- Phenomix and Mayo Clinic Publish Research Demonstrating Utility of MyPhenome Test for Personalized GLP-1 and Phen-Top Treatment
- Solventum Launches Preassembled, See-through VH2O2 Test Pack for Low-temp Medical Instrument Sterilization
- TYBR Health Announces FDA 510(k) Clearance for B3 GEL™ System
- The EHR + RCM Combo That Mental Health Practices Have Been Waiting For
- Clinilabs Expands Executive Leadership Team With Key Appointments
- Eye’ on Health: AI Detects Dizziness and Balance Disorders Remotely
- FastWave Medical Announces Successful First-in-Human Procedures in Study of Sola, Its Next-Generation Coronary Laser IVL System
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Medical Device News Magazine delivers the latest updates from the medical device and biotechnology sectors. We take pride in offering high-quality, in-depth content, crafted by a team of experienced professionals. Our goal is to provide a unique perspective on the trends and innovations driving the future of medical technology. By reading our articles, you’re not only gaining exclusive industry insights but also becoming part of a community committed to advancing healthcare through groundbreaking technologies. Explore our content and consider partnering with us for advertising opportunities!
Medical Device Industry News: Latest Developments, Breakthroughs, and Future Outlook
Valencia Technologies Announces CMS Publication of 2025 Medicare Proposed Rule for eCoin® Procedure
Ann Decker, VP of Reimbursement for Valencia Technologies, stated, “The cumulative effect of the proposed 2025 continuation of APC assignment 5464, the improved ASC payment rate, and the recognition of ITNS as a minimally invasive OAB treatment option in the recently updated guidelines by the American Urological Association (AUA) and the Society of Urodynamics, Female Pelvic Medicine, and Urogenital Reconstruction (SUFU), underscores that the eCoin ITNS system will have a strong reimbursement pathway throughout 2025 and beyond.
VitaFlow Liberty ™ Granted EU CE-MDR Mark
Jeff Lindstrom, President of CardioFlow, stated, “The certification of VitaFlow Liberty by the CE regulatory body under MDR, is a testament to CardioFlow’s world-class R&D, quality, and clinical capabilities. This recognition will expedite the global clinical adoption of the VitaFlowTM series along with other innovative products, advancing CardioFlow’s globalization strategy. This achievement also positions us to make a more substantial contributions to developments in the field of heart valve interventions, ultimately benefiting patients across the globe.”
Inspira Receives 1st Ever Purchase Order for INSPIRA™ ART100 Systems in the U.S.
Inspira reports the first units are expected to be shipped in Q4 2024. The Purchase Order follows the recent FDA Clearance of the INSPIRA™ ART100.
Sharps Technology Receives $30 Million Purchase Order for Prefillable Copolymer Syringes to be Manufactured at SC Facility
The purchase order includes deliveries for both the 10mL and 50mL specialty copolymer prefillable syringes that will be manufactured at the West Columbia site being acquired from Nephron. This assurance of supply is expected to support the planned expansion of the 503b operations at the Nephron site. The new copolymer syringe technology reflects the pharmaceutical and healthcare industry’s trend toward transitioning injectable drug therapies into innovative polymer prefillable syringes and away from the older glass and standard plastic syringes reports Sharps Technology.
Clinical Trials
Orlucent Demonstrates Accurate, Non-Invasive Detection in vivo of Melanoma-Related Activity Using First-in-Kind Handheld Mole Imaging System
The Orlucent system will be the first to provide clinicians with a noninvasive direct measure of early intra-cellular activity and shows promise to transform the landscape of identifying melanoma at its earliest stage.
Identifai-Genetics Launches Its 1st U.S. Clinical Trial | Led by Professor Ronald Wapner
Identifai-Genetics advises the principal investigator in the study is world-renowned Professor Ronald Wapner, Director of Reproductive Genetics and Professor of Obstetrics and Gynecology at Columbia University Irving Medical Center.
Rivermark Medical Reports Expanded Indication Study for FloStent System
Rivermark’s FloStent System is a uniquely engineered nitinol stent that gently holds the prostatic urethra to restore normal urinary flow and provide rapid relief for patients with BPH. The system can be deployed during an outpatient procedure using any flexible cystoscope, offering a therapeutic intervention at the time of diagnosis with fewer complications and minimal recovery time.
Biotechnology News
Preci and Biopredic International Partner for Higher Performance of Suspended Pooled Hepatocytes with Extended Longevity and Large-scale Availability
Under a license agreement, Biopredic will leverage Preci’s expertise and production capacity in sourcing primary hepatocytes, and combine with its own IP and know-how in cell pooling. The partnership will provide DMPK researchers access to large batches of high-performing suspended pooled hepatocytes with extended longevity from multiple donors.
The Future of Biotechnology: Insights Into Cutting-Edge Developments
The future of biotechnology holds immense promise, with continued advancements driving innovation and progress across various sectors. From gene editing and synthetic biology to biopharmaceuticals and beyond, the possibilities are endless. By staying informed, collaborating with industry leaders, and leveraging cutting-edge technologies, we can harness the power of biotechnology to address some of the most pressing challenges facing humanity.
Advancing Patient Care: LyGenesis Doses First Patient in Phase 2a Trial
“In a medical first, we have now dosed our first patient in a clinical trial using their own lymph nodes as living bioreactors to regenerate an ectopic organ,” said Dr. Michael Hufford, Co-Founder and CEO of LyGenesis. “This therapy will potentially be a remarkable regenerative medicine milestone by helping patients with ESLD grow new functional ectopic livers in their own body. If our study is successful and we obtain FDA approval, our allogenic cell therapy could enable one donated liver to treat many dozens of ESLD patients, which could help to tilt the current organ supply-demand imbalance in favor of patients.”
Our Experts – Byline Articles
Read Their Views & Share With a Colleague or Two!
Digital Pathology Reaches an Inflection Point as AI Targets Workflow Gaps | By Yair Rivenson, PhD Founder and CEO, Pictor Labs
Laboratories face mounting pressure to modernize imaging, preserve tissue, and reduce sequencing failures as adoption continues to move at a glacial pace
FIZE Medical Launches 5,000-Patient Retrospective Study to Further Establish the benefits of using FIZE kUO in managing ICU patients’ Hemodynamic status
By continuously capturing renal function patterns, the study aims to demonstrate how FIZE kUO® can provide data for early signs of instability that are often missed by intermittent measurements
Skin May Become the First Organ to Fulfill the Promise of Regenerative Medicine | By Dr. Ned Swanson – President & Chief Medical Officer of PolarityBio
The field of regenerative medicine may be on the cusp of an evolution, and due to the unique attributes of skin and wounds, the largest organ in the body may be emerging as a leader
FDA Medical Device Updates
Comprehensive Insights into Medical Device & Biotechnology Company Mergers, Acquisitions & Funding
Whisker Sells One Millionth Robot and Completes Its $10M USA Manufacturing Expansion
The Litter-Robot 4 was meticulously designed by the Whisker Team, taking more than 20 years of product innovation and experience into consideration.
RedBrick AI Raises US$4.6M
RedBrick AI is building the foundation of healthcare artificial intelligence (AI) with its medical data annotation tools for imagery
Wesper Announces $9.6 Million Series A Round
With FDA clearance and insurance coverage, Wesper has crafted a clinical-grade solution to deliver sleep medicine to the masses.
Ceros Financial Services Arranges $7.5 Million Financing for Wesper
Wesper Home Sleep Lab features a wearable device that monitors sleep conditions For clinical-grade evaluation, analysis and treatment.
Market Reports
Advancements in Imaging
Carestream’s Lux 35 Detector Wins Frost & Sullivan New Product Innovation Award
“The Frost & Sullivan Award is another validation of our research and development team’s continued success at developing solutions that incorporate cutting-edge technology to improve radiology workflow and enhance patient care,” said Dharmendu Damany, Chief Technology Officer at Carestream.
MinXray Sets Up Base Camp at Mount Everest
MinXray and Qure.ai conducted system demonstrations for MinXray’s Impact battery-powered portable digital radiography system with qXR Automated Chest X-ray AI Solution from Qure.ai. The new AI software can detect and localize 30 chest X-ray abnormalities including Tuberculosis.
KA Imaging Announces the Initial Results from a Study Examining the Diagnostic Value of Single-Exposure Dual-Energy Subtraction Radiography in Lung Lesion Detection
KA Imaging notes the initial results from the clinical trial on lung lesion detection will be presented at ECR 2022.
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
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