Press Releases

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

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

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

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

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

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

HealthpointCapital, the leading private equity firm focused exclusively on musculoskeletal healthcare, today announced the acquisition of a majority stake in ImmersiveTouch, Inc. ("ImmersiveTouch" or the "Company"). ImmersiveTouch's ImmersiveView™ platform is a patented, proprietary Virtual Reality (VR) and Augmented Reality (AR) software solution for surgical planning, navigation and patient-customized surgical guides. Currently focused on facial and t

QT Imaging Holdings, Inc. (OTCQB:QTIH), a medical device company engaged in research, development, and commercialization of innovative body imaging systems, is pleased to announce its latest image reconstruction software update release, version 4.4.0, which delivers a substantial reduction in the QTscan™ image processing time, improving user throughput and overall efficiency. The software update was developed leveraging NVIDIA’s L40 GPU, powered by the Ada Lovelace architecture.

Tivic Health® Systems, Inc, a diversified immunotherapeutics company developing treatments that stimulate immune pathways to treat disease, today announced it has completed all study visits in the Optimization Study for its patent pending, non-invasive cervical vagus nerve stimulation (ncVNS) device. Initial findings reinforce the importance of personalization for therapeutic efficacy. Tivic expects to release the study results later this year. The study was conducted by The Fei

Johnson & Johnson MedTech, a global leader in surgical technologies and solutions, today launched the PolyphonicTM AI Fund for Surgery to help develop AI solutions that solve challenges before, during, and after surgery. Joined by a coalition of companies including NVIDIA and Amazon Web Services (AWS), the initiative builds on the company’s work to advance AI that will help redefine modern surgical practices and improve patient outcomes. The Polyphonic AI Fund for Surgery