What if a single moment of intuition could save a newborn’s life? In this episode of Inside MedTech Innovation, I sit down with Annamarie Saarinen, co-founder and CEO of Bloom Standard, to explore how a deeply personal medical emergency turned into a global mission to revolutionize pediatric diagnostics.
Annamarie shares the remarkable story of her daughter’s near-missed heart defect, and how a chance encounter with a visiting echo tech led to a lifesaving diagnosis. That experience revealed a massive gap in pediatric care: access to ultrasound, particularly in the hands of providers who aren’t trained specialists.
Bloom Standard is tackling that gap by developing the world’s first self-driving ultrasound system designed for babies and young children. Using AI and automation, their device brings diagnostic-grade imaging to the frontlines of care, empowering clinicians anywhere in the world to detect critical conditions early, accurately, and affordably.
We talk about:
The birth of Bloom Standard, and how trauma became transformation
The difference between adult and pediatric cardiology, and why so many babies go undiagnosed
What it takes to build a hardware + software + AI company in MedTech
The Total Product Lifecycle Advisory Program (TAP) at FDA and how early regulatory collaboration is helping Bloom scale faster
How Annamarie’s earlier policy work led to universal pulse oximetry screening in newborns, a change that reshaped care nationwide
00:03:00 – The story of Eve: when a murmur saved a life
00:07:00 – Why pediatric ultrasound isn’t standard—yet
00:13:00 – What makes pediatric cardiology uniquely complex
00:21:00 – Hardware, software, AI—and the hard path to MedTech
00:30:00 – The public health victory behind CCHD screening
00:39:00 – The trauma and cost of medical transport
00:42:00 – Building ethical, safe, clinically relevant AI
00:46:00 – How regulatory policy (TAP) is shaping Bloom’s future
Follow Shannon and Annamarie:
Connect with Shannon:
LinkedIn: https://www.linkedin.com/in/shannonlantzy
Website: https://www.shannonlantzy.com
Connect with Annamarie:
LinkedIn: https://www.linkedin.com/in/annamariesaarinen/
Website: https://www.bloomstandard.com/
