5/20/19

The Rock Weekly

What the FDA wants you to know about Pre-Cert

It’s been a busy month for digital health over at the FDA. In addition to a warning for patients hacking insulin pumps, the agency issued a handful of clearances—from AliveCor’s six-lead smartphone ECG to two AI tools to make radiologists’ jobs easier.

The increase in approval for AI products is no coincidence—the FDA is evolving its oversight approach, and wants to do so in partnership with innovators. In our newest podcast episode, we caught up with the FDA’s Bakul Patel and portfolio company Enzyme’s Jared Seehafer to get an update on Pre-Cert and how the digital health community can provide input on the agency’s proposed framework for regulating AI/ML in healthcare. Learn more and listen here.

Headlines

Coming Soon: Express Script's Digital Health Formulary
Selection will vet for safety, effectiveness, usability, and cost savings FierceHealthcare | (Tweet)

Patterns In Capital Concentration Among Digital Health Startups
A look at how digital health VC compares to venture capital at large Rock Health Research | (Tweet)

Alphabet Wants To Protect People From Heart Disease
Verily and GV are backing a venture with a futuristic vision for treatment CNBC | (Tweet)

Why Walmart Is Steering Workers To High-Quality Imaging Centers
The nation’s largest employer is tackling expensive misdiagnoses Kaier Health News | (Tweet)

The Study Backing This Fertility Tracker's Claims Was Just Retracted
Whoopsie Daysy BuzzFeedNews | (Tweet)

JP Morgan Shelled Out $500M For A Medical Payments Tech Firm
It’ll be an unusual entry into the healthcare system for a bank CNBC | (Tweet)

UPMC Spins Out Infectious Disease Telemedicine Company
It connects specialists with rural community hospitals Modern Healthcare | (Tweet)

Rock Health In The News

Spire Health Is Launching A COPD Study
The Health Tag will provide continuous respiratory monitoring MobiHealthNews

The VA Is Tapping Virta Health For Remote Diabetes Treatment
+ A look at why Virta made CNBC’s Disruptor 50 list Health Data Management

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