FDA

News and Updates by the Food and Drugs Administration (FDA)

Quest Diagnostics Launches Personal Health Coaching on questhealth.com for Enhanced Wellness Management

Individualized health coaching options are now available for purchase on questhealth.com. Offered through Pack Health, a subsidiary of Quest Diagnostics known for its evidence-based patient interaction services, the platform pairs users with certified health coaches. These professionals offer focused support, […]

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ShiraTronics Kicks Off FDA IDE Trial for Implantable Neuromodulation Therapy

Minneapolis-based ShiraTronics has officially commenced its pivotal FDA investigational device exemption (IDE) trial, aiming to assess its neuromodulation therapy for chronic migraines. The RELIEV-CM2 study marks the beginning of in-depth evaluation regarding the long-term safety and performance of this treatment.

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Edwards Forecasts 10% Expansion in First Year Solely Dedicated to Structural Heart Innovations

Edwards Lifesciences (NYSE:EW) shared its ambitious growth trajectory as it transitions into a dedicated structural heart enterprise by 2025. This pivot follows the $4.2 billion divestment of its Critical Care division to BD, inciting a 3% global workforce reduction and

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GE HealthCare Seeks FDA 510(k) for AI-Enhanced CleaRecon DL to Boost Interventional Suite Imaging

GE HealthCare, renowned for its innovations in medical technology, pharmaceutical diagnostics, and digital solutions, has submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for approval of CleaRecon DL. This cutting-edge deep learning technology aims to uplift

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Orphan Drug Status Awarded to RESTEM’s ULSC Initiative by the FDA for Polymyositis and Dermatomyositis Treatment

RESTEM, a biotechnological firm at the clinical-stage, dedicated to crafting innovative cell therapies that are readily available and aim to regulate the immune response, has disclosed that the United States Food and Drug Administration (FDA) has bestowed Orphan Drug Designation

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Dentalkart Secures Rs. 85 Crore Funding from International Investors for Growth and Subsidiary Expansion

Dentalkart, the pioneering and largest online hub for dental products in India, has garnered Rs. 85 crore in a recent financing round. This investment, headed by international investors Malabar Investment and Whiteoak, underscores the company’s dedication to transforming the dental

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Everest Medicines Reports Promising Outcomes from Phase 1b/2a Study of Innovative BTK Inhibitor, EVER001 for Primary Membranous Nephropathy Treatment

Everest Medicines, a biopharmaceutical company committed to pioneering the discovery, development, production, and commercialization of novel therapies, has shared promising outcomes from their ongoing phase 1b/2a trial evaluating EVER001 for primary membranous nephropathy (pMN). A cutting-edge covalent reversible Bruton’s tyrosine

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