- Biogen to Highlight Scientific Progress Across Alzheimer’s Disease at the Alzheimer’s Association International Conference 2025
- Movora Becomes Exclusive Distributor of Aesculap Surgical Power Systems in North America
- HNL Lab Medicine Opens New Location at Tower Place in Bethlehem
- Unlocking People Potential: The Power of Data to Drive Smarter HR Outcomes and Future Workforce Strategies
- Champions Oncology Announces Appointment of New CEO
- Phase 3 Study of MR-139 for Blepharitis Update Provided by Viatris
- Dr Richard J Friedman Appointed CMO at Exactech
Medical Device News Magazine delivers the latest updates from the medical device and biotechnology sectors.
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Medical Device Industry News: Latest Developments, Breakthroughs, and Future Outlook
Cartessa Aesthetics Partners with Classys to Bring EVERESSE to the U.S. Market
Classys, which is listed on the KOSDAQ, is one of South Korea’s most distinguished aesthetic technology manufacturers, with devices distributed in 80+ markets globally. This partnership marks Classys’s official entry into the American marketplace, with Cartessa Aesthetics as the exclusive distributor for EVERESSE, launched under the Volnewmer brand in current global markets.
Stryker Launches Next-Generation of SurgiCount+
Now integrated with Stryker’s Triton technology, SurgiCount+ addresses two key challenges: retained surgical sponges and blood loss assessment. Integrating these previously separate digital solutions provides the added benefit of a more efficient, streamlined workflow for hospitals notes Stryker.
Nevro Receives CE Mark In Europe for It’s HFX iQ™ Spinal Cord Stimulation System
Nevro notes HFX iQ is the first and only SCS system with artificial intelligence (AI) technology that combines high-frequency (10 kHz) therapy built on landmark evidence that uses ongoing cloud data insights to deliver personalized pain relief
Recor Medical Reports: CMS Grants Distinct TPT Device Code and Category to Recor Medical for Ultrasound Renal Denervation
The approval of TPT offers incremental reimbursement payments for outpatient procedures performed with ultrasound renal denervation for Medicare fee-for-service beneficiaries. It becomes effective January 1, 2025, and is expected to remain effective for up to three years notes Recor Medical.
Clinical Trials
Enliven Therapeutics Announces Positive Proof of Concept Data from Phase 1 Clinical Trial of ELVN-001 in Chronic Myeloid Leukemia
“We are excited to present the first look at the safety and clinical activity of ELVN-001, which we believe supports the potential for ELVN-001 to address the limitations of the available active-site TKIs,” said Helen Collins, M.D., Chief Medical Officer of Enliven. “Across a wide dose range, ELVN-001 demonstrated activity in a heavily pre-treated patient population that includes post-asciminib patients, with a preliminary safety profile consistent with its highly selective design. Not only did all evaluable patients have improved or stable BCR::ABL1 transcript levels, but, importantly, 89% of all patients enrolled remain on study. We believe the initial data demonstrate the potential clinical utility of ELVN-001 for all types of patients, including those that are earlier in the treatment paradigm.”
Ferring Presents Pivotal Phase 3 Efficacy and Safety Data for Investigational Treatment, SI-6603 (condoliase), in Lumbar Disc Herniation at ASIPP 2024
The research, presented at the American Society of Interventional Pain Physicians (ASIPP) Annual Meeting, included a registrational Phase 3 trial and an integrated safety analysis of six clinical studies, as well as a real-world analysis of current treatment options and gaps in the clinical management of patients with newly-diagnosed LDH.
Lunit’s AI Demonstrates Up to 70% Workload Reduction and Enhanced Accuracy in Breast Cancer Screening | Study in European Radiology Reveals
This comprehensive study encompassed over 22,621 mammograms from 8,825 women over a decade. Utilizing Lunit INSIGHT MMG, Lunit’s AI-powered solution for breast cancer detection, the research aimed to assess its proficiency in early cancer detection within a breast cancer screening program.
Biotechnology News
Bio-Rad Launches Celselect Slides 2.0 to Advance Rare Cell and Circulating Tumor Cell Enrichment for Cancer Research
“CTCs are rare — as low as only 1–10 can be found per milliliter of blood — however, CTC enumeration and analysis offers valuable insight into tumor heterogeneity and disease progression,” said Stephen Kulisch, Vice President of Marketing for Bio-Rad’s Digital Biology Group. “Building on the capabilities of Celselect Slides 1.0, we’re continuing to improve the efficiency of rare CTC enrichment, enumeration, and recovery to accelerate cancer research workflows. This launch reflects the expansion of our technological capabilities and our commitment to bringing novel solutions to researchers to improve our understanding of cancer and inform research programs.”
PharmaEssentia Completes Patient Enrollment for Phase 2b EXCEED-ET Trial in Essential Thrombocythemia and Phase 3b ECLIPSE-PV Trial in Polycythemia Vera
“Myeloproliferative neoplasms, including ET and PV, are chronic blood diseases that can impact patients’ quality of life and lead to life-threatening complications, including the development of specific types of blood cancers, and PharmaEssentia is committed to developing new therapeutic solutions for these patients,” said Robert B. Geller, M.D., Head of Medical at PharmaEssentia USA. “We are thrilled with the pace at which we have enrolled patients, which we believe reflects a high level of interest in both the EXCEED-ET and ECLIPSE-PV trials. Our goal with each of these programs is to redefine the early treatment paradigm of myeloproliferative neoplasms.”
SOPHiA GENETICS Launches New Residual Acute Myeloid (RAM) Application
Philippe Menu, M.D., PhD., Chief Medical Officer and Chief Product Officer, SOPHiA GENETICS. “We are proud to contribute to the fight against AML through our SOPHiA DDM™ RAM Solution. In particular we feel that the capability to seamlessly track longitudinally the evolution of individual mutations over time through a dedicated add-on module of our SOPHiA DDM™ Platform has the potential to be a game-changer for clinical researchers.”
Our Experts – Byline Articles
Read Their Views & Share With a Colleague or Two!
Optimizing Hospital Operations: Maximizing Efficiency with Smart Storage Solutions
Hospitals that want to improve the functionality of your department while improving patient reviews and decreasing unnecessary wastage of funds, you should seriously consider replacing your old and ineffective storage system with the latest improvements. Doing so will guarantee excellent results on your investment in terms of patient satisfaction, costs, and staff performance. Read to learn more.
2023 Antitrust and Consumer Protection Developments in Medical Device Manufacturing: Effectively Managing Compliance Risk in an Increasingly Hostile Environment | By: Mark A. Cunningham
Cunningham advises how medical device manufacturers should manage their compliance risk while operating in markets where customers increasingly leverage their purchasing power. Read on to learn more.
From Vision to Reality: Ten Trends Shaping the Future of Healthcare Technology | By Valentin Kuzmenko, Chief Commercial Officer, VP of Sales, Andersen
The field of healthcare is undergoing rapid and continuous advancements, consistently introducing remarkable innovations. Amidst these dynamic changes, hospitals and clinics are embracing the latest breakthroughs and procuring innovative software solutions. Their objective is to deliver exceptional care that enables patients to benefit from the most cutting-edge practices available today. According to Statista’s findings, the Digital Health market is projected to generate a revenue of approximately US$170.20 billion in 2023. This underscores the substantial interest of medical organizations in technological innovations. Kuzmenko dives into ten trends shaping the future of healthcare.
Executives on the Move
FDA Medical Device Updates
Comprehensive Insights into Medical Device & Biotechnology Company Mergers, Acquisitions & Funding
Conformal Medical Raises $35 Million in Oversubscribed Series D Round
The highly supported round reflects the progress and achievements made since its last funding round, which includes the initiation of the CONFORM Clinical Trial. The CONFORM Trial is the company’s pivotal trial evaluating the safety and efficacy of the CLAAS® System compared to other commercially available LAAO devices and will support U.S. Food and Drug Administration (FDA) pre-market approval.
PathMaker Neurosystems Receives $200,000 START Award from MassVentures
“We are grateful for the Stage 2 award from MassVentures as we work to bring MyoRegulator® to market,” said Nader Yaghoubi, M.D., Ph.D., Co-Founder and Chief Executive Officer of PathMaker. “As we continue our US multi-center pivotal trial in post-stroke spasticity and work to launch our first clinical trial in ALS this year, MassVentures support for late-stage development of our product is greatly appreciated.”
Orthonika Awarded £1.34 Million Innovate UK Grant
“There is currently no widely available treatment solution that allows patients to return to a pain-free active lifestyle following meniscectomy,” said Maria Kristina Bartolo, Ph.D., Chief Technology Officer at Orthonika. “We are delighted that Innovate UK has recognised the potential for our novel total meniscus replacement to fulfill a significant unmet clinical need and further promote joint preservation.”
Dr Peter Staats, Chief Medical Officer at National Spine and Pain, Joins the Neuralace Medical Advisory Board
Dr Peter Staats brings extensive expertise to the company and will collaborate with the advisory board and Neuralace Medical to contribute valuable insights and strategic guidance.
Market Reports
Advancements In Imaging
Invenio Imaging Announces Clinical Research Collaboration Agreement
“In this important clinical study, we will develop a novel image analysis algorithm based on machine learning to provide physicians with real-time feedback determining whether a biopsy sample contains cancer”, says Chris Freudiger, PhD, Co-Founder and CTO of Invenio Imaging.
Carestream Unveils Next Generation Detector in Long-Length Digital Imaging
The CARESTREAM DRX-LC Detector (Pending FDA 510(k) clearance) captures long-bone and spine images with a single exposure, making it ideal for pediatric imaging and long-bone and spine images of people with limited mobility.
Canon Medical Components U.S.A., Inc. Announces Launch of New Products in the U.S., to Be on Display at RSNA 2022
Canon Medical Components U.S.A., Inc. is displaying a number of innovative products, some that are now available for the first time in the United States.
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
Benefits of Digital Patient Data Management and its Impact on Healthcare Delivery
The healthcare industry has undergone a transformative shift fueled by technological advancements in recent years. One notable innovation that has revolutionized patient care and administrative
Medical Imaging Technology: A comprehensive overview of advancements in X-ray, MRI, CT, and other imaging modalities
In the ever-evolving landscape of modern medicine, one revolutionary field has played a pivotal role in diagnosis, treatment, and research: Medical Imaging Technology. Each year,
How Blockchain Technology Enhances Security and Efficiency in Medical Recordkeeping and Supply Chains
In recent years, the revolutionary potential of blockchain technology has captured the attention of industries worldwide, transcending its origins in the realm of cryptocurrencies. One
Top IoT Solutions for Healthcare Industry
The rapid advancement of technology has revolutionized various industries, one sector that has seen a remarkable transformation in healthcare. In recent years, integrating the Internet
Healthcare Careers
Nurses Corner
Travel Nurses Can Stay Safe During This COVID-19 and Flu Season
One of the best ways to stay safe is to get the flu shot. Since travel nurses are around those who are sick most of the time, a flu shot will help boost their immune system so their bodies can fight off the germs they are exposed to on a regular basis. Getting the COVID-19 vaccination is also another way travel nurses can help fight germs and viruses this upcoming flu season.
6 Career Choices For Family Nurse Practitioners With A Doctorate
This article will go over six possible careers for Family Nurse Practitioners (NPs) with a doctorate degree in Nursing Practice (DNP). Nurses read on!
Why 2022 Is The Ideal Year To Become A Nurse? Find Out Here
The need for nurses is more urgent than ever before. Discover why 2022 is the ideal year to become a nurse in America.
