FDA Qualifies MolecuLightDX Wound Measurement as a Medical Device Development Tool (MDDT) for Evaluating New Products in Wound Care

MolecuLight today announced that its MolecuLightDX® wound measurement has been qualified by the U.S. Food and Drug ...
Healthcare Dive

AI devices with no clinical validation tied to more recalls, study finds

Artificial intelligence-enabled medical devices with no clinical validation were more likely to be the subject of recalls, according to a study published in JAMA Health Forum. The study, published on ...

Panakeia publishes landmark clinical validation showing AI can deliver rapid molecular profiling for colorectal cancer

Panakeia publishes landmark clinical validation showing AI can deliver rapid molecular profiling for colorectal cancerLargest real-world, ...
EurekAlert!

Almost half of FDA-approved AI medical devices are not trained on real patient data

Artificial intelligence (AI) has practically limitless applications in healthcare, ranging from auto-drafting patient messages in MyChart to optimizing organ transplantation and improving tumor ...

AI health software now mandates government licence and clinical trials

India has brought AI-based diagnostic software under medical device regulations, mandating government licences and clinical ...

MDR Certified CPAP Respiratory Device Manufacturer vs Standard CPAP Producers

DONGGUAN, GUANGDONG, CHINA, January 15, 2026 /EINPresswire.com/ -- As global healthcare regulations tighten and patient ...

1927nm Fractional Thulium Laser Technology Gains Wider Clinical Adoption in Skin Rejuvenation Applications

WEIFANG, SHANDONG, CHINA, January 21, 2026 /EINPresswire.com/ -- Introduction: A Global Innovator from Shandong, China ...
Morningstar

From Validation to Scale: Vektor Medical Closed 2025 with Clinical Momentum and Global Progress

From Validation to Scale: Vektor Medical Closed 2025 with Clinical Momentum and Global Progress Vektor Medical, a medical technology company transforming cardiac arrhythmia care, announced key ...

Top 3D Printed Silicone Medical Simulators Manufacturer Driving the Future of Clinical Training and Patient Safety

NINGBO, ZHEJIANG PROVINCE, CHINA, January 19, 2026 /EINPresswire.com/ -- In recent years, the global healthcare ...

Nitinol-Based Medical Device Market Size to Reach USD 7.55 Billion by 2033, Driven by Minimally Invasive Procedures and Advanced Manufacturing – SNS Insider

Growing adoption of cardiovascular and urological implants, AI-enabled manufacturing, and demand for cost-efficient care accelerate global market expansion.Austin, Texas, Jan. 28, 2026 (GLOBE NEWSWIRE ...