1. In Vivo
  2. >>Market Access

Into 2019: Digital Leads US Policy Innovations, But Public Medtech Scrutiny Grows

 
• By David Filmore

Scott Gottlieb's FDA continues to push out policy reforms and experiments at a rapid pace, with special focus on digital and AI technologies. In parallel, US Medicare officials are more publicly signaling plans to roll out policies for a quicker path to reimbursement for new devices. However, public scrutiny of whether device regulations properly protect patient safety is growing, and it could have an impact. 

Artificial intelligence (AI) technology moved squarely into the clinic in 2018 with multiple US Food and Drug Administration approvals and clearances throughout the year. In addition, the agency approved its first high-profile consumer mobile apps in 2018, with the Apple Watch ECG apps and another company's contraceptive app.

On top of these product-by-product advances, the FDA moved toward a launch of an experimental "pre-certification" approach to digital health...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on In Vivo for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Market Access

Global Pharma Interest In Korea Undeterred Despite Political Roller Coaster

 
• By Jung Won Shin

Despite recent political turmoil, outside investor and corporate interest in South Korean biopharma innovation appears robust or even increasing.

Podcast: ADDF’s Karen Harris On Investing In Alzheimer’s Like A VC

 
• By David Wild

A discussion with Karen Harris, CFO of the Alzheimer's Drug Discovery Foundation, about the foundation's investment strategy, biotech and investor sentiment at the recent BIO conference and what innovations give her hope for Alzheimer's patients.

Wide Of The Mark: ‘The Worst EU Medtech Predictions Have Not Come True’

 
• By Ashley Yeo

Jana Grieb, European regulatory and market access legal expert at McDermott Will & Emery, explains why the healthtech and pharma industries are warming to the new EU health commissioner as he faces calls to make the MDR more “user friendly.”

Crisis Or Opportunity? US MFN Policy Could Test Japan’s Appetite For Reforms

 
• By Lisa Takagi

While the adoption of most favored nation drug pricing in the US stands to affect Japanese biopharma firms now heavily reliant on this market, it might also present an opportunity for pricing and policy reforms at home.

More from In Vivo

Deals In Depth: June 2025

 
• By Deanna Kamienski and Maureen Riordan

Five $1bn+ alliances were penned in June, and four exceeded $2bn.

Global Pharma Interest In Korea Undeterred Despite Political Roller Coaster

 
• By Jung Won Shin

Despite recent political turmoil, outside investor and corporate interest in South Korean biopharma innovation appears robust or even increasing.

Podcast: Oxolife’s Agnés Arbat, Winner Of The European Prize For Women Innovators

 
• By Jo Shorthouse

Agnès Arbat, CEO of Oxolife and winner of the EU Women Innovators Prize, joins In Vivo to discuss OXO-001, a novel non-hormonal treatment aimed at improving embryo implantation in IVF. She shares insights from her biotech journey and the future of fertility innovation.