Medical Device News Magazine

9/3/24: CMR Surgical Bolsters Leadership Team Markus Bauman has been appointed Chief Legal & Business Affairs Officer and will join the CMR Surgical executive leadership team and Michelle Paknad has been appointed Senior Vice President, Global Business Development, brings a wealth of commercial experience in the soft-tissue surgical robotics industry. More at https://lnkd.in/eRxh3wiT

9/3/24: SKG1108 Receives FDA Orphan Drug Designation for Retinitis Pigmentosa | Reports Skyline Therapeutics - This designation reflects the recognition by the FDA of the potential of SKG1108 for treating RP. The ODD grants special status to SKG1108 and qualifies it for various benefits, which will greatly accelerate the development of the drug and enhance patient access to the leading-edge therapeutic solution. More at https://lnkd.in/e6aY5bYi

9/3/24: AliveDx Receives IVDR-CE Mark for Multiplexed Assay to Accurately Detect Celiac Disease on the MosaiQ® System "We are thrilled to obtain the CE mark for our MosaiQ AiPlex CD microarray," said Manuel O. Mendez, CEO of AliveDx. "The MosaiQ fast portfolio expansion marks our fourth microarray CE mark approval in the last 12 months reflecting our dedication to rapidly advance diagnostic technologies and our commitment to support the millions of individuals affected by autoimmune diseases. Early and accurate diagnosis is crucial for managing this condition. Our innovative MosaiQ microarray solutions represent a significant advancement to partner with laboratorians and clinicians to reduce healthcare costs and improve patient outcomes and quality of life."  More on their news at https://lnkd.in/e7FeCqEC

9/3/24: Iridium Network Becomes 1st Center In the World to Use RayCare and TrueBeam to Treat a Patient: Dr. Piet Dirix, Radiation Oncologist, Iridium Network, says: “My team and I are extremely happy to have been part of the journey of developing RayCare to what it is today, a next generation oncology information system designed to incorporate all disciplines of cancer care. We aspire to create one oncology workflow, allowing a seamless experience for both patients and health care professionals.” More at https://lnkd.in/eZzAG9iJ

9/3/24: ProBiotix Health Strengthens Global Presence With DanCare Chinese Distribution Deal - This strategic move marks a significant step for ProBiotix Health in penetrating the Chinese health and nutrition market with cardiometabolic supplement solutions. The InstaMelt formulation, ProBiotix's newly developed food supplement, offers innovative features for health brands and retailers, and will be fully rebranded as a finished turn-key solution by DanCare. More on this at https://lnkd.in/eEthWjCG

9/3/24: Recor Medical Supports European Society of Cardiology’s Hypertension Guidelines - The company notes the new guidelines, "2024 ESC Guidelines for the management of elevated blood pressure and hypertension," have been published online and recommend the consideration of renal denervation (RDN) as a safe and effective treatment option for patients who have uncontrolled resistant hypertension or those that have uncontrolled hypertension with a higher risk of cardiovascular disease, who express a preference to undergo RDN. More at https://lnkd.in/enuaPwFk

8/30/24: PHC Unveils Prototype of LiCellGrow, New Cell Expansion System to Support Development of Cell and Gene Therapy Products Manufacturing Process - PHC Corporation Biomedical Division (Headquarters: Chiyoda-ku, Tokyo; President: Nobuaki Nakamura, hereinafter referred to as "Biomedical Division") will showcase a prototype of its new cell expansion system LiCellGrow at the ISCT (International Society for Cell & Gene Therapy) Europe 2024 Regional Meeting held in Gothenburg, Sweden on September 4-6. LiCellGrow, currently under development, is designed to allow pharmaceutical companies to visualize continuous metabolic changes in cells in real-time and adjust the cell culture automatically to optimize conditions for cell growth. The system seeks to expand availability of cell and gene therapy (CGT) products by accelerating the manufacturing of specific cells needed for these therapies. https://lnkd.in/g2yYdNUb

8/30/24: WuXi Biologics Successfully Completes First Scale-Up of High-Productivity Bioprocessing Platform WuXiUI™ in 2,000L GMP Manufacturing By leveraging its ultra-intensified fed-batch platform, WuXiUI™, WuXi Biologics has completed its first scale-up to 2,000L drug substance (DS) GMP manufacturing, achieving a 4-fold productivity improvement compared to the traditional fed-batch process. The competitive performance achieved through the utilization of both WuXiUI™ and the proprietary platform cell culture media MagniCHO™ led to significant reduction in overall DS manufacturing COGS The consistent performance of WuXiUI™ – from small scales to 2,000L GMP manufacturing – is a testament to the advancement of the technology as a mature and robust platform capable of significantly improving the cost-effectiveness of biologics production. https://lnkd.in/gYZ4fdW3

8/30/24: Advancing Fully Implanted Hearing Systems | By Brent Lucas, CEO of Envoy Medical - The company has taken a different approach with its fully implanted #hearingdevices, and it looks to turn the industry on its… ear. "Listen" to what Brent Lucas, CEO of the company has to say including why the company is passionate about helping people on their hearing health journey by creating solutions that will positively impact society. https://lnkd.in/gHsJAK2Z

FYI- https://lnkd.in/e23-E7pz