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SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--ENZAMET Trial Shows Veracyte's Decipher Prostate Test Identifies Which Patients Benefit from Adding Chemotherapy in Metastatic Prostate Cancer...

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...

BOSTON--(BUSINESS WIRE)--A InterSystems, um fornecedor de tecnologia de dados criativos que alimenta mais de um bilhão de registros de saúde em todo o mundo, anunciou hoje que suas soluções de registro eletrônico de saúde (EHR) foram certificadas como Dispositivos Médicos de Classe sob a certificação de Regulamento (MDR) sob o Regulamento (UE) 2017/745. Esta aprovação marca o primeiro EHR nativo de IA totalmente unificado a obter a certificação MDR Classe IIa na União Europeia. Esta certificaçã...

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, 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...

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...