Medical device document approvals seem to be a roadblock when you are the most pressed for time. But if the right approvers ...

Discover how integrated microfluidic pumping solutions eliminate bulky external equipment, simplifying cartridge design while ...

Discover how thinXXS helped Pattern Bioscience accelerate digital droplet chip development through precision manufacturing, ...

Examine how medical device manufacturers can improve the economics and reliability of orthopedic implants by rethinking both material selection and processing strategies. Ultra-high-molecular-weight ...

The European Union’s Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746) impose stringent requirements on all economic operators involved in the supply chain of ...

In 2023, the FDA made the electronic Submission Template And Resource (eSTAR) mandatory for most 510(k) submissions. Although eSTAR is not an AI tool, the move was the first definitive leap toward the ...

FDA has now completed just over 100 inspections under its new Quality Management System Regulation, and the agency has begun sharing preliminary observations from those inspections. Early FDA findings ...

SCS devices deliver electrical pulses to the spinal cord to relieve chronic pain. They are often used as treatment for failed back surgery syndrome, injuries to the spinal cord, complex regional pain ...

We are close to a new era in ultrasound technology. From helping healthcare specialists detect several diseases such as cancerous cells to showing real-time images inside the mother’s womb, ultrasound ...

The FDA proposed on Feb. 22, 2022, an update to the Quality System Regulation 1 that was released in 1996. The proposal is to reference ISO 13485:2016 Medical devices — Quality management systems — ...

Across industries, innovation platforms constantly monitor device usage and anticipate future needs, fueling breakthrough ideas in real time. AI agents are dissolving silos in large organizations, ...