If devices are integral to positive patient outcomes, device partners must play an integral role to ensure regulatory ...

Biocompatibility assessment per ISO 10993 ensures medical device safety by evaluating materials, risks, and biological ...

Needles and syringes are commonly used to retrieve cell therapies from vials, posing the risk of needle stick injury. Explore ...

Enhancing catheter visibility under fluoroscopy, custom radiopaque filler blends improve imaging clarity without compromising ...

Thermoplastics revolutionized medical technology by replacing glass with flexible PVC. Learn how their versatility supports advanced healthcare applications, from wound care to life-saving devices.

As the medical device industry continues to expand, intellectual property (IP) considerations — especially those concerning patents — are critical for medical device innovators and manufacturers.

Thin film extrusion technologies are transforming medical device innovation by enabling flexible and durable components.

Discover how medical device manufacturers are leveraging advanced techniques like thermoforming and dip molding to create customizable low-pressure balloons that enhance reliability and compliance.

Artificial intelligence (AI) and machine learning (ML) are redefining healthcare, from enabling earlier diagnoses and personalized treatments to streamlining hospital operations and accelerating ...

Recent advances in AI, including machine learning, natural language processing, and deep learning models, are transforming rare disease diagnosis.

In medical device design, simplicity isn't just a luxury — it’s a necessity. When creating devices for users who may be in pain, under duress, or untrained, the goal is clear: make it simple. Medical ...

The FDA’s final guidance on Predetermined Change Control Plans (PCCPs) for AI-enabled device software functions (AI-DSFs) has arrived, replacing the draft guidance issued in April 2023. While the ...