Diagnostic-Maker Scanadu Lands $35M As FDA Submission Nears

Scanadu, a Mountain View, CA-based startup that’s making a diagnostic device it likens to Star Trek’s famous Tricorders, has received $35 million of Series B funding led by a group of Asian investors as the company readies itself to seek regulatory approval later this year. The round could be a big step as Scanadu tries to make the leap from a crowdfunding sensation to a company able to make medical device worthy of FDA sanction.

Scanadu’s Scanner is a small device that when paired with a smartphone can take and save a number of vital signs. It’s small enough to fit in a pocket, and the company says it’s simple enough for home use by placing the scanner on a user’s forehead.

The company is gathering data from an investigational version of its device, which is currently undergoing a clinical study. When complete, that study will be examined by a third party, Scripps Research Institute in San Diego, and Scanadu expects to submit a commercial version of the device to the FDA for approval by the end of this year, according to founder and CEO Walter de Brouwer.

Scanadu will also seek approval in Asian markets such as China, Singapore, and Hong Kong that will have a “parallel pathway” to that of the U.S., de Brouwer said. He hopes to be negotiating with the FDA to gain market entry for Scanadu’s core product, called Scanadu Scout, by 2016.

Since its founding in 2010, the company has raised $49.7 million. The latest round was led by Fosun International and Tencent Holdings Limited, with participation from China Broadband Capital and Iglobe Partners of Singapore. Scanadu’s Series A investors Relay Ventures, Redmile Group, Ame Cloud Ventures, and Three Leaf Ventures, an affiliate of The Broe Group, also joined in the Series B round.

Scanadu sent the investigational version of its device to some 8,000 people who backed an Indiegogo campaign that closed in 2013. Those who signed an informed consent document are participating in the study.

Scanadu’s diagnostic uses a single scan to measure a person’s heart rate, core body temperature, blood oxygenation, and cuffless- and calibration-free systolic and diastolic blood pressure in seconds, as Xconomy noted in a profile of the company in 2013. The device connects with an app on Android or iPhone systems, where it calibrates, analyzes, and stores a patient’s health information. The patient can then share it with a physician or family.

The scanner uses light to make electrocardiogram (ECG) and plethysmogram (PPG) readings. ECG’s are the well-known tests that measure electrical activity in the heart, while PPG’s can be used to measure volume of different parts of the body, such as blood or air in your lungs. A patient places the device on his or her forehead to take measurements, which are then converted into data that the tool analyzes.

“If you think of how we are going to make a new conversation with our doctors, it is because we are going to have the tools to measure ourselves and ask our doctors for interpretation,” de Brouwer said. “We will have to do that in real time. No one is going to send an e-mail to this doctor asking if he had a stroke, and wait three days until this guy reads an e-mail.”

Scanadu is also developing a similar at-home urine analysis test.

David Holley is Xconomy's national correspondent based in Austin, TX. You can reach him at [email protected] Follow @xconholley

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