A Publication for the Practising Medical Specialist, Industry Executive & Investor

Medical Device News Magazine is a digital Publication Founded in 2008, and proudly located in the United States

Medical Device News Magazine delivers the latest updates from the medical device and biotechnology sectors. We take pride in offering high-quality, in-depth content, crafted by a team of experienced professionals. Our goal is to provide a unique perspective on the trends and innovations driving the future of medical technology. By reading our articles, you’re not only gaining exclusive industry insights but also becoming part of a community committed to advancing healthcare through groundbreaking technologies. Explore our content and consider partnering with us for advertising opportunities!

Medical Device Industry News: Latest Developments, Breakthroughs, and Future Outlook

Paragonix Technologies Secures Official EU MDR Approval for 5 Organ Preservation Devices

Dr. Lisa Anderson, President of Paragonix Technologies. “This achievement validates our technology’s safety and effectiveness while expanding our ability to serve patients and healthcare providers in critical transplant care across the world. With this approval and the support structure provided by Sweden-based Getinge, we are dedicated to setting new standards in organ preservation, advancing the future of transplantation, and making a global impact.”

Clinical Trials

Updated Phase 2 CAPTIVATE Study Results

“After more than five years, the CAPTIVATE study findings confirm the sustained benefit of the fixed duration combination of ibrutinib and venetoclax as a first-line treatment for patients living with CLL, including in those with higher risk genomic features,” said Paolo Ghia MD, Università Vita-Salute San Raffaele and IRCCS Ospedale San Raffaele, Milan, Italy, study investigator.‡ “This all-oral, chemotherapy-free, fixed-duration regimen offers eligible patients the advantage of an extended, treatment-free interval while effectively keeping their disease under control.”

Editas Medicine Reports New Safety and Efficacy Data from the RUBY Trial of Reni-cel in 18 Patients with Sickle Cell Disease | Presented at the European Hematology Association (EHA) Annual Congress

“These data confirm the observations from our prior clinical readouts and further support our belief that reni-cel has the potential to be a best-in-class and clinically differentiated, one-time, durable medicine that can provide life-changing clinical benefits to patients,” said Baisong Mei, M.D., Ph.D., Chief Medical Officer, Editas Medicine.

Innovent Biologics Delivers Oral Presentation on Clinical Data of IBI363 (First-in-class PD-1/IL-2α-bias Bispecific Antibody Fusion Protein) in Advanced Non-small Cell Lung Cancer and Other Solid Tumors at the 2024 ESMO Virtual Plenary

Dr. Hui Zhou, Senior Vice President of Innovent, stated: “IBI363, as a first-in-class molecule, represents Innovent’s continuous innovation and advancement in the immunotherapy field. Starting from molecular design, the unique approach of α bias with β and γ attenuated were creatively adopted, which greatly improved the therapeutic window of IL-2. Meanwhile, through the specific traction of PD-1, tumor-specific T cells expressing both PD-1 and CD25 can be selectively stimulated and amplified, thus exerting anti-tumor effects. IBI363 has demonstrated excellent druggability with antibody-like pharmacokinetics (IgG-like PK) and low immunogenicity.

Biotechnology News

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

PCI Pharma Services Bedford

PCI Pharma Services In Bedford, New Hampshire Location Successfully Completes International Coalition of Medicines Regulatory Authorities Inspection

The new ICMRA program is designed to abbreviate the time necessary to receive regulatory approvals from multiple countries. Regulatory agencies from several countries can convene for one inspection as a team, allowing CDMOs such as PCI Pharma Services to attain approval from each of the participating ICMRA countries simultaneously rather than undergo separate, phased inspections.

Partillion Bioscience Announces Early Access Program for Nanovial Multicell Assays to Enable the Study of Cell-to-Cell Interactions

“Our Nanovial Multicell Assays are a game-changer, opening up new possibilities in research areas where the precise colocalization of cells is essential for studying complex cell-to-cell interactions or screening for therapeutic molecules released by one cell that act on another” said Joe de Rutte, Co-founder and CEO of Partillion. “By enabling these complex screens, all using standard life science instrumentation, we’re enabling scientists to scale studies of how cells interact with other cells, whether it’s better understanding tumors in the context of immune cells in their microenvironment, host-pathogen interactions or developing the next-generation therapies.”

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FDA Medical Device Updates

Comprehensive Insights into Medical Device & Biotechnology Company Mergers, Acquisitions & Funding

Kazia Therapeutics Announces $2 Million Registered Direct Offering

Kazia has also agreed to issue in a concurrent private placement unregistered warrants to purchase up to an aggregate of 4,444,445 ADSs. The warrants will have an exercise price of $0.583 per ADS, will be immediately exercisable upon issuance, and will expire five and one-half years from the date of issuance. The closing of the offering is expected to occur on or about December 5, 2023, subject to the satisfaction of customary closing conditions.

Market Reports

Advancements in Imaging

Philips and Masimo

Jun 01, 2023 Philips and Masimo Introduce New, Advanced Monitoring Capabilities to Philips High Acuity Patient Monitors

“Combining our expertise in noninvasive monitoring and signal processing technologies with Philips’ expertise in integrated patient monitoring and therapy solutions is a win-win for patients and clinicians alike,” said Jon Coleman, President of Worldwide OEM Sales and Global Health, Masimo. “We are proud that Philips has chosen to make our innovative SedLine, O3, and NomoLine technologies available to their customers. We look forward to continuing our partnership with a focus on improving patient outcomes and reducing the cost of care.”

CT System

AI-powered CT System Launches Reports Philips

Philips CT 3500, is a new high-throughput CT system targeting the needs of routine radiology and high-volume screening programs. Powered by AI, the Philips CT 3500 includes a range of image-reconstruction and workflow-enhancing features that help to deliver the consistency, speed, and first-time-right image quality needed for confident diagnoses by clinicians and increased return on investment – even in the most demanding, high-volume care settings. 

Hospitals In the News

Medical Device and Biotechnology Executives: Innovative Professionals on the Move and Making Waves in the Industry

Non-Profit News

Healthcare - Understanding the Business Side of the Industry and Its Implications

Healthcare Careers

Nurses Corner

6 Questions to Ask Your Recruitment Agency

6 Questions to Ask Your Recruitment Agency

A recruitment agency can be a valuable resource for companies looking to hire new employees. However, employers must understand how these agencies work and what

9 Tips For Critical Care Nurses

9 Tips For Critical Care Nurses

Nurses today are worried about being overworked, understaffed, and seriously exhausted. Among many nursing vocations, critical care nurses have more duties than traditional RNs. Experts

Health: A Comprehensive Exploration of Wellness, Nutrition, and Overall Well-Being for a Healthier Life

Articles Designed to Inspire and Guide You Toward Achieving Excellence and Success in All Your Endeavors.