The FDA says the device, designed to repair broken blood vessels to stem bleeding, showed a “clinically meaningful benefit.” ...

According to the FDA’s public database, since the start of this year, the agency has issued only two de novo medical device ...

The agency OK’d an artificial vessel to restore blood flow in patients, even though its own scientists flagged questionable ...

The U.S. Food and Drug Administration (FDA) has announced a series of critical updates this week, reflecting its ongoing commitment to advancing public health and medical safety.

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 ...

Insightec: "I was discharged in 1999, at the height of the dot-com boom. The Israeli high-tech scene was dominated by names ...

Long story short, no LED light therapy beauty devices on the market are FDA-approved. The government agency requires an extensive and rigorous five-step process that includes laboratory research ...

Long story short, no LED light therapy beauty devices on the market are FDA-approved. The government agency requires an extensive and rigorous five-step process that includes laboratory research ...

The process of diagnosing colorectal cancer ... a necessary step in meeting regulatory requirements for medical device approval. They used a robotically controlled external permanent magnet ...

Switzerland is working toward reestablishing its relationship with the EU while exploring new avenues. Meanwhile, the U.K. is ...

According to the FDA approval letter, Aveva was the first applicant ... Topicals, Biologicals, Drug Devices, Soft Gels, Solid Orals & Suspensions. The largest survey yet to examine seriously ...

A 1992 law called the Prescription Drug User Fee Act was primarily intended to fast-track the time between applying for approval and ... fee programs for medical devices, generic drugs, biosimilar ...