In the medical device industry, usability plays a critical role in ensuring the safety and effectiveness of highly complex medical products. The IEC 62366-1:2015 standard, which focuses on the ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

The integration of artificial intelligence (AI) into the design of medical devices heralds a new era in healthcare—one where innovation meets precision to significantly enhance patient outcomes. This ...

Designers and engineers have often looked to the environment and how Mother Nature has accomplished phenomenal design solutions for inspiration over the ages. Perhaps all that is new about this ...

Latest developments in AI hardware and software are revolutionizing medical device development, where the technology is now widely used to process, predict, and visualize medical data in real time. AI ...

"We are headed down the road of increasing development and utilization of devices to treat heart failure," Dr. William ...

"A medical device can be any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the ...

April 9, 2010 — In its latest effort to reduce the risks of medical radiation, the US Food and Drug Administration (FDA) yesterday notified manufacturers of radiotherapy equipment such as linear ...

FDA clearance is a vital milestone for ASX medical device companies, opening access to the US market while navigating the regulatory process.