1. Medtech Insight
  2. >>Policy & Regulation
  3. >>Regulation

Essure Update: Almost All Unsold Units Back To Bayer; Postmarket Study Enrollment Complete

 
• By Elizabeth Orr

The US FDA says Bayer has successfully recovered unsold Essure units and completed enrollment in a Sec. 522 postmarket study, fulfilling deadlines set at a year from the date the devices were taken off the US market.

ESS305 hand40v2 small
• Source: Bayer AG

One year after Bayer AGremoved its problem-prone Essure implantable birth control device from the US market, the company has retrieved almost all unused product units and completed enrollment in a postmarket study that was requested by the US Food and Drug Administration.

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
Start Free Trial

Already a subscriber?

More from Regulation

Italy’s IMQ Designated As 15th Notified Body For IVDs

 
• By Amanda Maxwell

Ireland’s NSAI reinstated under IVD Regulation designation list

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

 
• By Cathy Kelly

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 Marion Webb

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.

Notified Bodies Warn Of Hurdles In The Way Of Their AI Designations

 
• By Amanda Maxwell

Will challenges in the way of designations of notified bodies that assess AI-enabled medical devices create delays and bottlenecks and slow EU medtech innovation?

More from Policy & Regulation

Precision Neuroscience’s FDA Clearance For Core Component Of Brain Implant Expected to Accelerate R&D

 
• By Marion Webb

Precision’s recent FDA clearance for a core part of its next-generation wireless brain-computer interface system opens the pathway to a safer, more humane BCI for researchers to use compared to higher-risk intracortical arrays, according to BCI expert Naveen Rao.

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

 
• By Cathy Kelly

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 Marion Webb

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.