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/