Medical Device News
Saturday, September 7, 2024

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Medical Device News Magazine advises......

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.

The Perils of Over-Regulating AI in Healthcare and Life Sciences | By Adnan Masood, PhD. Chief AI Architect

Medical Device News Magazine -
As an AI researcher and practitioner deeply embedded in the healthcare and life sciences sectors, Dr. Masood sees the passage of California's SB 1047 as a complex issue with significant implications. He writes this controversial bill, now heading to Governor Newsom’s desk, represents a fundamental misunderstanding of AI as a general-purpose technology. It attempts to regulate the technology itself rather than focusing on specific, problematic applications.
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RefleXion Announces World’s First Single-Plan Multi-Modality Radiotherapy to Patient with Stage 4 Cancer at Yale New Haven Health

"By integrating different treatment modalities within the same plan, we can tailor the optimal treatment approach to each tumor,” said Henry S. Park, M.D., M.P.H., chief, Biology-guided Radiotherapy Program, Therapeutic Radiology at Yale School of Medicine. “In this patient, SCINTIX therapy treated the moving lung tumor, while SBRT targeted a static tumor elsewhere.

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.

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.”

Medicus IT Announces Supplier Agreement with EyeProGPO to Enhance Services Reach

Through this partnership, Medicus IT, already a leader in the ophthalmology space and renowned for aiding ophthalmology practices nationwide with cutting-edge technology tailored to the needs of providers, patients, and staff, will expand its reach to over 1100 members of EyeProGPO. This expansion further solidifies Medicus' position as the premier IT solutions provider dedicated to healthcare and the unique complexities of maintaining secure IT environments.

Mergers & Acquisitions & Funding

CytoTronics Secures $13.5M Series Seed 2 Financing to Speed Market Entry of Pixel System for Breakthroughs in Cell Biology

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The additional capital enables CytoTronics to build off a successful early access program and accelerate market entry of their semiconductor-to-live-cell interface for cell biology applications, Pixel™.

Acquisition of Critical Care from Edwards Lifescience Completed | Reports BD

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"The health care industry is being redefined by AI, robotics, and autonomous solutions, and our team continues to accelerate the application of these new technologies to improve the quality and cost of patient care around the world," said Tom Polen, chairman, chief executive officer and president of BD. "Today, BD is proud to welcome BD Advanced Patient Monitoring, whose leading technologies, AI-enabled solutions and strong innovation pipeline expand our portfolio of smart, connected care solutions, create significant value for customers, and put BD at the forefront of enabling the future of health care."

PaceMate Acquires Medtronic Paceart Optima™ System, Bringing Complementary Capabilities to Cardiac Data Management

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“After a comprehensive evaluation, we are confident PaceMate is the best organization to service Paceart customers and their future cardiac data workflow needs,” said Kweli P. Thompson, M.D., M.P.H., senior vice president and president, Medtronic Cardiac Rhythm Management. “PaceMate offers best-in-class cardiac data management solutions and will provide excellent ongoing support to Paceart customers.”

XII Medical Raises $45 Mil in Series B Financing

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To advance best-in-class neuromodulation therapy for obstructive sleep apnea.

Clinical Trials & Updates

Delcath Systems Reports Positive Outcomes from Independent Study on Hepatic Perfusion for Uveal Melanoma Patients

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The 30-patient study reported that the Delcath Systems HEPZATO KIT™ (melphalan/Hepatic Delivery System (HDS)) provided better disease control in the liver and improved progression-free survival in patients with hepatic metastases from uveal melanoma, compared to both immunotherapy and other liver-directed therapies.

Lucid Diagnostics Announces Publication of Analytical Validation Study of EsoGuard® for Early Detection of Esophageal Precancer and Cancer

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"This analytical validation study strongly complements EsoGuard's extensive peer-reviewed, published clinical validity and clinical utility evidence base," said Suman Verma, M.D., PhD, Chief Scientific Officer at Lucid Diagnostics. "The results demonstrate very robust analytical performance of the EsoGuard assay performed in our CLIA-certified, CAP-accredited, NY State-approved commercial laboratory."

Jupiter Endovascular Exits Stealth With $21M in New Financing to Fund Pivotal Trial for Pulmonary Embolism

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The funding will be used to support Jupiter Endovascular in their upcoming pivotal trial for Pulmonary Embolism and development of additional clinical applications of the Endoportal ControlTM technology.

osteolabs Publishes First Real-World Evidence Data from Close to 3, 000 OsteoTest Patient Samples

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“We are very excited about the results from this collaborative effort that have now culminated in a publication in Bone, “ said Prof. Anton Eisenhauer who is a key inventor of the CIM technology and osteolabs´ Chief Scientific Officer. “This larger subset of routine clinical samples fully supports the potential for OsteoTest to qualify as a new universal diagnostic method for early osteoporosis risk assessment and therapeutic control.”

Genprex Announces Positive Clinical Study Updates from Acclaim-1 and Acclaim-3 Phase 1/2 Clinical Trials in Lung Cancer

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Genprex notes the patients in the Company's lung cancer clinical trials are being treated with the Company's lead drug candidate, Reqorsa® (quaratusugene ozeplasmid) Gene Therapy. Two patients in the Acclaim-1 study have had prolonged Progression Free Survival (PFS) and importantly, the first treated patient in the Acclaim-3 study attained a Partial Remission (PR) from the start of maintenance therapy.
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Biotechnology News

AliveDx Receives IVDR-CE Mark for Multiplexed Assay to Accurately Detect Celiac Disease on the MosaiQ® System

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"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." 

PHC Unveils Prototype of LiCellGrow, New Cell Expansion System to Support Development of Cell and Gene Therapy Products Manufacturing Process

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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.

WuXi Biologics Successfully Completes First Scale-Up of High-Productivity Bioprocessing Platform WuXiUI™ in 2,000L GMP Manufacturing

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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
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Headlines

MAUI Imaging Emerges From Stealth With $4 Million Department of Defense Contract To Support Trauma Medicine

Medical Device News Magazine -
MAUI Imaging CEO and co-founder David Specht. “The feedback we have received from physicians and technologists highlights the profound need for a new ultrasound-based technology that enables imaging of all types of tissues. That need is most pronounced in trauma medicine, which is a major focus of MAUI’s collaborative development efforts.  Going forward, MAUI will be able to supply the volumetric imaging data for AI tools that predominantly come from CT and MRI.”

Life Molecular Imaging and PharmaLogic announce Neuraceq® availability in Denver

Medical Device News Magazine -
"By partnering with PharmaLogic and offering Neuraceq® in Denver, Life Molecular Imaging is excited to expand access of Neuraceq® for the detection of beta-amyloid plaques in the brain. We believe this additional access benefits physicians and patients, as well as our pharma partners for routine clinical and research use. We are excited to collaborate with Pharmalogic today and look forward to more opportunities in the future. " said Ludger Dinkelborg, Ph.D., Managing Director at LMI.
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Market Reports

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Hospitals In the News

Kidney Donors | Risk of Death at All-Time Low

Medical Device News Magazine -
The results further showed that while their overall risk remained small, kidney donors who were male and those with a history of high blood pressure were more likely to die within 90 days of surgery than other donors. Meanwhile, age, race, and ethnicity had no bearing on mortality.
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Executives Making Headlines

Chad Hoskins Appointed CEO at Phagenesis | Following Recent Close of $42M Series D Financing

EXECUTIVES0
Chad Hoskins brings more than two decades of experience launching innovative medical technologies. Most recently, he served as CEO of Axon Therapies, developing a novel denervation technology to treat heart failure.

CMR Surgical Bolsters Leadership Team

EXECUTIVES0
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.

Crossject Appoints Tony Tipton as U.S. Chief Operating Officer in Preparation for Commercialization of ZEPIZURE® Epilepsy Rescue Treatment

EXECUTIVES0
Tony Tipton has over 25 years of experience across the key pillars of commercial pharmaceuticals business, encompassing corporate leadership, business development, market access, sales force leadership, marketing and trade operations.

Dr Kali Stasi Appointed Chief Medical Officer at SalioGen Therapeutics

EXECUTIVES0
Most recently, Dr Kali Stasi served as Senior Vice President of Clinical Development at Adverum Biotechnologies.

Lloyd Diamond | Appointed Chief Executive Officer at Nitinotes

EXECUTIVES0
Lloyd Diamond brings more than 30 years of leadership in the medical device industry, having spearheaded significant advancements in orthopedics, endoscopic, and general surgical devices. Most recently, he served as CEO of Pixium Vision S.A., where he led the development of groundbreaking bionic vision systems and strategic partnerships.

FDA

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

SKG1108 is a recombinant adeno-associated virus (rAAV) vector with innovative design, utilizing the novel intravitreal capsid AAV.0106 to deliver single-stranded DNA encoding light-activatable proteins directly to the retina. The protein, regulated by specific genetic elements, aims to improve or restore visual function by generating new photo-sensing cells, thereby compensating for the loss of rod and cone photoreceptors in patients with late-stage RP, agnostic on the specific gene or genetic mutation responsible for the condition.

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

Qure.ai Launches FDA-cleared AI Solution for Advanced Lung Nodule Quantification on CT Scans at AABIP 2024

GrayMatters Health Expands Veteran and Civilian Access to FDA-Cleared Prism for PTSD™ Treatment

Non Profit News

The Perils of Over-Regulating AI in Healthcare and Life Sciences | By Adnan Masood, PhD. Chief AI Architect

0
As an AI researcher and practitioner deeply embedded in the healthcare and life sciences sectors, Dr. Masood sees the passage of California's SB 1047 as a complex issue with significant implications. He writes this controversial bill, now heading to Governor Newsom’s desk, represents a fundamental misunderstanding of AI as a general-purpose technology. It attempts to regulate the technology itself rather than focusing on specific, problematic applications.

Acquisition of Critical Care from Edwards Lifescience Completed | Reports BD

0
"The health care industry is being redefined by AI, robotics, and autonomous solutions, and our team continues to accelerate the application of these new technologies to improve the quality and cost of patient care around the world," said Tom Polen, chairman, chief executive officer and president of BD. "Today, BD is proud to welcome BD Advanced Patient Monitoring, whose leading technologies, AI-enabled solutions and strong innovation pipeline expand our portfolio of smart, connected care solutions, create significant value for customers, and put BD at the forefront of enabling the future of health care."

Vision-based ChatGPT Shows Deficits Interpreting Radiologic Images

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The study’s results were published today in Radiology, a journal of the Radiological Society of North America (RSNA).

AliveDx Receives IVDR-CE Mark for Multiplexed Assay to Accurately Detect Celiac Disease on the MosaiQ® System

0
"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." 

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Non-Profit Updates

Nurses Corner

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Archer Review Unveils Cutting-Edge Products Catering to Every Stage of the Nurse Life Cycle

"Our mission at Archer Review has always been to empower nursing students with the best tools and resources to succeed," said Morgan Taylor, DNP, CPNP-PC, CNO of Archer Review. "With the launch of these new products, we are extending our support to cover every stage of the nurse life cycle, from aspiring students to practicing professionals."
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University of Phoenix College of Nursing Dean Dr Raelene Brooks Featured Speaker at Healthcare in the Age of Personalization Summit

“Patients deserve personalized, empowered care by their healthcare providers,” states Dean Dr Raelene Brooks. “Healthcare providers are experts in their field and when committed to the very best patient care and experience, they can be powerful and collaborative advocates working alongside patients and other providers. I look forward to sharing insights from our own experience training and empowering our nursing students to also be patient advocates.”
Renowned Vascular Surgeon Dr Frank Veith Unveils Dark Side of the Medical Profession in Revealing New Memoir

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