Recently a founder tells me the submission is still months out, And I ask what the team will be doing
The global regulatory landscape for Software as a Medical Device (SaMD) has reached a definitive inflection point as of March
Scroll through any regulatory forum right now and you’ll find the same fight: is this feature Class I or Class
Preventive health is having its moment.
Full-body MRI. Genetic risk profiling. AI-assisted vascular analysis. Multi-cancer early detection. All of it
I Spent the Last Week Reading Everything I Could Find on Abbott’s Libre Duo. Here Is What Genuinely Impressed Me
Let me ask you something uncomfortable….
When was the last time a regulatory submission was rejected because the threat model
