A 30-year-old producer at CNET was losing weight fast, constantly thirsty, experiencing blurry vision. Two different doctors gave him metformin, a Type 2 diabetes drug, and sent him on his way. For six months, Justin Eastzer felt isolated, scared, and progressively worse. The doctors never ran the autoantibody test that would've revealed Type 1 diabetes. Then Justin made a TikTok video about a blood glucose meter that sent data to his phone via Bluetooth. He thought the tech

A software company was using Zendesk to track customer feedback. Every issue, from "can't log in" to actual product defects, was automatically categorized as a "complaint." Thousands of them. When Kyle Rose, president of Rook Quality Systems, showed up for their first internal audit, he found exactly what FDA reviewers would've found: a massive compliance gap that could've killed their regulatory submission. This wasn't a careless startup. This was a functioning medical devic

From 5G networks to space station surgery, exploring the invisible infrastructure that makes modern healthcare possible Remote surgery between continents. Glucose monitors competing with Netflix streams for wireless bandwidth. Surgical robots on the International Space Station. None of this is science fiction, it's the cutting edge of medical technology that Dr. Omar Al-Kalaa has been working to make safe, effective, and accessible. In this episode of Inside MedTech Innovati

The pain hit instantly. Dr. Jennifer Hackett had walked into hundreds of classrooms over her teaching career, but this newly renovated...

The year 2002 marked a turning point in cybersecurity history, though few realized it at the time. Microsoft was hemorrhaging customers...

The moment that changes everything isn't always dramatic. Sometimes it's a phone call. [00:11:00]  Lane Desborough was at work when his...

A conversation with Elina Ontiskansky on removing stigma, embracing personalization, and treating the whole human in obesity medicine...

Reflections from my conversation with Ed Gaudet, CEO of Censinet Listen to the episode on Spotify:   https://open.spotify.com/show/0idCT...

A conversation with Dr. Richard O'Neill on regulatory innovation, market optimization, and the challenges of implementing change in...

Nor would they want you to. Treat FDAers as humans, understand the context of your conversation, and remember your common goals....

The National Academies of Science released a publication on Cyber Hard Problems . I thought it would be about post-quantum cryptography,...

Matthew Holt on the Healthcare Status Quo, Data Access, and the Power Struggle Behind Digital Health “If you want to change the system,...

I am giving a talk and will use Sotagliflozin as a regulatory decision case study. I needed a quick summary of this regulatory decision...

In the age of deep fakes and the de-throning of science, trust is dead. Instead of asking what is trustworthy, I am asking: "What...

Every year, thousands of babies go home from the hospital with undiagnosed heart defects. Many look perfectly healthy—until it’s too...

In medical technology, we often focus on what devices do —the clinical functions they perform, the outcomes they enable, the hardware and...