Medical Devices
News
news
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Philips and WellSpan Strike Seven-Year Imaging Alliance
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Royal Philips and WellSpan Health have announced a seven-year strategic alliance covering advanced imaging technology, joint research, and AI-driven care delivery across 12 hospitals in Central Pennsylvania and Northern Maryland.
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FDA Finalizes Human Factors Guidance for Medical Device Marketing Submissions
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The U.S. Food and Drug Administration (FDA) today finalized its guidance titled “Content of Human Factors Information in Medical Device Marketing Submissions,” originally issued in draft form in December 2022. The notice of availability was filed with the Federal Register on May 28, 2026, with formal publication scheduled for today. The document provides manufacturers and…
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UltraSight Study: AI Guidance Enables Novices to Perform Diagnostic-Quality Cardiac Ultrasound After One Day of Training
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A new peer-reviewed study published in European Heart Journal – Digital Health shows that clinicians with no prior ultrasound experience can acquire diagnostic-quality cardiac images after a single day of AI-guided training, raising new possibilities for bedside echo in resource-constrained settings.
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EUDAMED Goes Live as a Requirement: The Grace Period Ends Today
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As of May 28, 2026, the first four EUDAMED modules are mandatory across the EU. Actor registration, UDI/device registration, notified bodies and certificates, and market surveillance are now required for all relevant operators.
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Medline signs Prime Vendor agreement with Rural Medical Services
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Medline has signed a Prime Vendor agreement with Rural Medical Services, a non-profit federally qualified health center operating seven clinics across rural East Tennessee. The deal gives RMS access to Medline’s full medical-surgical portfolio and logistics network.
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FDA updates its recognized standards list: 45 entries added across 17 specialty areas
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Excerpt WordPress The FDA has updated its recognized standards database with 45 new entries effective May 25, 2026, spanning 17 medical device specialty areas. This release covers major standards bodies including ISO, IEC, ASTM, and ANSI/ADA, with notable updates in dental instrumentation, cardiovascular implants, orthopedic devices, and biocompatibility evaluation. Partial recognitions were granted for several…
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Lilly to Acquire Curevo in a Deal Worth Up to $1.5 Billion
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Eli Lilly announces the acquisition of Curevo Vaccine for up to $1.5 billion, betting on amezosvatein, a Phase 3-ready shingles vaccine with significantly improved tolerability over the current standard of care.
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Huntington’s Disease: Prilenia Transfers Clinical Trial Data to CHDI Foundation to Accelerate Research
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Prilenia Therapeutics has signed a data-sharing agreement with CHDI Foundation, donating placebo-arm clinical data from two Huntington’s disease trials.
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Aurora Sterilisation Secures €10.8M to Drive the Ecological Transition of Medical Device Sterilisation
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Aurora Sterilisation has secured €10.8 million in public funding to help medical device manufacturers transition to safer, greener sterilisation processes using natural plasma technology.
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Medtronic to acquire SPR Therapeutics for $650M, strengthening its chronic pain portfolio
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The global medtech leader is acquiring the peripheral nerve stimulation specialist behind the SPRINT® system, which demonstrated meaningful pain relief in over 6,100 real-world patients.