Fitbit Continues its Race into Medtech with New EUA

Fitbit is continuing its rapid trajectory into the medtech industry with a new Emergency Use Authorization from FDA. The San Francisco, CA-based company said the EUA is for a low-cost emergency ventilator to help address patients’ needs during the COVID-19 pandemic. The company said after seeing the need for ventilators, it applied its deep in-house expertise in advanced sensor development and hardware design to quickly create Fitbit Flow, an automatic resuscitator inspired by the MIT E-Vent Design Toolbox and based on specifications for Rapidly Manufactured Ventilation Systems. Fitbit said during development and testing it consulted with Oregon Health & Science University emergency medicine clinicians caring for COVID-19 patients at OHSU Hospital and worked with the Mass General Brigham Center for COVID Innovation< working group on the design to meet the needs of practitioners. The firm said the ventilator 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. “COVID-19 has challenged all of us to push the boundaries of innovation and creativity, and use everything at our disposal to more rapidly develop products that support patients and the health care systems caring for them,” James Park, co-founder and CEO of Fitbit, said in a release. “We saw an opport...
Source: MDDI - Category: Medical Devices Tags: COVID-19 Business Source Type: news