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? 


Yuma Nambu

An experienced health IT consultant and researcher with 5-years plus experience and skills in international development and technology industry. Currently, working for dual roles of the Chief Strategy Officer (CSO) at CROSS SYNC, a medical AI startup in Japan, and the researcher at Yokohama City University, School of Medicine. As the CSO, taking charge of overall business strategy, including research funding, licensing, IP, and internal and overseas business strategy, while leading R&D projects using patient image recognition for severity assessment AI and UI/UX design for the product. Prior to these roles, having worked on designing an IT architecture that contributes to the advancement of enterprise network and hospital systems and improving access to healthcare services in underserved areas in Japan and abroad especially LMICs through telemedicine at Cisco Systems and an international medical NGO. Graduated with honors in Risk focused on public health and infectious diseases epidemiology from Durham University in the UK.

CROSS SYNC

 CROSS SYNC is founded by Dr. Takaki (intensivist) with a passion to eliminate preventable deaths, motivated by his traumatic experience during medical residency. Our mission is to provide technologies that cover expertise in clinical environments, especially in intensive care units (ICU’s). Our medical data analytics software, “iBSEN”, enables hospital ICU’s to automate the monitoring of patient vitals and motions continuously to ensure healthcare professionals can provide high-quality care through real-time actionable intelligence, allowing more rapid response to acute deterioration. Our core competency derives from 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.

For more information:

How can The #HCBiz Show audience help?

  • Especially for research institutions, hospitals, and Med-tech/health-tech companies, we’re looking for more research opportunities abroad, so please contact me if you’re interested in our product, AI research, and even the concept of our business.
  • Research opportunities as in pilot research of our product including AI portions, clinical trials, and research partnership.
  • Also, we’re wishing to have more opportunities to talk to Health IT folks in US healthcare fields to assess our product-market fit in the US and find where to focus or appeal.

Follow-up with Yuma – Meeting Request (Calendly): https://calendly.com/yuna916/hcbiz-oh-followup

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