SurGenTec, LLC, a leader in innovative spine and orthopedic technologies, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) SurGenTec, LLC, a leader in innovative spine and orthopedic technologies, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its ION-C™ navigation instruments for use with the ION-C™ posterior cervical facet fixation implant. The system is engineered for compatibility w

Inspirity Health Partners (IHP) has entered into a strategic, multi-year agreement with Tallahassee Memorial HealthCare (TMH) to advance and integrate TMH’s supply chain capabilities through a collaborative, high-performance partnership model. With a well-established category management structure, disciplined operational processes and strong clinical engagement, TMH joins Inspirity from a position of strength. Through this new collaboration, TMH will expand its capabilities by

Cardiosense, a healthcare technology company focused on heart failure care, today announced that the U.S. Food & Drug Administration (FDA) has granted De Novo classification for its PCWP Analysis Software™, a first-in-class technology to estimate a key indicator of heart health noninvasively. With this authorization, Cardiosense has a clear path forward in supporting clinicians who manage heart failure by providing critical data to improve therapy and avoid prolonged hospitalization

AiM Medical Robotics, a leading developer of advanced robotic systems for MRI-guided neurosurgery, today announced a collaboration agreement with Siemens Healthineers for the implementation of an interface enabling AiM’s robotic platform to operate with MRI systems from Siemens Healthineers. The interface supports the integration of AiM’s compact, MRI-compatible robotic stereotactic neurosurgery system and associated workflow with the market-leading Siemens Healthineers’ MAG

Spectral AI has received De Novo Classification clearance from the U.S. Food and Drug Administration for its DeepView System, allowing the company to begin commercial distribution in the United States. The DeepView System is designed for use in burn care and can be used in burn centres, trauma centres and emergency departments. The platform uses artificial intelligence to support faster and more accurate treatment decisions in wound care. According to Spectral AI, the tech

InterSystems, a creative data technology provider powering more than one billion health records globally, today announced that its electronic health record (EHR) solutions have been certified as Class IIa Medical Devices under Regulation (MDR) certification under Regulation (EU) 2017/745. This approval marks the first fully unified AI-native EHR to achieve MDR Class IIa certification in the European Union. This certification demonstrates that InterSystems AI-native EHR meets stringe

Jupiter Endovascular, Inc. today announced that the SPIRARE II pivotal trial evaluating the use of the company’s Vertex™ Pulmonary Embolectomy System in patients with acute, intermediate-risk pulmonary embolism (PE) met both of its primary endpoints, demonstrating meaningful heart recovery and clinical safety. Late-breaking data from the trial were presented today by Catalin Toma, MD, Director of Interventional Cardiology at the UPMC Heart and Vascular Institute and the trial&rsqu

Autonomix Medical, Inc. a medical device company dedicated to advancing precision nerve-targeted treatments, today announced the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 12,544,131 (the “131 patent”), titled “Systems, Methods, and Devices for Monitoring and Treatment of Tissues Within And/Or Through a Lumen Wall.” The newly issued patent strengthens the Company’s growing global intellectual property portfolio, which i

Amplitude Vascular Systems (AVS), a medical device company recently acquired by Stryker and focused on treating severely calcified arterial disease, today announced the enrollment of the first patient in its first-in-human (FIH) study for Pulsatile Intravascular Lithotripsy (PIVL) therapy in a coronary indication. The POWER CAD I study will evaluate the feasibility of the Pulse IVL™ System for the treatment of patients with moderate to severely calcified coronary arterial dise

Viz.ai, the leader in AI-powered disease detection and intelligent care coordination, today announced the launch of the Viz Pulmonary™ Suite, an integrated AI-powered solution in the Viz.ai enterprise platform, designed to help health systems streamline care delivery for pulmonary conditions. The suite brings acute and chronic pulmonary workflows together in a single solution, giving clinicians a more streamlined way to manage patients to help get them on guideline-directed care.