*, with the goal of making it easier for cancer patients to obtain state-of-the-art precision robotic stereotactic body radiation therapy (SBRT) and stereotactic radio surgery (SRS) treatments closer to home. With an ini

Tebra, a leading healthcare technology platform, today announced the launch of AI Review Replies and AI Review Insights, two groundbreaking artificial intelligence features integrated natively within its EHR+ Patient Experience package. These industry-first innovations make Tebra the only EHR software solution offering native AI-powered sentiment analysis and automated review response capabilities, positioning healthcare practices to better manage their online reputation while maint

AtaCor Medical, Inc., a privately-held medical device company focused on transforming cardiac rhythm management systems, announced today that it has entered into a financing of up to $75 million. The proceeds will fund the company's U.S. FDA Pivotal Study evaluating AtaCor's parasternal extravascular implantable cardioverter-defibrillator (EV-ICD) system for the treatment of life-threatening ventricular tachyarrhythmias. "There is a clear and growing need for extravascu

ScreenPoint Medical today announced that its Transpara® breast imaging AI solution has been selected as the technology of choice for the PRISM (Pragmatic Randomized Trial of Artificial Intelligence for Screening Mammography) Trial, a landmark randomized controlled trial funded by the Patient-Centered Outcomes Research Institute (PCORI). Fueled by a $16 million award, this is the first large-scale trial in the United States to rigorously evaluate the role of artificial intelligence (AI) in

FlyteHealth, a leader in virtual cardiometabolic care, and Heartbeat Health, the nation's leading virtual-first cardiology provider, today announced a strategic partnership, launching a bundled program combining their expertise into a seamless offering. This solution creates one entry point for employers and payors to provide comprehensive care—from managing conditions like pre-diabetes, hypertension, and hyperlipidemia with FlyteHealth to addressing cardiovascular disease

Stereotaxis a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced successful first procedures by physicians at Erasmus University Medical Center in Rotterdam, The Netherlands, using the advanced Genesis Robotic Magnetic Navigation System. “We have long recognized the clinical benefits of robotics, and are delighted to be the first in The Netherlands to make the Genesis robotic system available to cardiovascular

TransMedics Group, Inc, a medical technology company that is transforming organ transplant therapy for patients with end-stage lung, heart, and liver failure, today announced a strategic collaboration with Mercedes-Benz Group AG to deploy a first-of-its-kind fleet of modern, purpose-built Mercedes-Benz V-class vehicles dedicated exclusively to organ transportation across Italy. The strategic collaboration supports TransMedics' broader commercial strategy to replicate its success

HeartcoR Solutions, a leading core lab focused on the collection, analysis, and reporting of cardiac safety and other physiological data in clinical trials, announced today exciting growth in its suite of remote monitoring technology. The addition of the TempTraq® device from Blue Spark Technologies, Inc., and the PCA 500 from QT Medical allows HeartcoR to create a one-stop shop for clinical trial sponsors.  "Healthcare innovation relies on the ability to prove the saf

Kelyniam Global, Inc. (Kelyniam), a leading provider of custom cranial and craniofacial implant solutions, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Fusion™ Cranial and Craniofacial Implants. These implants are crafted from a unique combination of Biphasic Calcium Phosphate (BCP) reinforced with Polyether Ether Ketone (PEEK), marking a groundbreaking advancement in implant technology. This 510(k) clearance ma