ECI

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🚨 Breaking News in Healthcare: Cepheid Wins FDA Nod for Fingerstick Hepatitis C Test! 🚨   On June 27, 2024, Cepheid made a groundbreaking announcement: they've received FDA de novo authorization for the first molecular test in the U.S. that detects hepatitis C virus RNA directly from fingerstick blood samples. 🩸🧬   This revolutionary test enables healthcare professionals to diagnose hepatitis C at the point of care, potentially allowing patients to be diagnosed and start treatment during the same visit! 🏥✨   Key Points: - 🔄 Cepheid’s authorization sets special controls for other companies to bring similar tests to market via the 510(k) pathway. - ⏱️ Previous testing required sending samples to central labs, making diagnosis a multi-step process. Cepheid’s test streamlines this, delivering results within one hour. - 🚑🔬 The Xpert HCV test runs on Cepheid’s Genexpert Xpress System, available in settings like substance use disorder treatment sites, correctional facilities, and syringe service programs.   Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, emphasized that this could lead to hundreds of thousands more hepatitis C patients being diagnosed and treated, preventing disease progression and further spread of the virus. 🦠💊   This marks a significant step forward in the fight against hepatitis C, making diagnosis and treatment more accessible and efficient. Please spread the word. 🌍💉 My company, ECI, specializes in diagnostic and medical device consulting in QA, Audits, Regulatory, post-market surveillance, validations, M&A integrations, and more.   Any questions, please DM me!   #Diagnostic #Innovation #HepatitisC #FDA #Cepheid #MedicalAdvancement #PublicHealth

We're #hiring a new Director of Business Development in United States. Apply today or share this post with your network.

𝗠𝗗𝗖𝗚 𝟮𝟬𝟮𝟬-𝟭𝟲 𝗨𝗽𝗱𝗮𝘁𝗲𝗱 𝘁𝗼 𝗥𝗲𝘃𝗶𝘀𝗶𝗼𝗻 𝟯 - 𝗚𝘂𝗶𝗱𝗮𝗻𝗰𝗲 𝗼𝗻 𝗖𝗹𝗮𝘀𝘀𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻 𝗥𝘂𝗹𝗲𝘀 𝗳𝗼𝗿 𝗶𝗻 𝘃𝗶𝘁𝗿𝗼 𝗗𝗶𝗮𝗴𝗻𝗼𝘀𝘁𝗶𝗰 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲𝘀 𝘂𝗻𝗱𝗲𝗿 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗶𝗼𝗻 (𝗘𝗨) 𝟮𝟬𝟭𝟳/𝟳𝟰𝟲 The EU Commission recently published an update by the Medical Device Coordination Group (MDCG) of MDCG 2020-16 Rev.3 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746. This guidance addresses the classification of in vitro diagnostic medical devices (IVDs) and provides clarifications on the classification rules as set out under Annex VIII. A summary of the revisions include: 🔹Definitions: Addition of ‘kit’ definition (means a set of components that are packaged together and intended to be used to perform a specific in vitro diagnostic examination, or a part thereof). 🔹Rule 3(a): Revision of examples of devices intended for detecting the presence of, or exposure to, a sexually transmitted agent. 🔹Rule 4(a): Revised guidance on devices intended for self-testing which are Class C except for pregnancy, fertility, glucose, erythrocytes, leucocytes cholesterol tests and urine analysis for bacteria which are Class B. 🔹Rule 5(c): Revised guidance on specimen receptacles. Those intended only for specimen collection by lay persons are not considered devices for self-testing. 🔹Rule 6: Minor revision of example of devices not covered by the classification rules (1, 2, 3, 4 or 5). 👉 Read more: https://lnkd.in/dbM-9n6r

𝗛𝗮𝗿𝗻𝗲𝘀𝘀𝗶𝗻𝗴 𝗣𝗮𝘁𝗶𝗲𝗻𝘁 𝗜𝗻𝘀𝗶𝗴𝗵𝘁𝘀 𝗳𝗼𝗿 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗜𝗻𝗻𝗼𝘃𝗮𝘁𝗶𝗼𝗻 - 𝗖𝗼𝗻𝗾𝘂𝗲𝗿𝗶𝗻𝗴 𝗖𝗮𝗿𝗱𝗶𝗮𝗰 𝗖𝗼𝗻𝗱𝗶𝘁𝗶𝗼𝗻𝘀: 𝗟𝗲𝘀𝘀𝗼𝗻𝘀 𝗳𝗿𝗼𝗺 𝗛𝗲𝗶𝗱𝗶 𝗗𝗼𝗵𝘀𝗲 Hear Heidi Dohse's inspiring story on Tuesday, July 9th, as she discusses her personal journey in overcoming cardiac disease and harnessing patient insights for medical device innovation with Gregory Austin, ECI. This session is for cardiac patients, medical device engineers/executives/marketers and more. It's about interacting with customer-patients in the R&D process and overcoming difficult health challenges. You will have the opportunity to interact with Heidi to understand more about medical device product development, technology, and overcoming health problems, especially heart💝problems. 👇Read more about this session and register using the link below. We hope you can join us tomorrow! 📅 Date: Tuesday, July 9 ⏰ Time: 12:00pm - 12:30pm EDT 🔗 Register: https://lnkd.in/eKZfSJHp #medicaldevice #innovation #research #development

𝗙𝗗𝗔 𝗶𝘀𝘀𝘂𝗲𝘀 𝗗𝗿𝗮𝗳𝘁 𝗚𝘂𝗶𝗱𝗮𝗻𝗰𝗲 𝘁𝗼 𝗵𝗲𝗹𝗽 𝘀𝘁𝗿𝗲𝗮𝗺𝗹𝗶𝗻𝗲 𝗱𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 𝗼𝗳 𝗱𝗿𝘂𝗴 𝗱𝗲𝗹𝗶𝘃𝗲𝗿𝘆 𝗱𝗲𝘃𝗶𝗰𝗲𝘀   On June 28, 2024, the U.S. Food and Drug Administration (FDA) announced the draft guidance, 𝘌𝘴𝘴𝘦𝘯𝘵𝘪𝘢𝘭 𝘋𝘳𝘶𝘨 𝘋𝘦𝘭𝘪𝘷𝘦𝘳𝘺 𝘖𝘶𝘵𝘱𝘶𝘵𝘴 𝘧𝘰𝘳 𝘋𝘦𝘷𝘪𝘤𝘦𝘴 𝘐𝘯𝘵𝘦𝘯𝘥𝘦𝘥 𝘵𝘰 𝘋𝘦𝘭𝘪𝘷𝘦𝘳 𝘋𝘳𝘶𝘨𝘴 𝘢𝘯𝘥 𝘉𝘪𝘰𝘭𝘰𝘨𝘪𝘤𝘢𝘭 𝘗𝘳𝘰𝘥𝘶𝘤𝘵𝘴. The guidance is intended to facilitate and streamline development of stand-alone devices, and combination products with device constituent parts, intended to deliver drugs and biological product. It also provides transparency, consistency, and predictability in the type of information to ensure that a device’s drug-delivery function consistently performs as intended. Examples are also provided for potential essential drug delivery output (EDDOs) for several product types including prefilled syringes, injectors, nasal sprays, and inhalation devices   The draft guidance is currently made available for public comments. The comment period is scheduled to close on September 29, 2024 and FDA will finalize the guidance document considering the received comments. 👉 Read more: https://lnkd.in/eE_GW3Fz

🚀 LinkedIn Live Announcement! 🚀 Join me for a LinkedIn Live next Tuesday, the 9th at 12pm ET, sponsored by ECI! 🎙️ Special Guest: Heidi Dohse, founder of Tour de Heart 🏥 Inspirational story from a cardiac patient and athlete 🏃♀️ Overcame health challenges with numerous pacemakers and open-heart surgery 💪 Completed an Ironman in 2019 using medical and wearable devices to train Don't miss this compelling and motivational session, even if you're not into medical devices. Heidi's journey is truly inspiring! 🌟 📅 Save the Date: Tuesday, the 9th ⏰ Time: 12:00 pm EDT Please REGISTER here: https://lnkd.in/geGfHgum #LinkedInLive #Inspiration #MedicalDevices #CardiacHealth #ECI

Upcoming ECI LinkedIn Live → 𝗛𝗮𝗿𝗻𝗲𝘀𝘀𝗶𝗻𝗴 𝗣𝗮𝘁𝗶𝗲𝗻𝘁 𝗜𝗻𝘀𝗶𝗴𝗵𝘁𝘀 𝗳𝗼𝗿 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗜𝗻𝗻𝗼𝘃𝗮𝘁𝗶𝗼𝗻 - 𝗖𝗼𝗻𝗾𝘂𝗲𝗿𝗶𝗻𝗴 𝗖𝗮𝗿𝗱𝗶𝗮𝗰 𝗖𝗼𝗻𝗱𝗶𝘁𝗶𝗼𝗻𝘀: 𝗟𝗲𝘀𝘀𝗼𝗻𝘀 𝗳𝗿𝗼𝗺 𝗛𝗲𝗶𝗱𝗶 𝗗𝗼𝗵𝘀𝗲 Hear Heidi Dohse's inspiring story as she discusses her personal journey in overcoming cardiac disease and harnessing patient insights for medical device innovation with Gregory Austin. 👇Read more about this session and register using the link below. We hope you can join us! 📅 Date: Tuesday, July 9 ⏰ Time: 12:00pm - 12:30pm EDT 🔗 Register: https://lnkd.in/eKZfSJHp #medicaldevice #innovation

🚀 Quick Review: FDA CDRH Update from MedCon 2024! 🚀   Here's a summary of the insightful updates shared by Jeff Shuren, FDA CDRH Director:   🔹 Novel Device Authorizations: 5-fold increase, with 2023 being a strong year!   🔹 Upcoming Digital Health Actions:  - New draft guidance for AI/ML lifecycle management  - Authorized 700 new AI technologies  - New Real World Evidence Draft Guidance   🔹 NEST Initiative: Improving medical device evaluation through real-world evidence collection.   🔹 IMDRF: 7 new members, streamlining IVD clinical evidence documents, and adding AI lifecycle management.   🔹 MDSAP: 24,930 audits since 2018, enhancing global medical device oversight.   🔹 QMSR Final Rule: Harmonizing QSR with ISO 13485:2016. Transition period until Feb 2026.   🔹 TAP Program: FDA's advisory role can cut up to a year off med device development time.   🔹 Recalls: Trending down but still significant. Focus areas: Process Controls, Device Design, Nonconforming Materials.   🔹 Advanced Manufacturing Clearinghouse: Grants available for new technology!   🔹 Advancing Health Equity: Bridging gaps in primary care deserts with technology and home-based healthcare.   Jeff's passion for patient care and medical device innovation was clear.   Stay tuned for more MedCon insights and reviews!   Questions or need help with QMSR, Recall Remediations, or other consulting needs? DM me or email at Gregory.austin@eci-rx.com   #MedCon2024 #FDA #MedicalDevices #Innovation #Healthcare #CDRH

Welcome Guido Rodrigo Mora, Project Manager, to ECI!🎉 Guido is an expert in medical device transfers, validation and new product introduction with over 21 years of experience. Guido decided to join ECI because "this was a great opportunity to consult with clients and join an incredible team and organization where I can continue to grow." We could not agree more. We're so glad Guido joined our team to help further our mission of being a global leader of professional consulting services and shared business process solutions for the life sciences industry. Interested in working for a mission-driven company? Take a look at our current job openings here: https://lnkd.in/exnUhbcC #ECI #LifeSciencesConsulting #WeAreHiring