Office Hours: Does My Software Need FDA Clearance (SAMD)?

On this edition of #HCBiz Office Hours, Don and Shahid talk with Yuma Nambu, Chief Strategy Officer (CSO) at CROSS SYNC. CROSS SYNC is a Japanese startup whose medical data analytics software, “iBSEN”, enables hospital ICU’s to automate the monitoring of patient vitals and motions continuously to assist healthcare professionals in identifying acute deterioration as early as possible.  The platform relies on multimodal AI capabilities that combine time-series vital analytics from physiological monitors and patients’ motion analytics from live video feeds including facial recognition and motion detection.  As CROSS SYNC looks to expand globally, and into the U.S. market in particular, what are the regulatory requirements for their software? Will they need FDA SAMD Clearance to deploy iBSEN in the U.S? Don, Shahid, and Yuma discuss FDA/SAMD regulatory requirements in detail. Plus, they expand on the idea to explore the more important question all digital health startups face: How will you prove that your software works?  For more details and full show notes: https://thehcbiz.com/171-office-hours-does-my-software-need-fda-samd-clearance/   The #HCBiz Show! is produced by Glide Health IT, LLC in partnership with Netspective Media.