Pacific BioLabs, Inc.’s Post

Good news for patients and the medtech industry: To ensure continued availability of devices and increase transparency, yesterday the EU Commission announced its legislative proposal for: 1️⃣ Further extension of the transition period for in vitro diagnostic medical devices (IVDs) to 2027 (high risk devices), and 2028 and 2029 for medium and lower risk devices respectively 2️⃣ Earlier mandatory use of some modules of the European database on medical devices (EUDAMED) 3️⃣ New obligation for manufacturers to give prior notice in case of disruption of supply of certain medical devices and IVDs Read the full text and supporting docs here: https://lnkd.in/dFd-87cD or go directly to the EU Fact Sheet for a quick overview 👇

📚 Digital Edition: Market Pathways January 2024 is now available • Market Pathways' editors highlight the major medtech policy issues and developments they'll be tracking in 2024 • Leaders of the public-private Medical Device Innovation Consortium (MDIC) discuss their current efforts to identify and address barriers to innovation throughout the medical device life cycle • And in Consultants Corner, Marina Daineko discusses the finer points involved in building risk-based biocompatibility plans. Get the edition here: https://bit.ly/3uJ1sPB #biocompatability #medicaldevices #medtechpolicy #medtech #medtechinnovation

MichBio 2024 Medical Device Summit is underway! Let’s meet and discuss how STERNE Silicone Performance | EXSTO Group can serve you! #MichBio #MedicalDeviceSummit #MedicalInnovation

Can you believe it's 2024? 😱 With a brand new year comes so many new innovations! What are your medical device innovation predictions for 2024? What do you think we'll see more of? Less of? What do you think should be the most important medical innovation category in 2024? Tell me what you are feeling below! 🤓 #GeniusShield #biomedicalresearch #medicalinnovation #biomedicalinnovation #changetheworld #biomedicalentrepreneur #womeninstem #medicaldevices #biomedicalinnovation #FDA #Femtech #medicaldeviceregulation #productdevelopment #womenentrepreneurs #medicaldevices #medicaldeviceinnovation #innovatormindset #biomedicalentrepreneur

Can you believe it's 2024? 😱 With a brand new year comes so many new innovations! What are your medical device innovation predictions for 2024? What do you think we'll see more of? Less of? What do you think should be the most important medical innovation category in 2024? Tell me what you are feeling below! 🤓 #GeniusShield #biomedicalresearch #medicalinnovation #biomedicalinnovation #changetheworld #biomedicalentrepreneur #womeninstem #medicaldevices #biomedicalinnovation #FDA #Femtech #medicaldeviceregulation #productdevelopment #womenentrepreneurs #medicaldevices #medicaldeviceinnovation #innovatormindset #biomedicalentrepreneur

Update for the MedTech Industry! The European Commission has released new Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746. 📜✨ This is a pivotal step in ensuring compliance and streamlining processes for all stakeholders in the diagnostics sector. Dive into the latest guidelines to stay ahead in the game and ensure your products meet the required standards. For more such updates visit omcmedical.com or contact us!! #MedTech #IVD #RegulationEU2017_746 #MedicalDevices #Compliance #HealthcareInnovation #EuropeanCommission #Diagnostics #QualityAssurance #RegulatoryAffairs #HealthcareRegulation #EURegulations #InVitroDiagnostics

The Medical Device and Diagnostic Innovation Cluster (MeDDIC), under the auspices of the South African Medical Research Council (SAMRC), is pleased to invite you to join us for the first Medical Devices Stakeholder Forum (MDSF) meeting for 2024. The MDSF is aimed at facilitating dialogue in the medical devices and diagnostics sector and will cover a wide range of topics ranging from Regulatory, Funding, Skills Development and Value chain(s). This is one of the tools we would like to re- introduce post the conclusion of the Medical Technology Masterplan to help achieve MeDDIC’s mission towards developing a vibrant, cohesive ecosystem in which stakeholders co-operate and collaborate to seamlessly design, develop, manufacture and commercialize medical devices with a significantly increased local content and thereby contributing to the sector and broader economic development.” The topics for the upcoming discussion will include but are not limited to challenges and opportunities in regulatory, reimbursement and procurement of medical devices and diagnostics. Please join us and share your experience and possible recommendations to help us build a more cohesive ecosystem. 

Registry-based studies are associated with a significant reduction in both cost and time. Download a recent industry study to see why leading medical device manufacturers are leveraging #rwd to accelerate innovation—https://lnkd.in/dhHS9eh2. #medicaldevicemanufacturing #rwe #clinicalregistry #medtech

interoperability is one of the most important properties of an information systems. Wemedoo AG had get it right.

Exciting News: Johnson & Johnson is in talks to acquire Shockwave Medical, a prominent cardiovascular device maker. This potential deal, anticipated to be finalized soon, emphasizes J&J's commitment to bolstering its medical-device division. Shockwave's market value surged from $11 billion to nearly $12 billion following the report, with its 2024 revenue projections showing a promising 27% increase from the previous year. Notably, J&J's recent $16.6 billion acquisition of Abiomed connects the companies, highlighting synergy in the sector. Joaquin Duato, J&J's CEO, aims for aggressive acquisitions in the medical-device sector, following a sales rebound post-pandemic. J&J is set to report its quarterly results on April 16. The uptick in healthcare M&A activities, up by 51% this year, reflects the industry's growth and resilience. Darin W. White