The same month, Edwards stepped into a Medicare rule that took Abbott two years to win. The difference between them comes down to three decisions the FDA doesn't make
inside Paradromics' Connexus: how the hardware works, what the first patient result shows so far, and what it takes to get from one implant to a device Medicare will pay for
what your registration and your CE mark actually buy, the reimbursement wall that decides the market, and the China and EU playbooks, with Luca Buzzotta
where the money hides in a factory that scaled too fast, from the engineer who found it
the parts list is the easy part; FDA wants to know whether the holes can be exploited, and how you patch a device that stays in service for a decade
the high-risk rules for AI inside CE-marked devices just slid to 2028, but the transparency rules land August 2 and a second clock starts in September
the BioZorb recall and the resorption testing that missed it
Make your diligence boring before a buyer makes it expensive
Most companies building them will fail on the engineering
because clearance is not adoption, and adoption is not revenue
60% of the money is in the blades, not the robot
your BOM is 25% more expensive and the fix takes 18 months
