- SynGenSys introduces NK.SET synthetic promoter library to advance natural killer cell therapies
- Medtronic doubles London presence to create global hub for AI and robotics in surgery
- Pharma Tech Industries Names Sam Ricchezza as Senior Managing Advisor, Commercial Operations
- Surgical Plume: The Hidden Hazard in the OR | By Dr Stuart Grant
- No Difference in Transplant Outcomes Seen for Patients Unlikely to Find a Matched Unrelated Donor When a Donor Search Prognosis Strategy is Used
- Cardiosense Appoints Eric Meizlish as CEO to Advance AI-Enabled Cardiac Care
- Medtronic secures FDA approval for the Altaviva™ device, a simple experience for treating urge urinary incontinence
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
Thirona and COPD Foundation Partner to Advance AI-Driven Phenotyping of COPD Patients
This collaboration aims to extract and validate a range of AI-based quantitative CT (QCT) measures, identifying imaging biomarkers that hold the greatest potential for improving COPD phenotyping and advancing precision care.
Guided Spinal Navigation Landmark Surgery Opens the Door to Cost-Effective 3D Augmented Reality
A groundbreaking surgical procedure was successfully performed on a small island in the Mediterranean, marking a significant advancement in spinal surgery.
Nihon Kohden Payment Solutions Launches to Help Healthcare Facilities Acquire Critical Tech
With customizable plans and flexible payment structures, NK Payment Solutions empowers hospitals to invest in advanced patient monitoring and diagnostics technologies while preserving cash flow, existing credit lines and long-term financial flexibility.
Pulse Health Successfully Achieves ISO/IEC 27001 Certification
The ISO/IEC 27001 certification was conducted by leading compliance assessor A-LIGN, a technology-enabled security and compliance partner trusted by more than 4,000 global organizations to help mitigate cybersecurity risks.
Clinical Trials
Revolo Biotherapeutics Announces New Preclinical Data Further Validating Atopic Dermatitis as a Target Indication for ‘1104
Revolo Biotherapeutics notes the data reinforces the broad clinical applicability of ‘1104, through a novel upstream mechanism of action (MOA), demonstrating its impact across skin disease measures and a wide range of inflammatory cytokines and chemokines associated with AD pathology.
Tivic Health Receives Approval from Institutional Review Board for ncVNS Optimization Study, Readies for Enrollment
Tivic Health reports this clinical research collaboration with Feinstein is designed to advance the development of Tivic Health’s ncVNS technology by refining and optimizing stimulation parameters.
New Data Presented at ESMO 2024 Show that Veracyte’s Decipher Prostate Test Predicts Chemotherapy Benefit in Patients with Metastatic Prostate Cancer
“The Decipher Prostate test’s ability to help guide treatment for patients with localized prostate cancer is already proven in dozens of peer-reviewed publications and is the only molecular test to achieve ‘Level 1B’ evidence status in the most recent NCCN® Guidelines* for prostate cancer,” said Elai Davicioni, Ph.D., Veracyte’s medical director for Urology. “These new phase 3 data from the STAMPEDE trial now further prove the performance and utility of our test in patients with metastatic prostate cancer. We believe our test can have a tremendous positive impact on care for these patients.”
Biotechnology News
Capricor Therapeutics Completes Submission of Biologics License Application to the U.S. FDA for Deramiocel for the Treatment of Duchenne Muscular Dystrophy
“The submission of the BLA marks a pivotal step for Capricor Therapeutics and those impacted by DMD. This BLA is the culmination of a body of work that has been focused on bringing this potentially transformational therapy to those patients in need,” said Linda Marbán, Ph.D., Chief Executive Officer of Capricor. “We believe that the strength of this application is that deramiocel has shown in multiple clinical trials attenuation of the cardiac implications of DMD. We look forward to working with the FDA throughout the review process to support this potential approval.”
PharmaEssentia Reaffirms its Commitment to Robust and Reliable Access to Interferon Therapies Amid Global Supply Challenges
“Our longstanding commitment to operational resilience has positioned us to navigate these challenges effectively,” said Dr. Ko Chung Lin, CEO of PharmaEssentia. “We recognize that dependable medication supply is essential, and we are working closely with our partners around the world to ensure the continuity of these important therapies. We have made substantial investment to ensure that all of our supply chain elements are strong, of the highest quality, and reliable.”
YolTech Therapeutics Granted FDA Orphan Drug and Rare Pediatric Disease Designations for YOLT-203 to Treat Primary Hyperoxaluria Type 1
After reviewing YolTech Therapeutics submission, the FDA determined that the therapy is not only appropriate for primary hyperoxaluria type 1 (PH1), but also applicable to the broader category of primary hyperoxaluria (PH). As a result, the designations were granted for PH, reflecting the expanded scope of the therapy’s potential impact. These dual designations underscore the transformative potential of YOLT-203 to address this rare and life-threatening genetic disorder.
Our Experts – Byline Articles
Read Their Views & Share With a Colleague or Two!
Paying it Forward with Dr. Elliott Trotter During American Heart Month
For this American Heart Month, Dr. Trotter is equipping Scribes with essential life-saving knowledge, providing CPR training and enabling them to make a meaningful impact during life or death situations. Read on.
A Look at Cyber In Healthcare in 2024 | Ryan Gonzales – Vice President of Solutions and Security Services at Cylera
Last year was one of the worst years ever for cyber attacks on healthcare organizations. According to John Riggi, national advisor for cybersecurity and risk for the American Hospital Association, the number of people affected by attacks broke records, with US federal data indicating that around 106 million people were impacted by a healthcare data breach, more than double when compared to 2022.
Urgent Care Centers Are Moving Toward Safer Medical Devices for Body Jewelry and Fishhook Removal, Like the Moby Cutter™ | By Anthony G. Stanley, MD
Moby Cutter™ is one of the safest surgical wire cutters on the market today! Their medical design team has over 35 years of experience performing surgical procedures in Hospitals, Emergency Rooms and Urgent Care Systems. It has been cleared for commercialization per FDA guidelines and sold as a prescription only (Rx) medical device. Dr. Stanley shares the advantages of the Moby Cutter.
Executives on the Move
Peytant Solutions Welcomes Craig Walker, MD as Chief Medical Officer
Dr. Walker, a globally recognized key opinion leader, joins Peytant Solutions with a distinguished combination of clinical practice, medical research, and product development experience and will oversee all current and future clinical applications of Peytant’s initial flagship product, the AMStent® Tracheobronchial Covered Stent System.
Sidney S Simmons III Joins ACU-Serve as EVP of Sales
Based in Jacksonville, Florida, Sidney S Simmons brings a wealth of experience and a proven track record in driving sales growth and fostering industry-leading teams.
JD Simpson Appointed CCO of Peytant Solutions
JD Simpson has over 20 years of experience building first-in-class commercial organizations for early-stage medical device companies launching disruptive technologies. Additionally, JD brings a wealth of senior executive experience executing strategic partnerships, institutional financings, new product development, and cross functional department management.
FDA Medical Device Updates
Comprehensive Insights into Medical Device & Biotechnology Company Mergers, Acquisitions & Funding
R3 Vascular Announces $87 Million in Series B Financing
R3 Vascular will use the proceeds to support the ELITE FDA IDE pivotal trial of its best-in-class bioresorbable scaffold, MAGNITUDE®, for below-the-knee (BTK) PAD.
Nami Surgical Secures Investment to Transform Robotic-Assisted Surgery Market
Nami Surgical develops miniaturised ultrasonic medical devices for surgical applications, and supports medical device companies to deliver innovation in ultrasonic surgery. In a groundbreaking development, Nami has introduced a high-performance, miniaturised ultrasonic scalpel, overcoming significant barriers in robotic-assisted surgery. Traditionally favoured in laparoscopic procedures, ultrasonic scalpels have been too large for effective use in robotic surgery until now.
AISAP Raises $13 Million in Seed Funding for First AI-Powered, Point Of Care Ultrasound Diagnostic Solution
“Obtaining an accurate ultrasound diagnosis in time can literally be the difference between life and death, so the fact that so many patients are forced to wait up to a month for one is nothing short of a global health crisis,” says AISAP CEO Roni Attali. “This problem is particularly acute in rural areas or those with fewer resources, and therefore disproportionately impacts disadvantaged populations.”
Vitestro Secures $22 Million (€20 million) for Autonomous Blood Draw Device
Co-led by return investor Sonder Capital and new investor NYBC Ventures, with participation from Invest-NL, the European Innovation Council Fund (EIC Fund), and existing private investors, the oversubscribed funding round will support Vitestro’s commercialization in Europe and its organizational expansion into the U.S. market.
Market Reports
Advancements In Imaging
Phillips-Medisize Teams with GlucoModicum to Develop an Innovative Needle-Free Continuous Glucose Monitor
GlucoModicum is an innovative medtech company based in Finland, to design and eventually commercialize a proprietary non-invasive, wearable device that removes technology and patient-care roadblocks to continuous glucose monitoring (CGM).
Fujitsu and iSurgery Launch Bone Health Promotion Project in Japan with Jikei University School of Medicine Aiming for Early Detection of Osteoporosis
In this demonstration, the project group will utilize iSurgery’s AI medical device, the medical image analysis software Chest Bone Indicator (3) (AI medical device), to assess bone health from chest radiographs and notify the results of health examinations for Fujitsu Group employees.
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.
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
Maximizing Patient Care with Flexible Dental Staffing Solutions
A strategic approach dental clinics can opt for is to maximize patient care with flexible dental staffing solutions. Such solutions can offer numerous advantages including cost-efficiency, access to specialized skills, maintaining a high level of patient care, and so on.
Blending Emerging Healthcare Technologies with Modern Medical Furniture in the Post-COVID Era
This article explores the integration of emerging healthcare technologies with modern medical furniture, focusing on products like Procedure Chairs, 3-Section Treatment Tables, Examination Tables, and Podiatry Chairs, and how they are evolving in response to these advancements.
Expert Moves: The Essential Guide to Choosing Lab Moving Companies
Discover the essential factors to consider when choosing a lab moving company. Learn how specialized services, experience, and proper planning can ensure a seamless and secure lab relocation.
Laser Cutting in Medical Device Manufacturing: A Comprehensive Guide
Laser cutting plays a critical role in medical device manufacturing, offering unmatched precision, flexibility, and efficiency. Read on.This article delves into why and how laser cutting is pivotal in this field, exploring its mechanics, types, materials, and implications for the future of medical technology.
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