FDA Putting Methods in Place for 3-D Printers

medical devices

Three-dimensional (3-D) printers are kinda changing the world. It used to be that if you wanted something, you had to go to the store to buy it. But with 3-D printers you can just make it. The machine takes a digital design and then sprays or squeezes a polymer material onto a platform and adds […]

FDA Wants Data on Defibrillator Devices

defibrillator leads

The U.S. Food and Drug Administration (FDA) has ordered a medical technology company to understand the cause and extent of failures of its heart-device components that have been linked to as many as 20 deaths. FDA says that St. Jude Medical needs to conduct studies to find out why its Riata defibrillator leads, which were […]

Medical Device Industry Wants FDA to Change

Venture capitalists, companies, and lobbyists are beginning to apply a lot of pressure to the U.S. Food and Drug Administration (FDA) to change the way it handles medical device applications. They argue the FDA’s handling of medical devices is stifling innovation in the U.S. As reported by Luke Timmerman in a Xconomy.com article that got […]

GAO Concerned About Medical Device Approval Process

GAO has raised concerns about FDA's review of high-risk medical devices

The Government Accountability Office (GAO) has raised concerns about the approval process that high-risk medical devices undergo — or rather, don’t undergo — by the U.S. Food and Drug Administration (FDA). The federal watchdog group says the agency recently took steps to see if certain high-risk medical devices, such as artificial hips and external defibrillators, […]