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⌚ US FDA approves Masimo W1 medical watch integration with SafetyNet The FDA approval allows the medical watch to be integrated with the Masimo SafetyNet comprehensive telemonitoring solution. Last year, the US FDA approved Masimo W1 Medical to provide continuous oxygen saturation (SpO2) and pulse rate (PR) for use at home and in hospitals. Masimo said that the integration of W1 medical watch and SafetyNet telemonitoring solution enables accurate and reliable patient data, collected conveniently from the wrist. Read more online: https://lnkd.in/eaH8EJGF 📰 Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter #MedicalDeviceDevelopments #medicaldevices #medicalmanufacturing

💓 Clario secures FDA approval for SpiroSphere system with wireless ECG The system is designed to run with the COR-12, a compact and wireless ECG device that transmits 12-channel ECG data via Bluetooth. SpiroSphere enables consecutive collection of spirometry and ECG data during a single site visit, using the company’s SpiroSphere platform. It consolidates all data into a single, unified database, simplifying the clinical trial process and eliminating the need for separate ECG devices or multiple databases for a study. Read more online: https://lnkd.in/e6Y4hgK5 📰 Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter #MedicalDeviceDevelopments #medicaldevices #medicalmanufacturing

On July 10th, China's National Medical Products Administration held a crucial regulatory meeting with technical experts, provincial authorities, and registrants to advance the oversight of innovative medical devices. This session specifically focused on: - The first domestic magnetic resonance imaging (MRI) system for pulmonary gas imaging. - The first Chinese-made variable-angle, dual-head, general-purpose SPECT-CT system. - Intracranial aneurysm CT angiography image-assisted detection software. Incorporating comprehensive inspection, evaluation, review, and monitoring data, the NMPA discussed key regulatory focuses and quality management essentials for registrants. With a commitment to high-quality innovation, the NMPA has approved 278 innovative medical device products to date. Moving forward, the NMPA will continue to ensure rigorous quality control throughout the entire lifecycle of these devices. This includes guiding registrants to fully implement their quality and safety responsibilities, thereby ensuring product safety and better meeting public healthcare needs. #Innovation #MedicalDevices #Regulation #NMPA #Healthcare

Discover the Future of Sterilization at MD&M West 2024! In just a couple of weeks, the MD&M West conference will be in full swing, and we've got something special lined up that you won't want to miss. Join us for an exclusive Tech Talk on "Working With Your Manufacturing Partner to Optimize Your EO (Ethylene Oxide) Sterilization Cycle" Discover the secrets to optimizing your Ethylene Oxide (EO) sterilization cycle in this engaging session. Relevant to all medical device companies with sterile units, this talk delves into crucial techniques to enhance your Ethylene Oxide (EO) sterilization processes: 1. Minimize EO Concentration 2. Shorten the Overall EO Sterilization Cycle Duration 3. Streamline Aeration Times for EO Sterilization 4. Expedite Wait Times for EO Biological Indicators (BIs) and BI Results This invaluable session is scheduled for Wednesday, February 7th, from 11:00 am to 12:00 pm in Meeting Room 210D. Whether you're new to Ethylene Oxide (EO) sterilization or a seasoned pro, this talk will offer powerful insights for everyone. Reserve your seat at this Tech Talk HERE: https://lnkd.in/ghFgTS3A Our presenters, Brandon Tillman and Dan Floyd, bring a wealth of experience to the table. Brandon Tillman, MBA RM(NRCM), Managing Director of ATL Technology's Point of Care business, boasts 22+ years in the industry, guiding global medical device companies from ideation to seamless manufacturing of comprehensive medical solutions. His focus at ATL is on creating comprehensive patient monitoring and wearable medical solutions. Dan Floyd, the MDM & Regulatory Specialist at Tyvek Healthcare, is a registered microbiologist with over 32 years of experience. As an AAMI Certified Industrial Sterilization Specialist, Dan's expertise spans EO, VHP, radiation, dry heat, moist heat, ozone, liquid chemical sterilization testing, and microbiology testing requirements for medical devices. #MDMWest #Sterilization #MedicalDevices #TechTalk #EngineeringExcellence #MDM2024

Exciting news in the medical device industry! The MDCG has just published the NB capacity dashboard which includes the results of surveys completed by NB over the past year. This is a great resource for anyone interested in understanding NB capacity in Europe. The European Commission’s Directorate-General for Health and Food Safety (DG SANTE) - through the European Health and Digital Executive Agency (HaDEA) - has commissioned a “Study supporting the monitoring of availability of medical devices on the EU market”. The study started in December 2022 and will be running for 36 months (December 2025). The study has been contracted to a consortium led by the Austrian National Public Health Institute (Gesundheit Österreich GmbH/GÖG), in collaboration with Areté and Civic Consulting. In the context of the study, a dashboard has been developed. The dashboard presents an overview of the data gathered from different stakeholders. In addition, comparable data from previous surveys of notified bodies conducted by the European Commission have been integrated in the dashboard. Check out the dashboard at the following link: https://lnkd.in/dFSUSAFt #MDCG #medicaldevice #NBcapacity #Europe

In accordance with the WHA75(25) decision on nomenclature of medical devices, WHO convenes this webinar to present the inclusion of EMDN and GMDN nomenclature systems in WHO platforms including MeDevIS. Register here : https://lnkd.in/gTE5Viit

Let’s talk about stability studies! Stability studies for medical devices are commonly carried out by manufacturers while the regulatory and normative framework is not always straightforward. The objective of this webinar is to provide general recommendations for the implementation of a study design according to the context. Furthermore, recent experiences, challenges and pitfalls will be shared and discussed. Register here and join us 👉 https://lnkd.in/dxGfkdqY #MedicalDeviceTesting #StabilityStudies #SupportManufacturers #TestingForLife #Eurofins #MeetTheExpert #LetsTalkAboutRegulatoryStuff

🔊 The second MDCG Guidance of the year was released   The Medical Device Coordination Group (MDCG) just published the second guidance of the year. MDCG 2024-02, on the procedures for the updates of the European Medical Device Nomenclature (EMDN). 🏥   This guidance explains how the nomenclature will be annually reviewed and updated based on the EMDN use and related users’ feedback.   🔗 Have a look at our latest article on the topic -> https://lnkd.in/eFPEsUs4 #medicaldevices #guidance #news

Growth and Dynamics of the Global Medical Suction Devices Market The global market for medical suction devices has shown robust growth, driven by increasing healthcare needs and technological advancements. Valued at $730.7 million in 2021, this market is projected to reach $1,391.1 million by 2031, growing at a compound annual growth rate (CAGR) of 6.8% from 2022 to 2031. Medical suction devices play a crucial role in emergency and clinical settings, aiding in the removal of bodily fluids and secretions from patients who cannot clear them independently. 𝐆𝐞𝐭 𝐚 𝐒𝐚𝐦𝐩𝐥𝐞 𝐂𝐨𝐩𝐲 𝐨𝐟 𝐭𝐡𝐢𝐬 𝐑𝐞𝐩𝐨𝐫𝐭: https://lnkd.in/g42dk-7f

Different systems and technologies in #hospitals create #data silos that urgently need to be broken down. The Medical Device Information Platform (#MDIP) can provide an IHE-based remedy here and this relieve the burden on medical #professional staff. Capsule MDIP is a unified solution for data integration and sharing from over 1,000 medical devices. Come and meet Christiane Clauss and Omar Mamsa to find out more at #DIVI23 (November 29 - December 1st) Booth F 3-08. #DACHpost #MDIP #DIVI #Clinicaldata