- R3 Vascular Secures WCG IRB Approval and CMS Category B Medicare Coverage for the ELITE-BTK Pivotal Trial of its MAGNITUDEÒ Drug Eluting Next Generation Bioresorbable Scaffold for Below-the-Knee Peripheral Arterial Disease
- Vergent Bioscience Receives FDA Fast Track Designation for Abenacianine for Injection (VGT-309) to Help Surgeons Visualize Tumors in the Lung During Surgery
- Capricor Therapeutics Completes Submission of Biologics License Application to the U.S. FDA for Deramiocel for the Treatment of Duchenne Muscular Dystrophy
- PharmaEssentia Reaffirms its Commitment to Robust and Reliable Access to Interferon Therapies Amid Global Supply Challenges
- 50% of Older Adults to Rely on Wearables for Life-Saving Alerts by 2034, ScienceSoft Predicts
- YolTech Therapeutics Granted FDA Orphan Drug and Rare Pediatric Disease Designations for YOLT-203 to Treat Primary Hyperoxaluria Type 1
- AI Hype vs. Reality: Medical Billing’s Need for Human Expertise | By John T Bright, CEO & Founder at Med Claims Compliance Corporation (MCC)
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Medical Device Industry News: Latest Developments, Breakthroughs, and Future Outlook
What Are The Basic Things A Medical Laboratory Needs To Have?
In this article, we will provide an overview of some of the critical elements required for any successful medical laboratory setup – from high-tech equipment and supplies to staff training and regulatory compliance issues.
Ormco Unveils A Refreshed Brand Identity While Staying True to Core Values
As part of its commitment to driving the future of orthodontics, Ormco continually invests in doctor-inspired innovations. Ormco has more than 1000 patents worldwide and invests millions annually in Research & Development to ensure its products continue to respond to the evolving needs of orthodontists and patients.
Centinel Spine® Quickly Achieves 1,000 Procedures with prodisc C Vivo and prodisc C SK Cervical Total Disc Replacement System as Rapid Market Adoption Continues
“The Match-the-Disc™ system of prodisc C Vivo and prodisc C SK, along with the original prodisc C, is exhibiting exponential growth,” observes Centinel Spine CEO Steve Murray. “With the addition of more instrument sets throughout the year, we will strive to support the unprecedented demand for this unique, paradigm-shifting total disc replacement system
Orange Biomed Launches in U.S. Market to Reduce Inaccuracies in Diabetes Diagnosis for Minorities and Help Manage Diabetes at Home with a Revolutionary POC A1c Test
Park continued, “OBM rapid A1c is a portable, guided, five-minute test requiring only a single drop of blood to produce accurate results. By seamlessly integrating lab-level technology into portable devices, we seek to make healthcare more accessible, accurate, and affordable for everyone.”
Clinical Trials
Inspira Technologies Announces First in Human of HYLA Blood Sensor in Clinical Study
The HYLA Blood sensor is a non-invasive optical blood sensor, being developed using machine learning based algorithms to measure blood key parameters, continuously and in real-time during extracorporeal procedures including VV-ECMO, VA-ECMO and open-heart surgery.
Ancora Heart’s AccuCinch System Demonstrates Significant Improvement in Quality of Life, Cardiac Structure and Function in Heart Failure Patients
Dr. Hamid. “We witnessed significant and progressive reverse remodeling of the left ventricle, as well as significant and sustained improvement in quality of life and functional capacity measures. These results show promise that this innovative catheter-based therapy may help broaden options for treating patients with heart failure, and we look forward to results of the pivotal study that’s underway.”
Todd Lanman MD Announces Completion of First Lumbar Total Joint Replacement Procedure in California as Part of a Clinical Trial
Tom Lanman MD “The century-old ‘go-to’ procedure of fusing the spine should be a thing of the past. We strongly believe that at least half of fusions in the U.S. should never have been done in the first place. Every other joint in the body gets a replacement, and the spine should be no different.”
Biotechnology News
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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
Market Reports