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Medical Devices
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NeuroPace to Highlight Expanding Role of Responsive Neuromodulation at the 2026 American Society for Stereotactic and Functional Neurosurgery (ASSFN) Meeting

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...
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NeuroPace Announces FDA Approval of ECoG Assistant™, Advancing AI-Driven Epilepsy Care

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...
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CorWave franchit une étape réglementaire majeure avec la certification ISO 13485 pour l'ensemble de ses activités

CLICHY, France--(BUSINESS WIRE)--CorWave, société pionnière dans le développement de dispositifs d’assistance cardiaque innovants, annonce la certification de son système de management de la qualité par un organisme notifié indépendant, conformément à la norme internationale ISO 13485. La certification obtenue couvre la conception et le développement, la fabrication, la distribution et le service-après-vente de dispositifs d’assistance ventriculaire gauche implantables (LVAD). L’entreprise fran...
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CorWave Achieves Major Regulatory Milestone with ISO 13485 Certification Across its Entire Operations

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...
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AngioDynamics Expands Patient Access to NanoKnife IRE for Prostate and Liver Cancer as Medicare Coverage Framework Takes Effect

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...
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Hims & Hers Expands Benefits for Active Subscribers With Eight New Health and Wellness Partners

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...
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FDA Grants Coredio Breakthrough Designation for AI Platform Bringing Advanced Heart Failure Assessment Beyond the Hospital

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...
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Tallahassee Memorial HealthCare and Inspirity Health Partners Launch Strategic Supply Chain Partnership

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...
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ZOLL® Expands “Anything Can Happen. Anyone Can Help.”™ to Strengthen Cardiac Emergency Readiness Across Youth Sports Nationwide

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...
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Guardant Health and Collaborators to Present 38 Abstracts Highlighting Breadth and Expanded Clinical Utility of Guardant Liquid Biopsy Tests Powered by InfinityAI at 2026 ASCO Annual Meeting

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...