Insight Accelerator Labs Member Receives FDA 510(k) Clearance

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Startup PhysIQ Successfully Overcomes Leading Hurdle on the Path to Commercialization

Insight Product Development
Without question, FDA clearance is one of the most significant hurdles to overcome, and we’re excited to see PhysIQ reach this major development milestone on their clear path to commercialization.

The focused technology development efforts of Insight Accelerator Labs member PhysIQ were recently rewarded with FDA 510(k) clearance for the company’s personalized physiology analytics system. The startup’s technology, which has been categorized as a Class II device for patient monitoring by the FDA, analyzes a user’s physiological data - including heart rate, respiration rate, oximetry, and blood pressure - to create a personalized baseline for each user and identify exacerbations earlier.

“Without question, FDA clearance is one of the most significant hurdles to overcome, and we’re excited to see PhysIQ reach this major development milestone on their clear path to commercialization,” says Steve McPhilliamy, partner at Insight Product Development, and executive director of Insight Accelerator Labs.

PhysIQ is actively building its platform for any organization that is aggregating biometrics from different devices. The company has already partnered with Samsung on SAMI, a platform Samsung created to collect data from various devices, and with the Scripps Translational Science Institute (STSI) to create a program that uses health sensors to improve the health outcomes of Ebola patients. In 2014 the company raised $4.6 million in a round led by LionBird.

To learn more about Insight Accelerator Labs and its process for helping startups advance their technologies toward commercialization, visit http://www.insightpd.com/accelerator/insight-accelerator-labs/ or contact Steve McPhilliamy at smcphilliamy(at)insightpd.com.

About Insight Product Development
Insight is a design innovation consultancy that uncovers innovation opportunities for clients, designs the technologies and experiences that support them, and drives their development through commercialization. Headquartered in Chicago, our award-winning innovations span dozens of industries, reach more than 30 countries, have earned hundreds of patents, and favorably impacted millions. Our work is informed by a decades-long product development heritage serving highly regulated industries with the most exacting standards. Insight culture allows our multi-discipline team to work as an agile unit to consistently deliver better business outcomes for clients. For more information visit http://www.insightpd.com

About Insight Accelerator Labs
Insight Accelerator Labs (IAL) is the first medical device accelerator in the Midwestern United States, and was launched by Insight Product Development in early 2013 with three distinct goals: to help drive innovation and business growth, fuel the momentum of Chicago’s health tech start-up ecosystem, and improve people’s lives by advancing meaningful technology toward commercialization. For up to 18 months, IAL member startups receive expert mentoring, product development services from one of the most experienced development teams in the world, grant and award application assistance and extensive infrastructure support to translate their technology into commercial success. For more information, visit http://www.insightpd.com/insight-labs

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Noelle Kull
Insight Product Development
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