Hardware Podcasts

Overcoming Barriers to Receiving 510(k) Clearance: One Company's Go-to-Market Triumph

Global Medical Device Podcast · 17 Feb 2022 · 34m · Episode 246

What this episode covers

Scott Anderson, Chief Clinical Officer at SyncThink, explains how the company uses its EYE-SYNC platform to objectively measure eye movements for neurological assessment, covering conditions like concussions, ADHD, and neurodegeneration. Anderson details the company's journey from Department of Defense-funded research to obtaining 510(k) clearance, highlighting the logistical challenges of tracking 10,000 subjects across multiple locations using retrofitted mobile testing units. He discusses the strategic decision to focus on specific indications like concussion and ADHD rather than 'boiling the ocean,' and predicts a future convergence between consumer wearables and regulated medical devices for proactive brain health monitoring.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
SyncThink, Greenlight Guru, Shire, Takeda, Priority Designs
Products
EYE-SYNC, Q collar, Apple Watch

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