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 opportunity to rally our expertise in advanced sensor development, manufacturing, and our global supply chain to address the critical and ongoing need for ventilators and help make a difference in the global fight against this virus.”
The EUA is about a month removed from Fitbit launching a large-scale study to validate the use of its wearable technology to identify atrial fibrillation in patients. This isn’t the only evidence of the company pushing further into healthcare.
In 2017, Fitbit stepped into the diabetes arena through a collaboration with DexCom. The collaboration allowed San Diego, CA-based DexCom to add its continuous glucose monitoring (CGM) data to the Ionic smartwatch.
And about two years ago, the tech company acquired Twine Health, a firm that developed a platform aimed at lowering healthcare costs.
The connected health platform is designed to help people manage chronic conditions, aid in lifestyle interventions like weight loss and smoking cessation and make it easier for providers and patients to collaborate on health plans.
Fitbit is in the middle of being acquired by Google. The $2.1 billion deal was announced in November of 2019 but has stalled because it has come under fire by the Department of Justice, according to an article from The New York Post. Critics of the deal said it could pose increased threats to customer privacy, The Post reports.