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Top 10 Device and Diagnostic FDA Approvals


We ran across this article in Fierce Medical Devices and thought we would share it.  The articleTop 10 Device and Diagnostic FDA Approvals highlights the Top 10 device and diagnostic approvals for 2012.  Every year companies submit their Premarket Approval Application (PMA), the application submitted to the FDA for approval of a Class III device, to FDA seeking premarket approval.  This application can sometimes prompt FDA to inspect clinical sites, but ultimately the hope for a sponsor is approval.

Failure to secure approval can be devastating to a company, impacting stock prices and in some cases lead to investors fleeing. Clearly the stakes are very high for a medical device company, so the companies listed on the list below, surely had a lot to celebrate.

  1. Boston Scientific’s S-ICD
  2. Cook Medical’s Zilver PTX
  3. Dune Medical Devices’ MarginProbe
  4. Glaukos iStent
  5. Globus Medical’s Secure-C
  6. HeartWave’s Ventricular Assist System
  7. Medtronic’s Arctic Font Advance
  8. OraSure’s OraQuick
  9. Qiagen’s KRAS RCQ PCR Kit
  10. U-Systems’ somo●v

An FDA approval can lead startup companies on the path to success or provide a much needed technology to the market. How prepared are you for approval? Waiting for decisions from FDA or other regulatory bodies can be worrisome. Eliminate the worry by being prepared. Going through a “mock” audit before an FDA audit takes place can help ensure you have the highest probability of earning favorable outcomes.

The article calls the FDA the kingmaker in the medical device and diagnostic industries.  Do you agree with this assessment?  Do you agree with the list?  Share your thoughts below.

Photo Credit: striatic


we are a company specialized in the manufacturing of cardiology interventional surgical disposables, we have been in this industry for a decade, all our products are CE&ISO certified, and we are under the way for a FDA approval now. I do think the 510K is very important for the success for a medical device company.
Posted @ Saturday, February 16, 2013 1:25 AM by Tina Zhou
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