South Korea showcases top 10 innovative medical devices at annual report meeting South Korea reveals its top ten groundbreaking healthcare technologies at a major annual event ...

The commercial manufacturing example involves an AI-based visual analysis ... FDA explains what documentation and information should be included in marketing submissions for devices with AI ...

NeuroPace, Inc. (NASDAQ:NPCE), a medical device company specializing in neurological disorders with a market capitalization of $439 million, has been making significant strides in the epilepsy ...

While the guidance does not provide specifics on how these risk analysis programs and documentation or monitoring could differ from traditional devices, FDA notes that details on the submitter’s ...

When looking at the evidence of effectiveness of new treatments, our independent committees look at the long-term effects on health that a drug might have ... of the drugs or devices they are ...

So here are the headlines: • When planning a clinical trial: if you are responsible for your company’s or institution’s policy on reporting ... worked with the US FDA devices division ...

When the efficiency of a drug, medical device, or intervention is the outcome ... of utmost importance are included in the case report form (CRF). It is advisable to exclude from the CRF ...

The FDA alerts healthcare providers that certain patient monitors from Contec and Epsimed are gathering data and beaming it to a hardcoded IP address.

According to the recent results stemming from a 4-year analysis, FDA officials are bringing forth warning letters at increasingly higher rates year over year since 2020 for both pharmaceutical and ...

About one-third (32%) of trials reported an independent DMC, while 6% reported blinded interim analysis. We found that 9% of adaptive ... clinical or both); intervention type (drug, medical device or ...

The Food and Drug Administration Feb. 5 released an alert notifying patients of a safety concern using diabetes devices such ...