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It’s news because the regulatory approval is very different between the US and the EU. Being the first of a kind in the US means you go through a more in depth
by jtwaleson 3y ago
It’s news because the regulatory approval is very different between the US and the EU.
Being the first of a kind in the US means you go through a more in depth process with FDA (DeNovo). It’s a big achievement for the manufacturer. After that other manufacturers have it much easier to launch a similar product.
- jtwaleson 3y agoOh and also the FDA puts more emphasis on devices working for all Americans, so this company had to prove that it works on all skin colors. This might work better than in the German device.