Medical Device News
Tuesday, October 15, 2024

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Medical Device News:

What are the future trends of medical devices?  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 medical device 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

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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."
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Medical Device News Updates

TriCelX, Inc. Announces Opening of Its Flagship Clinic at The Baylor Scott & White Sports Therapy & Research Center at The Star in Frisco,...

Jakes Jordaan, CEO at TriCelX: “With the guidance of our Military Advisory Board, which includes Gen. Lance L. Smith and Brigadier Gen. Mark T. Kimmitt, our team is developing a proprietary biological medical countermeasures cell processing platform -- to produce native, non-expanded biologics -- to help our warriors facing unique threats such as Acute Radiation Syndrome, Traumatic Brain Injury and battlefield wounds.”

Grand Pack Machinery Launches The Newest Pharmatical Filling Machine At ALLPACK INDONESIA EXPO

It took us five years to develop the filling machines. Only after dozens of prototype testing and modifications are we ready to debut them in this exhibition. With the features of cost-effectiveness and high filling accuracy, our innovations can meet the production needs of customers in the pharmaceutical and food industries. ” said Bruce Fu, CEO of Grand Pack Machinery.

Mergers & Acquisitions & Funding

ZOLL Announces Closing of Acquisition of Select Vyaire Ventilator Product Lines

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With the acquisition complete, ZOLL will immediately make available to customers the bellavista®, fabian®*, LTV®, and 3100 HFOV product lines alongside ZOLL’s other respiratory care offerings. For these acquired product lines, all ventilators and associated consumables, service parts, accessories, and service program offerings will continue to be sold where currently available. Existing Vyaire contact channels will remain available for use during a transition period. Customers can also contact ZOLL at ventsales@zoll.com.

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

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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.

Clinical Trials & Updates

Penumbra Announces Completion of THUNDER IDE Study Enrollment for Acute Ischemic Stroke

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The THUNDER IDE study is a multi-center, single-arm study evaluating patients with acute ischemic stroke secondary to intracranial large vessel occlusion (LVO) who are eligible for mechanical thrombectomy. The primary efficacy endpoint includes revascularization of the occluded target vessel at immediate post-procedure.

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

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"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."
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Biotechnology News

BD Announces New Robotics Solution to Automate, Standardize Single-Cell Research

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The automated solution from the BD and Hamilton collaboration standardizes traditionally manual processes and speeds the generation of material for genetic sequencing. The solution includes the newly released BD® OMICS-One XT WTA Assay and the Hamilton® Microlab™ NGS STAR automated liquid handling platform. Because the NGS STAR is already installed in many laboratories and facilities worldwide, more researchers, processing samples across an array of genomics applications, can easily integrate the new automation-ready BD® assay into existing workflows.

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

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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.
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Headlines

Pioneering Hospitals Take Major Steps Towards Decarbonizing Healthcare with Philips

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“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

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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.
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Market Reports

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Hospitals In the News

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

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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.
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Executives Making Headlines

Mark Gaffney Is Appointed CEO of Calluna Pharma | Mark Altmeyer as Independent Chair of the Board

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Mark Gaffney brings over 20 years of experience in corporate strategy, business development, and operations in both private and public biotechnology companies, and will lead the team that defines and executes on the corporate strategy, particularly as its lead program is on pace to complete its Phase 1 program later this year. 

John Beeler Appointed SVP of Business Development at BPGbio

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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 Appointed CFO at Ray Therapeutics

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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.

Andy Fuller Appointed VP of Market Access at AESAR

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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.

Medtronic Hires Dr James Porter, One of the Nation’s Top Surgeons as CMO

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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. 

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."

Withings Sleep Rx Receives FDA Clearance for the First Contactless Device to Aid in the Diagnosis of Sleep Apnea

SKG1108 Receives FDA Orphan Drug Designation for Retinitis Pigmentosa | Reports Skyline Therapeutics

FDA Approves Illumina Cancer Biomarker Test with 2 Companion Diagnostics to Rapidly Match Patients to Targeted Therapies

Non Profit News

Mark Gaffney Is Appointed CEO of Calluna Pharma | Mark Altmeyer as Independent Chair of the Board

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Mark Gaffney brings over 20 years of experience in corporate strategy, business development, and operations in both private and public biotechnology companies, and will lead the team that defines and executes on the corporate strategy, particularly as its lead program is on pace to complete its Phase 1 program later this year. 

Understanding The Risks of Dysphagia And Aspiration

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Dysphagia is the medical term for difficulty swallowing. This...

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

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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

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

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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.

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Non-Profit Updates

Nurses Corner

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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
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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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