irrelevant now what regulations say because device is CE marked after all- but doesn’t negate basic point that there’s a fair amount uncertain about its efficacy. I’m now more interested to see
1. what their latest trial data looks like because it’s overdue an update
2. the device’s package insert /product information approved by BSI which can give a good idea of the type of language about device the regulator permitted , but conspicuously absent from OSL website.
3. what were commitments made about PMCF, e.g is simple registry sufficient or something more?? OSL comms silent on that.
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