With the FDA's new requirements for premarket submission and ongoing monitoring by medical device manufacturers in place, ...

The medical device sector faces significant changes, as both Donald Trump and Robert F. Kennedy Jr. have identified the FDA ...

Kolaleh Eskandanian, chief innovation officer at Children’s National Hospital, said the partnership is meant to address the ...

The new regulations would withdraw the principle of equivalence and require further clinical trials in medical devices, which would especially affect class III devices. The MEDDEV guidance ...

The trend of growth analysis for vacuum mixing devices has displayed a low end in terms of sales and revenue generation, ...

The United States is currently under the spotlight as Donald Trump’s recent appointment and consequent nomination of Robert F ...

The Medicines and Healthcare products Regulatory Agency (MHRA) has initiated a crucial consultation aimed at reshaping ...

Hemant Vilas Belsare delves into the transformative power of high-value innovation in medical technology, highlighting its ...

Rather than performing all these activities integrally with the development effort where they add real value in terms of ...

Medical devices imported or purchased for use in health care facilities must comply with the Canadian Medical Devices Regulations (the Regulations). Class II, III or IV medical devices require ...