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

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.

Future Of 340B Rebate Models Hinges On Regulatory Decision Point

 
• By Ed Silverman

As pharmaceutical companies seek to transform how drug discounts are delivered under the 340B program, a federal ruling reinforces HRSA's authority. The industry must now wait for critical guidance from the Trump administration that could reshape compliance strategies and financial outcomes.

Digital Transformation At The FDA: Generative AI Set To Transform Drug Review Process

 
• By David Wild

The FDA plans to implement generative AI for drug reviews by 30 June 2025, enhancing efficiency and potentially accelerating approval processes. Discussions with OpenAI about AI integration are ongoing.

More from In Vivo

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.

Medtech Innovators Court London-Based Investors At BioWales 2025

 
• By Ashley Yeo

BioWales in London 2025 showcased the efforts healthtech innovators are making to meet investors on their own turf, illustrating changing attitudes and evolving needs.

Rising Leaders 2025: Metsera’s Whit Bernard’s Musical Path To Biotech Leadership

 
• By David Wild

Metsera CEO Whit Bernard applies an unconventional leadership philosophy to develop next-generation obesity therapeutics, including monthly GLP-1 injections and oral peptides.