Medical Devices News

BOCA RATON, Fla.--(BUSINESS WIRE)--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 comp...

MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--NeuroPace, Inc. (Nasdaq: NPCE), a medical device company focused on transforming the lives of people living with epilepsy, today announced that the Company will participate in the 2026 American Society for Stereotactic and Functional Neurosurgery (ASSFN) Meeting, taking place May 29 – June 2, 2026 in Cleveland, Ohio. At the meeting, NeuroPace will highlight the expanding role of responsive neuromodulation in epilepsy care, including long-term clinical out...

MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--NeuroPace, Inc. (Nasdaq: NPCE), a medical device company focused on transforming the lives of people living with epilepsy, today announced FDA approval of ECoG Assistant, its first AI-driven clinician-enabled feature. This milestone represents an important step in NeuroPace’s broader AI platform strategy, leveraging the world’s only long-term intracranial EEG dataset to transform how epilepsy is monitored and managed. ECoG Assistant: Treatment Insights Si...

CLICHY, France--(BUSINESS WIRE)--CorWave, a clinical-stage medical company pioneering innovative cardiac assist devices, announces that its Quality Management System has been certified by an independent notified body in accordance with the international ISO 13485 standard. The certification covers the design, development, manufacturing, distribution, and servicing of implantable Left Ventricular Assist Devices (LVADs). This certification marks a foundational regulatory milestone on the path to...

LATHAM, N.Y.--(BUSINESS WIRE)--AngioDynamics, Inc. (NASDAQ: ANGO), a medical technology company focused on restoring healthy blood flow in the body's vascular system, expanding cancer treatment options and improving patient quality of life, today announced that Palmetto GBA has issued a final Local Coverage Determination (LCD L40205) establishing Medicare coverage guidance for irreversible electroporation (IRE), the non-thermal ablation technology delivered by the Company's NanoKnife System, in...

SAN FRANCISCO--(BUSINESS WIRE)--Hims & Hers Health, Inc. (NYSE: HIMS), the leading health and wellness platform, today announced the expansion of Hims & Hers Benefits, adding eight new partners to the Hims & Hers exclusive program. Joining founding partners Prenuvo and Eight Sleep are Natural Cycles, MyFitnessPal, Ladder, PVOLVE Studios, HelloFresh, Factor, Flo Health, Dexcom, and iFIT - a carefully curated lineup spanning nutrition, fitness, women's health, metabolic monitoring, an...

SANTA CLARA, Calif.--(BUSINESS WIRE)--Coredio, a digital health company developing the first software-as-a-medical-device (SaMD) platform dedicated to heart failure (HF) hemodynamic assessment, today announced that the U.S. Food and Drug Administration has granted its Cardiac Performance Simulation Engine (CPSE™) Breakthrough Device Designation and accepted the platform into the FDA’s Total Product Life Cycle Advisory Program (TAP). CPSE™ is a software-only platform designed to deliver catheter...

ROCHESTER, Minn.--(BUSINESS WIRE)--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 it...

CHELMSFORD, Mass.--(BUSINESS WIRE)--From local fields to national venues, youth sports play out every day across the country. Today, ZOLL® Medical, an Asahi Kasei company, announced the next phase of its national Anything Can Happen. Anyone Can Help.™ campaign, aimed at strengthening cardiac emergency readiness where young athletes play. Sudden cardiac arrest remains the leading cause of death among young athletes1, and approximately 356,000 out-of-hospital cardiac arrests occur nationwide each...

PALO ALTO, Calif.--(BUSINESS WIRE)--Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the company and its research collaborators will present 38 abstracts, as well as one oral presentation in partnership with Pfizer, showcasing advances in methylation-based tumor classification and liquid biopsy technology at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois taking place May 29 – June 2, 2026. Key data that will be prese...