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Micro Interventional Devices Inc.

www.microinterventional.com

Latest From Micro Interventional Devices Inc.

FDA Formally Classifies Cardiac Surgery Device, Robotic Arm

Both an arm prosthesis and a device used in transcatheter valve replacement will be regulated via class II, FDA announced this week.

Policy & Regulation Regulation

US Approvals Analysis: July A Good Month For PMAs; 510(k)s Down In 2016

A look at Medtech Insight's Approval Tracker data shows that last month was a relatively active one for US FDA approvals of novel devices via the PMA, panel-track supplement and de novo routes. But 510(k) clearance totals are down so far in 2016 compared to recent years.

Research & Development Regulation

Transcatheter Mitral Valve Therapy: Opportunities And Challenges

Amid the clinical and commercial success of transcatheter aortic valve replacement (TAVR), companies are preparing for what is predicted to be an even larger market in minimally invasive mitral valve replacement and repair technologies; in the summer of 2015, strategics made huge bets in quick succession on promising replacement valves. There is a great deal of activity on the repair side, too, and debate is ongoing about technical and regulatory challenges and which technologies are likely to be appropriate for patients with various types of mitral valve regurgitation.

Medical Device Innovation

Micro Interventional Devices’ Permaseal Moves Closer To Regulatory Approval With Early CE Trial Results

Preliminary 30-day results from the Secure Transapical Access and Closure Study (STASIS) suggest Micro Interventional Devices’ Permaseal device, a transapical access and closure device for structural heart repair, provides safe and effective hemostasis and wound closure after transapical transcatheter aortic valve replacement. The company estimates the worldwide market potential for the device is more than $3 billion annually.

Medical Device Innovation
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Company Information

  • Industry
  • Medical Devices
    • Implantable Devices
    • Surgical Equipment & Devices
      • Minimally or Less Invasive
  • Therapeutic Areas
  • Cardiovascular
  • Alias(es)
  • Ownership
  • Private
  • Headquarters
  • Worldwide
    • North America
      • USA
  • Parent & Subsidiaries
  • Micro Interventional Devices Inc.
  • Senior Management
  • Michael P Whitman, Pres. & CEO
    Willard Hennemann, PhD, CSO
    Linda Morgan, SVP, Operations
  • Contact Info
  • Micro Interventional Devices Inc.
    Phone: (215) 600-1270
    5 Caufield Pl.
    Ste. 102
    Newtown, PA 18940
    USA
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