This article explores the global regulatory landscape, examining how leading authorities in the U.S., EU, U.K., Canada, China, Brazil, Australia, and South Korea are approaching AI in medical devices.

Mounting concerns that FDA reviewers could start missing PDUFA deadlines have put many on edge. The moment calls for ...

Quality in micro molding is essential. Accumold ensures precision through advanced metrology, process validation, and ...

The recent update to ISO 15223-1, formalized through Amendment 1:2025, ushers in a critical shift for medical device labeling ...

The Lee Company's novel disc pump family, including the UltraSlim (US) Series, offers high-performance, quiet, and compact pressure/vacuum generation with optional electronics. The integrated ...

Healthcare is shifting homeward. With telehealth, connected devices, and user-friendly design, patients and caregivers now ...

In a memorable episode from the medical drama Grey’s Anatomy, the hospital’s entire computer system is hacked and held for ransom. Staff can’t access patients’ medical records, cardiac monitors ...

As mental health disorders continue to climb globally — now affecting nearly 1 billion people — the need for earlier detection, continuous monitoring, and more personalized interventions is more ...

The company designs and builds automated dip molding and dip coating machinery for the manufacturing of medical disposables such as catheters. ACC Automation Co. designs and builds automated dip ...

Watch a comprehensive overview of regulatory requirements and testing standards relevant to disinfectant and cleaning validation in pharmaceutical and medical manufacturing. It begins with a ...