Medical Device News

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Medical Device News Magazine Notes:

In the rapidly evolving landscape of healthcare, staying informed about the latest advancements in medical technology is essential for professionals and enthusiasts alike. Medical Device News Magazine serves as a vital resource, offering insights into cutting-edge innovations, regulatory developments, and industry trends that impact both patient care and business strategies. This publication aims to bridge the gap between healthcare professionals, investors, and the medical device industry, providing a comprehensive platform of news that can result in discussions on medical device/biotechnology advancements and their implications for the future of medicine.

Read on as we explore the intersection of technology and healthcare, facilitating informed decision-making and fostering collaboration within this dynamic field. Inquire about advertising. Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc.

Industry Expert Byline

Harnessing the Power of the Heart and Mind: Overcoming Atrial Fibrillation and Launching a Business | By Jim Kaveney

Jim Kaveney writes: "In both entrepreneurship and managing AFib, I have learned that the heart and mind are not in opposition but work together in powerful harmony. Whether navigating the unpredictable rhythms of my heart or the rollercoaster ride of building a business, I discovered that resilience is born from this partnership. By harnessing the power of both, I transformed my pain into purpose, allowing me to overcome the challenges of AFib and entrepreneurship, and ultimately, to help others do the same."

Voluntary Recall Notifying Medtronic Insulin Pump Users of Potential Risks of Shortened Pump Battery Life

Medtronic plc voluntarily issued a field action starting on July 31, 2024, notifying global customers of its MiniMed™ 600 series or 700 series insulin pumps to follow their pump's built-in alerts and alarms for battery status and to contact Medtronic if they observe changes in the battery life of their pump

OrganOx metra® System Approved for Liver Transplantation in Canada

The OrganOx metra® System utilizes normothermic machine perfusion, or NMP, to circulate oxygenated blood, medications, and nutrients to donated organs at normal body temperature and near physiological conditions.

Mergers & Acquisitions & Funding

Syncona: Resolution Therapeutics Raises £63.5 Million in Series B Financing | Appoints New Chair

Use of proceeds from the Series B financing will support the clinical entry and development of RTX001, with a Phase I/II trial expected to start in Q4 CY2024. Following this financing, Resolution Therapeutics is funded to deliver data from this trial, anticipated in CY2026, a key value inflection point with the potential to drive significant NAV growth for Syncona. Proceeds will also be used to develop the company’s manufacturing platform, expand the pre-clinical pipeline, and further strengthen the management team, following several key recent appointments, including Dr Amir Hefni as CEO, Simon Ramsden as CFO and Dr Clifford A. Brass as CMO.

Celaid Therapeutics Inc. Secures up to $19M Grant from the Japanese Agency for Medical Research and Development

Celaid Therapeutics secures up to approx. $19M non-dilutive grant funding from Japanese government. The grant funding will support the development of Celaid's hematopoietic stem cell product for pediatric non-malignant diseases.

Clinical Trials & Updates

Conformal Medical Announces Launch of the GLACE Study with Next-Gen CLAAS® AcuFORM™ Left Atrial Appendage Occlusion Device

"The use of ICE imaging in LAAO is growing significantly and will continue," said James Reinstein, President and CEO of Conformal Medical. "Our next-generation LAAO technology conforms to individual anatomies, enabling clinicians to simplify the procedure with 2 sizes, the ability to confirm seal, and eliminate general anesthesia & intubation."

Aethlon Medical Receives Ethics Committee Approval for Hemopurifier® Cancer Trial in India

"The approval from the MIEC, coming closely on the heels of our two ethics committee approvals in Australia, to conduct this early feasibility study, is another important step in our plan to evaluate use of the Hemopurifier as a treatment option in multiple tumor types, where cancer associated exosomes may promote immune suppression and metastasis," stated Steven LaRosa, MD, Chief Medical Officer of Aethlon Medical.

Biotechnology News

New Project Will Enable Rapid Detection of Staphylococcus Bacteria & Create a New Bio-based Disinfectant to Reduce Hospital-acquired Infections

Early detection of nosocomial infections and effective disinfection of hospitals and healthcare centres are key to reducing these figures, but the methods currently used have their limitations. Hence the creation of the NOSOSENS Project, which is working on a new bio-based disinfectant designed to eliminate the main pathogens on a new, flexible and portable biosensor platform. It uses printed electrochemical sensors for rapid, selective detection of Staphylococcus aureus, which is resistant to methicillin and responsible for 11% of nosocomial infections.

At Pack Expo, Schreiner MediPharm Will Showcase New RFID Labels with Digital Seal Function

Also at Pack Expo, Schreiner MediPharm will highlight recently introduced label solutions for applications with sensitive APIs, as well as its latest sustainability-minded product solutions.

Headlines

Pioneering Hospitals Take Major Steps Towards Decarbonizing Healthcare with Philips

“Good healthcare has to be environmentally sustainable, which means words and good intentions urgently need to be turned into positive actions. Philips is committed to co-creating solutions that drive measurable, impactful change. By working with like-minded action leaders around the world, sharing with them our expertise in sustainable healthcare operations, we are helping them to take critical and tangible steps toward a greener future, while at the same time enhancing patient care,” said Robert Metzke, Global Head of Sustainability at Philips.

IVUS and iFR Technologies Receive Top-level Recognition in New ESC Guidelines, Reinforcing their Role In Optimizing Coronary Interventions and Patient Outcomes

The latest updates to these ESC guidelines emphasize the robust clinical evidence supporting the use of intravascular ultrasound (IVUS) and instantaneous wave-free ratio (iFR), both of which have demonstrated significant benefits in improving patient outcomes through numerous large-scale randomized trials like DEFINE FLAIR and iFR SWEDEHEART. The updates were announced at the recent ESC Congress in London, five years after the last update in 2019, and simultaneously published in the European Heart Journal.

Market Reports

Hospitals In the News

Delray Medical Center is First Hospital in South Florida to Enroll a Patient in PICASSO Trial

Delray Medical is the first hospital in South Florida to enroll a patient in the PICASSO trial.  The trial, which is in the critical third phase, is aimed at improving management for patients with tandem occlusions. This achievement is thanks to interventional neurologists Drs. Nils Mueller-Kronast and Dennys Reyes at Delray Medical Center, who are committed to improving stroke care through innovative research.

Executives Making Headlines

Dr. John Beeler is a seasoned biopharma executive with extensive experience in growing innovative companies, will lead BPGbio’s business development team in securing licensing and commercial partnership opportunities for BPGbio’s NAi Interrogative Biology platform and its extensive pipeline of AI-developed therapeutic candidates.
Christopher Whitmore is a highly accomplished executive who brings over 20 years of strategic finance, accounting, and operational expertise. His deep experience spans from early-stage biotech to publicly-traded companies, with a focus on both private and public capital raising.
With over 27 years of experience in the pharmaceutical industry, Andy Fuller brings extensive expertise in developing and executing go-to-market and payer engagement strategies across highly competitive markets.
A practicing urologic surgeon who has performed more than 5,000 robotic-assisted procedures, Dr James Porter is a recognized leader among the global surgical community and one of the top five robotic surgery practitioners in the U.S. 
Luba Greenwood is a distinguished executive and investor with over 20 years’ experience in healthcare and tech. She has led over $10 billion USD in deals and investment over multiple therapeutic areas, leading success and scaling companies across the life sciences, medical devices, diagnostics, and tech sectors, including co-founding biotech and digital companies in the immunotherapy, women’s health, AI/ML and microbiome space.

FDA

Somite Therapeutics Announces FDA Orphan Drug and Rare Pediatric Disease Designations for SMT-M01 in Duchenne Muscular Dystrophy

"Receiving both Orphan Drug and Rare Pediatric Disease Designations for SMT-M01 is a significant milestone for Somite Therapeutics and, more importantly, for patients suffering from Duchenne muscular dystrophy," said Dr. Micha Breakstone, Founder and CEO of Somite Therapeutics. "These designations underscore the critical unmet need in DMD and the potential of our AI-driven approach to develop innovative cell therapies. We are committed to advancing SMT-M01 through clinical development as rapidly as possible to make a meaningful difference for DMD patients and their families."

Non Profit News

At Pack Expo, Schreiner MediPharm Will Showcase New RFID Labels with Digital Seal Function

Also at Pack Expo, Schreiner MediPharm will highlight recently introduced label solutions for applications with sensitive APIs, as well as its latest sustainability-minded product solutions.

OrganOx metra® System Approved for Liver Transplantation in Canada

The OrganOx metra® System utilizes normothermic machine perfusion, or NMP, to circulate oxygenated blood, medications, and nutrients to donated organs at normal body temperature and near physiological conditions.

Celaid Therapeutics Inc. Secures up to $19M Grant from the Japanese Agency for Medical Research and Development

Celaid Therapeutics secures up to approx. $19M non-dilutive grant funding from Japanese government. The grant funding will support the development of Celaid's hematopoietic stem cell product for pediatric non-malignant diseases.

Yourgene Health and Genetix Launch First Local Non-invasive Prenatal Testing Service in Colombia

Lyn Rees, Executive Director, Yourgene Health, said: “We are thrilled to support Genetix by enabling them to deliver an advanced prenatal screening solution locally to the pregnant mothers in Colombia. We look forward to a long and fruitful relationship with their pioneering team.

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Non-Profit Updates

Nurses Corner

Hospice Nurse with 3 Million Social Media Followers Partners with Medical Device Company

Hospice Nurse Julie and Hospi Corporation Team Up to Raise Awareness about the Macy Catheter

Nurse.com Unveils Next-Generation Talent Marketplace To Revolutionize Healthcare Hiring

With a deep understanding of nurses’ behavior and skills, Nurse.com utilizes next-generation technology, candidate data, and completed courses to deliver personalized job matches. This approach enables recruiters to find candidates who not only meet their organization’s needs but also fit its culture.
Renowned Vascular Surgeon Dr Frank Veith Unveils Dark Side Of The Medical Profession In Revealing New Memoir

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