Category: FDA Updates

FDA Updates

Medtronic Stent Graft Recall Is Serious

Medtronic has recalled the Valiant Navion thoracic stent graft system due to stent fractures and endoleak concerns. But the FDA has categorized the recall as Class 1, the most critical kind.

FDA Updates

FDA Clears Baxter AK 98 Dialysis Machine

AK 98 offers encrypted, two-way connectivity, which enables the system to pull prescriptions directly from the EMR for simplified workflow and data handling.

FDA Updates

FDA Appointment Signals Increased Attention on Medical Device Cybersecurity

Many see the FDA’s appointment of Kevin Fu as the first Director of Medical Device Cybersecurity as an indication that the agency will make medical device cybersecurity a priority this year.

Clearances

FDA Clears BioSerenity EEG Wearable Device System

The Neuronaute EEG System and IceCap EEG wearable device will allow physicians to remotely monitor and assess electrical brain activity of people living with epilepsy.

Recalls

FDA 2020 Recall Roundup: A Rough Year for Infusion Pumps

Infusion pumps or their components account for nine entries in the FDA’s list of 2020 medical device recalls.

Labeling

Ready for the UDI Enforcement Deadline?

If your company produces medical or health-related products, you need to know whether they meet the FDA’s definition of Class I medical devices—and, if so, you need to start now to implement UDI Rule requirements before enforcement begins on September 24.

Draft Guidances

FDA Issues Draft Guidance on Electromagnetic Compatibility of Medical Devices

FDA has issued draft guidance outlining information that should be included in pre-market submissions to demonstrate electromagnetic compatibility for electrically powered medical devices and medical devices with electrical or electronic functions.