FDA granted an emergency use authorization for the Fitbit Flow, a low-cost ventilator, for use during the COVID-19 pandemic. The company said the device builds on standard resuscitator bags, like those used by paramedics, with sophisticated instruments, sensors, and alarms that work together to support automated compressions and patient monitoring.
It's rare that the head of one of the industry's most prominent trade associations takes a stand on a controversial social issue, but as the father of a black son, Scott Whitaker said he just couldn't stay silent about the recent protests sparked by the murder of George Floyd in Minneapolis, MN. Whitaker penned an open letter to the medtech community, urging the industry to stand up, listen, and act on, "eradicating the disease of racism in this country and around the world."
Bigfoot Biomedical, the diabetes tech startup that wants to close the diabetes management loop, raised $55 million in a series C round led by its partner Abbott. The company is on track to file for FDA 510(k) clearance in 2020 to market the Bigfoot Unity System, part of a real-time, dose-decision support system for people with insulin-requiring diabetes who rely on multiple daily injection therapy.