1. In Vivo
  2. >>Market Access

Diagnostics 2018: Steady Progress And The Big Get Bigger

 
• By Mark Ratner

If the beginning of 2017 was marked by doubts around whether and how the FDA would act with respect to complex diagnostics, we enter 2018 feeling that slow-moving vessel may finally be turning.

2018-DX_IV1801_web-1200.gif

FDA product reviews were the lead story for the year, as Class II device designations emerged for large-panel tumor-profiling assays and direct-to-consumer (DTC) genetic health risk assessment (GHRA) tests.

In early November, the agency put forth its plan to regulate DTC GHRAs, exempting them from premarket review under certain...

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

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.

AI In Health Delivery: Patients Most Confident When HCPs Are In Charge

 
• By Ashley Yeo

Annual survey of patients and professionals shows how attitudes to health system transformation are evolving and what stakeholders are demanding as acceptance of AI tools accelerates.

US Health System Redesign Critical, NAM’s Medical Experts Warn Trump Government

 
• By Ashley Yeo

The whirlwind back-and-forth on US tariffs and Robert F. Kennedy jr.’s plans to deregulate health care have become all-preoccupying, but the National Academy of Medicine was first to set out President Trump’s health administration priorities.

More from In Vivo

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.”

This Belgian Biotech’s Drug Cocktail Could Help Reverse Muscle Aging

 
• By Jo Shorthouse

While big pharma pours billions into creating new anti-aging molecules, a Belgian startup has taken a different path: combining existing safe drugs with AI precision. The early results suggest it might be onto something revolutionary.

Rising Leaders 2025: Doxie Jordan, From UNC Graduate To Global Market Strategist

 
• By Jo Shorthouse

Bristol Myers Squibb executive Doxie Jordan discusses his path to global commercial leadership and the principles guiding pharmaceutical market strategy