Press Releases
9 July 2025
Masimo a global medical technology company that develops and manufactures innovative noninvasive monitoring solutions, has joined the American Heart Association Center for Health Technology & Innovation’s (the Center) Innovators’ Network. The Center is focused on building and fostering health technology relationships to develop innovative and scalable solutions. The Innovators’ Network is a health care technology consortium that connects entrepreneurs, provider
Read more...Xtant Medical Holdings, Inc. a global medical technology company focused on surgical solutions for the treatment of spinal, orthopedic, and woundcare disorders, today announced that the company has entered into agreements to sell certain Coflex® and CoFix® interlaminar stabilization implant assets and all OUS entities of Paradigm Spine GmbH, to Companion Spine, LLC, a French-American company fully dedicated to posterior dynamic spine stabilization and motion preservation sy
Read more...8 July 2025
Boston Scientific Corporation has received U.S. Food and Drug Administration (FDA) approval to expand the instructions for use (IFU) labeling for the FARAPULSE™ Pulsed Field Ablation (PFA) System. The updated labeling now includes approval for the system in the treatment of drug refractory, symptomatic persistent atrial fibrillation (AF), an arrythmia in which the heart beats abnormally for at least seven days. AF affects an estimated 59 million people worldwide and many
Read more...Medtronic, a global leader in healthcare technology, today announced that it has treated the first patient in its SPYRAL GEMINI Pilot program (including 'OFF MED’ and 'ON MED’ studies).* The first patient was treated by Dr. Barry Bertolet at Cardiology Associates of North Mississippi and North Mississippi Medical Center in Tupelo. With this trial, Medtronic intends to investigate the feasibility of combined denervation of both the renal and common hepatic (liver) arteries
Read more...Moon Surgical, today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) for two major advancements to its Maestro System: connectivity of the platform to power the Maestro Insights product and a Predetermined Change Control Plan (PCCP) to evolve its AI-powered ScoPilot product. With this clearance, Maestro Systems can now have active Wi-Fi and 5G connectivity, enabling seamless data exchange with Maestro Insights—Moon's cloud-based platform that gi
Read more...3 July 2025
Predictmedix AI Inc. a leader in artificial intelligence-driven health screening solutions, is expanding into the direct-to-consumer market with a mobile solution designed to deliver rapid, non-invasive diabetic screening — with India identified as the initial launchpad for this transformative initiative. Leveraging the company’s proprietary AI technology, the platform is intended to empower millions with instant access to diabetic risk assessments using only a smartphone, elimina
Read more...3 July 2025
Medtronic and Philips, two global leaders in healthcare technology, announced a significant step forward in their strategic collaboration in patient monitoring, signing a multi-year partnership agreement focused on improving patient care and expanding access to technology. Medtronic and Philips have a strong history of partnership in monitoring since 1992 and continue to work together to provide combined leading technologies for individual monitoring parameters. The new st
Read more...2 July 2025
ONWARD Medical N.V. the leading neurotechnology company pioneering therapies to restore movement, function, and independence in people with spinal cord injury (SCI) and other movement disabilities, today announced the submission of two major regulatory applications for its ARC-EX System. The Company has submitted a 510(k) application to the US Food and Drug Administration (FDA) seeking clearance to expand its indication for home use. In parallel, ONWARD has filed an application with the
Read more...Immunovia, the pancreatic cancer diagnostics company, today announced that the American Medical Association (AMA) Current Procedual Terminology (CPT) Editorial Panel has assigned a CPT Proprietary Laboratory Analyses (PLA) code for the company's new PancreaSure test. The CPT code for PancreaSure is a Proprietary Laboratory Analyses (PLA) code and becomes effective October 1, 2025 and can then be used for the submission of healthcare claims to third-party payers in the US. It ena
Read more...PathAI, a global leader in artificial intelligence (AI) and digital pathology solutions, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for AISight® Dx*—its digital pathology image management system—for use in primary diagnosis in clinical settings. Building on the initial 510(k) clearance for AISight Dx(Novo) in 2022, this latest milestone underscores the platform’s continuous innovation and PathAI’s commitme
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