The FDA today issued a notice informing customers of updated instructions for the Johnson & Johnson Abiomed Impella RP heart ...

FDA-Cleared Nanotechnology developed by Nanovis is planned for use to enhance Medtronic PEEK interbody fusion devices used in ...

QuantalX Neuroscience has gained the European CE Medical Device Regulation (MDR) approval for the Delphi-MD, a device for assessing brain health. With this certification in place, the company is ...

Maple Grove-based Morari Medical’s device “MOR” is a drug- and chemical-free approach for the common men’s sexual health ...

According to the CDC, more than 38 million Americans have diabetes. This warning is for people who use diabetes apps like continuous glucose monitors, insulin pumps, and other diabetes management ...

Many consumer devices undergo the FDA clearance process, such as LED masks and fitness trackers that have features like ...

Last week, the U.S. Cybersecurity and Infrastructure Security Agency (“CISA”) and the U.S. Food and Drug Administration (“FDA”) released ...

The FDA has issued a safety communication regarding the potential for missed alerts with diabetes devices due to software or hardware changes.

(HealthDay News) — The US Food and Drug Administration is urging all patients with smartphone-compatible diabetes devices to ...

The future of medical devices has much potential, but they also have risks related to cybersecurity. In 2024, we saw the first full year of the Food and Drug Administration’s (FDA) new guidance ...