News We’re Watching: Quest And CDC Partner On Hep C, Califf on Clinical Trials, Latest Recalls And Approvals

This week, Quest Diagnostics contracted with the CDC to research the public health impact of hepatitis C; FDA Commissioner Robert Califf published a blog post on clinical trial transparency; Dexcom and Abbott approached a deal in their CGM patent case; and SoClean, Cordis and Eitan all announced recalls.

Regulatory News We're Watching
• Source: Shutterstock

Quest Diagnostics Incorporated will partner with the US Centers for Disease Control and Prevention to study the impact of hepatitis C in the US, the company announced on 7 December.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight 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

More from Regulation

‘The FDA Will Be Looking For Avenues To Regulate Laboratory Developed Tests’

 

The FDA's final LDT ruling was struck down in federal court last month. For now, diagnostic companies can commercialize under CLIA regulations or apply for FDA approval. McDermott and Tribun Health have shared insights on the risks, pros and cons of both regulatory routes.

Update: Italy’s IMQ And Belgium’s SGS Named 15th and 16th IVDR Notified Bodies

 

Ireland’s NSAI reinstated under IVD Regulation designation list

Trump’s Preliminary 2026 HHS Budget Plan Protects US FDA User Fee Collection

 
• By 

The preliminary White House 2026 budget plan cuts agency funding, but not so sharply that user fees are excluded from collection.

Abbott, J&J Reaffirm 2025 Profit Guidance Despite Growing Tariff Uncertainties

 
• By 

Abbott and J&J reassured investors they will maintain their 2025 profit forecasts. Abbott projects $5.05 to $5.25 per share and plans a new $500m investment in manufacturing and R&D sites. J&J anticipates $400m in tariff-related costs but committed $55bn in US investment over four years.

More from Policy & Regulation

Keep An Eye On Landmark Global Pandemic Treaty, Experts Advise

 

Mechanisms in the draft treaty that the more than 190 member states of the World Health Organization have finally agreed to are expected to “materially affect companies,” particularly those that develop, manufacture or distribute pandemic-related health care products.

New Semiconductor Tariffs Could Raise Device Costs

 
• By 

Proposed tariffs on semiconductors from President Donald Trump could significantly raise costs for the US medical device industry. Current domestic production cannot meet demand, spurring concerns about potential price increases for consumers and healthcare systems.

AdvaMed Unveils Its First ‘AI Roadmap’ To Help Lawmakers Navigate Regulating The Technology Through Rocky Times

 

Members of AdvaMed’s digital health tech board of directors discussed the organization’s efforts to aid the Trump administration and Congress in answering AI policy questions, especially as companies deal with mounting regulatory uncertainty.