We ran across this article in Fierce Medical Devices and thought we would share it. The article 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.
- Boston Scientific’s S-ICD
- Cook Medical’s Zilver PTX
- Dune Medical Devices’ MarginProbe
- Glaukos iStent
- Globus Medical’s Secure-C
- HeartWave’s Ventricular Assist System
- Medtronic’s Arctic Font Advance
- OraSure’s OraQuick
- Qiagen’s KRAS RCQ PCR Kit
- 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.
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