Saturday, September 23, 2023
Saturday, September 23, 2023

Medical Device News Magazine, is a digital publication founded in 2008 and located in the United States. Our publication is one of the most trusted sources of information for the medical device and biotech industries, providing timely and accurate updates to professionals and enthusiasts alike. With 24/7/365 accessibility, our magazine is the perfect solution for anyone looking for a fast, easy read on the latest industry news. Stay informed with Medical Device News Magazine – your one-stop source for biotech and medical device industry updates.

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Featured News

PADCEV® (enfortumab vedotin-ejfv) and KEYTRUDA® (pembrolizumab) Significantly Improve Overall Survival and Progression-Free Survival in Patients With Previously Untreated Advanced Bladder Cancer in Pivotal Phase...

The EV-302 study met its dual primary endpoints of overall survival (OS) and progression-free survival (PFS), compared to chemotherapy. An Independent Data Monitoring Committee determined that OS crossed the pre-specified efficacy boundary at interim analysis. The safety results of the combination are consistent with those of enfortumab vedotin in combination with pembrolizumab previously reported in cisplatin-ineligible patients with la/mUC.

NeuroBo Pharmaceuticals Doses First Patient in Its Phase 2a Clinical Trial Evaluating DA-1241 for the Treatment of NASH

"Dosing the first patient, on time, is a testament to our commitment to the clinical development of DA-1241 in patients with NASH," stated Hyung Heon Kim, President and Chief Executive Officer of NeuroBo. "Based on the pre-clinical and clinical evidence generated to date, DA-1241 has demonstrated reduced hepatic steatosis, hepatic inflammation, and liver fibrosis, while also improving glucose control, and was shown to be well tolerated in both healthy volunteers and in patients with type 2 diabetes mellitus (T2DM). Given this data, we believe that the mechanism of action of this promising cardiometabolic asset will translate into a safe and effective treatment for NASH, a disease with no current treatment options. The two-part design of this trial provides optionality for a potential interim analysis in the first half of 2024 and we expect to report the full data in the second half of 2024."

Medmain Inc. Has Been Selected for the U.S. Market Gateway Accelerator for BioSciences and MedTech

The "U.S. Market Gateway Accelerator for BioSciences and MedTech", sponsored by WorldUpstart, LLC, is an acceleration program that provides medical tech and life sciences startups with a proven track record outside the U.S. with the opportunity to enter and grow their business in the U.S. market.

Karger Publishers New Journal – Immune System

“Immune System is an innovative Open Access journal, welcoming articles with a broad background from basic science to clinical research, as long as the manuscript focuses on certain aspects of our immune response,” states editor-in-chief Désirée Larenas-Linnemann."

MindMed Completes Enrollment of Phase 2b Trial of MM-120 in Generalized Anxiety Disorder (GAD)

Robert Barrow, Chief Executive Officer and Director of MindMed. “Thanks in large part to the enthusiasm we have seen regarding MM-120 among investigators and patients, as well as the strong execution of our team, we were able to enroll almost 200 participants in this trial in just over a year. We anticipate sharing topline results during the fourth quarter of this year.”

Stryker’s Triathlon Tritanium Baseplate Marks a Decade of Positive Patient Impact

Marking its 10th anniversary, the Triathlon Tritanium baseplate is designed with Stryker Orthopaedic Modeling and Analytics (SOMA) and enabled by Stryker's proprietary additive manufacturing technology.

Medtronic Diabetes Announces CE Mark for New Simplera™ CGM with Disposable All-in-one Design

The company's newest Simplera™ CGM is 50% smaller than its previous generation with a simple insertion and improved user experience

Henkel Joins with MedTech Europe to Drive Innovation In the Medical Technology Industry

Henkel has a long history of supporting the medical technology industry with its advanced adhesive and surface solutions. Through this, Henkel and MedTech Europe will collaborate on various initiatives such as supporting research and development projects, driving thought leadership and engaging in industry forums.

AI Software Improves Endovascular Thrombectomy Treatment Times for Stroke Patients

The implementation of artificial intelligence-powered large vessel occlusion (LVO) detection software for acute stroke triage can improve endovascular thrombectomy treatment times, according to new research from UTHealth Houston.

Precision Dropper – The Next Revolution in Eye Health

Backed by a dedicated team and successful crowdfunding, Precision Dropper is rapidly transforming eye health across the world.

Clinical Trial Updates

Lipogems® Announces 140 Independent Peer Reviewed Publications with 5 Years of Follow up in Orthopaedics

Giorgio Ninzoli, President of Lipogems International. "The gold standard for evidence is 1 year follow up and we are excited to report 5 years follow up with positive results after a single injection of MicroFat."

Study Outcomes Could Provide Insights Into New Targeted Treatments to Manage this Challenging Disease

The study aims to determine if immediate biological preservation of patient-derived chordoma tumor tissue, collected intraoperatively and implanted for serial sampling in translational research, will provide new insights into the biological weakness of the disease and contribute to developing improved treatment therapies reports NICO.

Imaging /Ultrasound

Combining best-in-class AI-powered Technologies for Musculoskeletal (MSK) Imaging Workflows – ImageBiopsy Lab and Radiobotics sign Collaboration Agreement

Dr. Richard Ljuhar, CEO and Co-Founder of ImageBiopsy Lab, explains, "Before even considering the use of AI, it's crucial to grasp physicians' diagnostic workflow and needs. For this purpose we've closely collaborated with leading MSK radiologists, orthopaedics, and traumatologists over the past years. We're committed to revolutionizing the entire MSK diagnostic value chain for practitioners, patients, and healthcare systems.

Lunit’s AI-Powered Mammography Analysis Solution Achieves Comparable Diagnostic Performance with Human Readers

"This first study to apply the Personal Performance in Mammographic Screening (PERFORMS) scheme to AI algorithms marks a remarkable achievement, showcasing our AI's ability to match human performance in detecting breast cancer. It offers hope to patients worldwide and underscores AI's potential to enhance cancer detection and treatment outcomes," said Brandon Suh, CEO of Lunit.

Industry Executives Views & Opinions

The Hollywood Writers’ Strike and Ethical AI | By Ed Watal, Founder & Principal — Intellibus

Watal writes, "Less than 12 months ago, with the debut of AI-powered ChatGPT, the true power of AI hit the mainstream. Since then, it has established an unshakeable belief in everyone’s minds that artificial intelligence is here to stay and will forever alter a number of industries." What do you think? Read on.

Viraj Gandhi On Automation and Technology – to Drive Progress in Pharmaceutical Manufacturing

This article takes a closer look at the key benefits of automation and technology in pharmaceutical manufacturing and how Medivant Healthcare harnesses these solutions to drive progress across our production facilities. Read what Viraj Gandhi has to say.

Limb Loss and Preservation Registry (LLPR) Transforms Care Through Data and Insights | By Shawn Murphy, Vice President, Thought Leadership & Innovation Foundation (TLI)

Shawn Murphy writes, "The Limb Loss and Preservation Registry (LLPR) represents a pivotal development in patient care. It stands as the first collaborative database that unites hospital and health systems, provider organizations such as Accountable Care Organizations (ACOs), Integrated Delivery Networks (IDNs) and orthotic/prosthetic (O&P) practices, focusing on both upper and lower extremity acquired and congenital limb differences, as well as limb preservation populations. This collective effort has the potential to drive substantial advancements in patient outcomes, treatment effectiveness and care quality." Read to learn more.

It Takes an Ecosystem – Bringing Stakeholders Together is a Critical 1st Step to Solving Problems In Healthcare | By Andrew Cleeland, CEO, Fogarty Innovation

Andrew Cleeland writes, "Introducing a new medical therapy or technology is a complex, expensive, and time-consuming journey, one that is fraught with significant risk. While innovation often starts with a clear, well-defined unmet clinical need, it must be paired with an equally compelling value proposition. My mentor, Dr. Thomas Fogarty, once said, “An idea, by itself, has no importance whatsoever; it is the implementation of that idea and its acceptance by others that brings benefit to our patients.” Read on.

Chemotherapy Starts With Scalp Cooling Treatment: The Path to Improved Access | By Claire Paxman, Director of Global Training of Paxman

Paxman writes, "When Real Housewives of Miami star Guerdy Abraira recently proclaimed “Chemo Starts Now” after shaving off her hair before starting her treatment for breast cancer in People Magazine1, this made me realize just how little the general public and even celebrities like Abraria know about the medical technology being utilized today, such as scalp cooling systems, to manage and prevent chemotherapy-induced hair loss." Read to learn more.

The Evolution of Vascular Surgery in the Era of Artificial Intelligence “The Fifth Cardio-Vascular Revolution.” | By Prof Sherif Sultan, MD FRCS FACS PhD

Sherif Sultan writes, "Artificial intelligence momentum will transform and disrupt how medicine works. The application of AI to a cardiovascular health strategy offers limitless opportunities as it provides a continuous source of data-driven insights to optimize biomedical research, precision imaging, early public health primary intervention, and overall superior healthcare quality improvement." Read on.

Mergers / Acquisitions

Boston Scientific Announces Agreement to Acquire Relievant Medsystems, Inc.

″We anticipate this novel, clinically-backed technology can support our category leadership strategy while expanding access to care for individuals who need personalized treatment,″ said Jim Cassidy, president, Neuromodulation, Boston Scientific. ″Upon close, we look forward to working with the Relievant team to explore opportunities to bring this high-growth therapy to a wider population of people living with chronic low back pain.″

Theken Companies Acquires VisionAir Solutions

Randy Theken, Founder of Theken Companies, said of the acquisition, "I was truly overwhelmed by the technology created by the VisionAir team at Cleveland Clinic. The VisionAir 3D Patient-Specific Stents provide significantly improved stent life and an improved patient quality of life. This is exciting not only for the pulmonary field, but for the potential to apply this technology to other medical devices."

Frontage Laboratories Acquires Nucro-Technics Inc. and Nucro-Technics Holdings, Inc.

Abdul Mutlib, CEO of Frontage Laboratories.  "Nucro-Technics has been recognized as a leader in the Canadian CRO market for over 50 years, and its unparalleled client services are a perfect match for the culture of Frontage Laboratories.  This acquisition not only significantly strengthens our presence in Canada, but also will enable the combined organization to offer a more expansive suite of services to clients across the globe.  We are looking forward to partnering with the Nucro team to deliver the world-class expertise that clients have come to expect from us."

GROWTH / DEVELOPMENT

Summus Raises $19.5 Million

Fundraise supports market expansion with Summus emerging as the premier clinical platform to share and access high quality specialty expertise across the continuum of care — serving employers, payers, health systems and physician groups.

Thirona Raises €7,5 Million New Financing to Accelerate the Adoption of its Breakthrough Innovations for Precision Medicine

With this financing, Thirona plans to accelerate the adoption of its break-through innovations for precision medicine.

Levee Medical Secures $4.3M Strategic Investment to Accelerate Clinical Development of the Voro Urologic Scaffold, Designed to Improve Robotic Prostatectomy Outcomes

The trial will evaluate the safety and performance of the Voro Urologic Scaffold as a prophylactic treatment for post-prostatectomy stress urinary incontinence, notes Levee Medical.

FDA

FDA Grants Fast Track Designation to 9MW3011

9MW3011 has been approved to clinical study by NMPA and FDA, respectively. The first person has been dosed in the clinical study in China in March, 2023.

MicuRx receives FDA Qualified Infectious Disease Product (QIDP) and Fast Track Designation for Contezolid and Contezolid acefosamil

"We are pleased to gain the QIDP and Fast Track designations for DFI as recognition that contezolid and contezolid acefosamil are novel new agents to meet an important unmet need in this common and challenging infection", stated Dr Zhengyu Yuan, Chief Executive Officer at MicuRx. 

Via Nova Therapeutics Announces FDA clearance of Investigational New Drug (IND) Application for VNT-101

"We look forward to evaluating VNT-101 in the clinic," said Don Ganem MD, Co-Founder and CEO of Via Nova Therapeutics. "This is an important step to developing a flu antiviral with a novel mechanism of action, and a milestone for Via Nova Therapeutics as we advance our first compound into the clinic."

Executives on the Move

Carthera Appoints Dr Oern Stuge as Chairman of Board of Directors

Dr Oern Stuge brings 30+ years expertise with a wealth of experience in product development and commercial launches to support Carthera’s future growth.

Cytomos Appoints a New Director as £4 Mill Investment Sets Path for Commercialisation of Groundbreaking Cell Analysis Technology

The biotech company’s appointment of industry leader Dr Sharon Brownlow as Non-Executive Director further enhances Cytomos’ senior management team and its unique value proposition to key industry markets.

Kindeva Drug Delivery Appoints Brian Schubmehl as Chief Human Resources Officer

Brian Schubmehl brings more than two decades of diverse and senior global leadership expertise that has spanned private equity, startup, and publicly traded organizations.

Market Reports

Medical Device Summit

Noteworthy

PHYSICIAN / MEDICAL EDUCATION / MARKETING

Impact of Technology on Medical Advancements

Technology has greatly improved medical services and made significant changes in how doctors help people stay healthy. Are you wondering- how? Nowadays, experts can make fake bones and organs with...

What Are the Top Skills Every Future Doctor Needs to Perfect?

Becoming a doctor is a noble and challenging pursuit. It's a profession that requires a unique blend of scientific knowledge, technical skills, and human empathy. As medical science advances...

Systematic Education for Sedation: A Guide for Hospital Leaders

Sedation is a vital procedure in patient treatment and care. When appropriately done, it enables patients to tolerate medical procedures more comfortably by reducing the perception of pain, agitation,...

Community Care Impact: Making A Difference With Doctor Jobs

The medical field constantly undergoes transformation, and doctors are pivotal in spearheading these changes, from technological advancements to evolving patient care standards. However, community care impact often remains underappreciated...

Nurses Corner

Association News

CEUS Underutilization May Pose Greater Risk Than Rare Side Effects Associated With Use, Say Experts

The conference drew CEUS experts from North America, Europe, China and Brazil, and focused on advances in the use of “microbubble” ultrasound enhancing agents (UEAs) used routinely worldwide to diagnose heart and vascular disease, identify and characterize tumors, monitor chronic gastro-intestinal diseases, evaluate other serious medical conditions and monitor therapy. UEAs do not contain dye, create no known risk of kidney damage or deposit of contrast media in the brain, and do not expose patients or hospital staff to ionizing radiation.

Society for Vascular Surgery Foundation Launches September Vascular Health Step Challenge During PAD Awareness Month & Healthy Aging Month

The Society for Vascular Surgery Foundation invites the community to join our September Vascular Health Step Challenge and quite literally take steps toward better vascular health," says Dr. Joseph Mills, SVS President. "PAD affects more than 10 million people in the U.S., but walking an average of 30 minutes or more each day can lower the risk of PAD. Together, we're working to raise awareness, raise our step counts, and raise vital funds to help low-income PAD patients."

Health

Articles of Interest

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