The Health and Human Services Office of Inspector General has found that, in a few cases, FDA officials veered from the accelerated approval pathway.

The FDA’s Webinar for Manufacturers and Other Interested Parties - The U.S. Food and Drug Administration (FDA) will host a webinar ...

The FDA has previously issued warnings about unauthorized wearables claiming to measure blood glucose levels, so it's super ...

In the United States, the biomedical industry encounters numerous regulatory challenges in conducting nonclinical and ...

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 ...

Two top clinicians have been disciplined amid growing concern that Kaiser’s system for monitoring research safety and ethics ...

The most common approval process for clinical trials using unapproved ... The Pharmaceuticals and Medical Device Agency (PMDA) offers consultation before clinical trial notification (CTN ...

Be that as it may, sectors like health IT, telemedicine and digital health platforms are witnessing growth opportunities and a positive outlook. Here, we have picked four Medtech stocks that are set ...

With continued investment and growing buzz from the industry, the AI hype is expected to extend through 2025 and beyond.

RenovoRx, Inc. ("RenovoRx" or the "Company") , a life sciences company developing novel targeted oncology therapies and commercializing RenovoCath®, a novel, FDA-cleared delivery platform, today ...

Getting FDA approval was a long process – an earlier, bulkier version of the device was first submitted back in 2016 – but the company now intends to start shipping its first devices in the US ...