Next generation mitral valve, designed to facilitate patient lifetime management reports first uses in sternotomy, Minimally Invasive Cardiac Surgery (MICS) and robotic cases.
SUNRISE-II feasibility trial marks the company’s entry into U.S. clinical development, advancing minimally invasive, anesthesia-free treatment approach
Edwards announced 10-year results from the COMMENCE aortic trial, reinforcing the long-term durability and sustained performance of its proprietary RESILIA tissue.
Companies and researchers often fail to disclose negative trial results, resulting in significant gaps in the public record and a publication bias that obscures the true landscape of drug development outcomes—overrepresenting successes and underrepresenting failures. This gap can also create a distorted perception of the safety and efficacy of medical products.
The company’s River stent will be available for adults with severe IIH – a debilitating, historically undertreated condition – who have failed medical therapy.
Noah Labs Vox,™ a voice-based algorithm that detects worsening heart failure weeks before hospitalization, has received US Food and Drug Administration (FDA) Breakthrough Device Designation (BDD).
Data has become overwhelming in healthcare. While it has provided tremendous solutions and outcomes, however, it can sometimes be a problem, too! How can data utilization in Clinical Studies and a ground up data strategy help make your technologies, your team, and your trials more efficient?
While some wearables may be tailor made for trial use, they face challenges translating to real-world patient applications outside of a stringent trial setting, and vice versa. This creates a unique challenge for med-devs looking to bring their devices out of the trial setting and into patient care.
The nationwide study will assess the safety and efficacy of the technology that combines standard balloon dilation to open the respiratory tract with drug delivery designed to maintain symptom relief.
The AMStent System leverages a decellularized human amniotic membrane (DCAM). New pre-clinical outcomes demonstrating superior results compared to a commercially available synthetic polymer-covered stent were presented at the 2025 American Association for Bronchology and Interventional Pulmonology (AABIP) Annual Meeting.