Novartis today announced that the European Commission (EC) has approved Itvisma® (onasemnogene abeparvovec) for the treatment of children two years and older, teens and adults living with 5q spinal muscular atrophy (SMA) with a bi-allelic mutation in the survival motor neuron 1 (SMN1) gene. With this approval, Itvisma becomes the first and only gene replacement therapy currently approved for this broad SMA population in the European Union. Itvisma is uniquely designed

SkylineDx,  innovative diagnostics company specializing in the research and development of molecular diagnostics for dermatology and oncology, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Merlin CP-GEP¹ , a clinicopathologic gene expression profile (CP-GEP) test designed to support risk assessment and clinical decision-making in patients with early-stage cutaneous melanoma. The FDA's Breakthrough Device

Aurenar, developer of a non-invasive neuromodulation platform for patients in intensive care, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its V-Link™ System for the reduction of cerebral vasospasm in adults with aneurysmal subarachnoid hemorrhage (aSAH). The designation applies to the use of V-Link in adult patients (22 years of age and older) with aSAH as an adjunct to clinical management to reduce the incidence of cer

Baird Medical Investment Holdings Ltd. (NASDAQ: BDMD) ("Baird Medical" or the "Company"), a market leader in minimally invasive Microwave Ablation (MWA) technology, today announced the successful completion of the first procedures using its MWA technology in Vietnam and Argentina. In Vietnam, the first clinical case using the Company's MWA technology was completed at Lac Viet Friendship Hospital on June 18. The procedure was performed by Dr. Dinh Xuan Ha, Dep

Olympus Corporation (Olympus), a global MedTech company committed to advancing endoscopy-enabled care, today announced a reseller agreement with First Nation Group, a premier Service-Disabled Veteran-Owned Small Business (SDVOSB), Veteran-Owned Small Business (VOSB), and Small Business distributor serving federal healthcare customers nationwide.  Under the agreement, First Nation Group will serve as an authorized SDVOSB reseller for Olympus America Inc. (OAI), providing federal

CereVasc, Inc., a clinical-stage medical device company developing novel, minimally invasive treatments for neurological diseases, announced it has completed patient enrollment in its STRIDE pivotal trial evaluating the investigational eShunt System in patients with normal pressure hydrocephalus (NPH). With patient enrollment complete at 32 clinical sites, STRIDE is progressing through remaining treatment and follow-up activities for consented patients, keeping the company on track

Baystate Health, a not-for-profit, integrated health system in western Massachusetts, is expanding its strategic relationship with Oracle Health to create a more connected healthcare experience for patients and clinicians. Through this initiative, Baystate Health plans to accelerate the adoption of Oracle Health technologies across its network, including its health plan, Health New England. This modernization journey will be enabled by AI-powered solutions including Oracle Health EHR, Oracle

Cook Medical’s new SureTome™ SW Sphincterotome with DomeTip® is now available in the United States and Canada. This next-generation sphincterotome enables advanced gastrointestinal endoscopists to easily and reliably access the hepatopancreatobiliary system. SureTome SW is an innovative addition to Cook’s portfolio of Endoscopy devices and continuing pipeline of new products.   The SureTome SW offers key features such as:

Marcus Evans is pleased to announce the return of the Healthcare HR Summit, scheduled for October 19-20, 2026 at the Red Rock Casino Resort and Spa, Las Vegas, Nevada. Now a firmly established fixture in the healthcare HR calendar, the summit convenes the most senior human resources executives from across North America's leading hospital systems and healthcare networks, alongside a carefully selected group of innovative suppliers and solution providers. The Healthcare HR Summit

Flosonics Medical received the Paul and Debra Walker Award, part of the Sepsis Research and Innovation Challenge at the Unite for Sepsis Symposium presented by Sepsis Alliance in Washington, D.C. on June 11, 2026. The recognition comes as FloPatch, the company’s FDA-cleared wearable Doppler ultrasound device, has become a trusted tool for bedside fluid responsiveness assessment across a growing number of U.S. emergency departments and intensive care units. This award recognize