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 ...

We are sure you are aware that the EU medical devices framework has been subject to significant changes over recent years. However, implementation of the new rules has been problematic since the ...

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 ...

DSM Biomedical offers hydrophilic, lubricious, non-biofouling coating technologies. DSM offers ready-to-use coating reagents that can be applied onto a range of substrates using various coating ...