Clearances & coverage — the full backbone
FDA-cleared, CE-marked, CMS-covered, ASAPS-endorsed — and each has its own page.
Four independent signals
SofPulse rests on four separate forms of validation, each from a different body and each detailed on its own page in this library: the US FDA clearance, the European CE mark, US Medicare coverage, and a clinical-society endorsement. They are independent — a regulator clearing a device for safety and efficacy is a different bar than a payer agreeing to cover it.
Why the stack matters
Any one of these alone is partial. Together — cleared to sell, marked for Europe, covered for payment, and endorsed by the surgeons who use it — they form a backbone that is hard for a competitor without the same history to assemble.
What this means for prescribers
An FDA-cleared, CMS-covered device sits in a different conversation than an investigational or wellness-grade product. Prescribers can order it, document it, and refer patients to it without navigating off-label terrain. The RTM billing codes that generate practice revenue are available because the device is cleared and covered — without the regulatory backbone, the billing codes are inaccessible. The full regulatory stack is what enables the entire clinical and commercial case for integration into a surgical or wound-care practice.
What this means for patients
For a patient, FDA clearance means the device has been evaluated for safety and efficacy by the same agency that evaluates drugs. CMS coverage means Medicare will pay for it in chronic wound care. ASAPS endorsement means the surgeons who use it in their own practices have formally recognized it. These signals, taken together, answer the question patients are implicitly asking: 'Is this real, and is it for me?' The answer the regulatory stack provides is yes on both counts, within defined and clearly stated boundaries.
Sources
- FDA 510(k), Dec 2008
- CE Mark Class IIa
- CMS NCD 270.1
- ASAPS
Related
Ready to put SofPulse to work?
SofPulse is available by prescription. Patients can order online and pay with pre-tax HSA/FSA dollars; clinicians can start prescribing in minutes.
For education only — not medical advice, and not a substitute for a clinician's judgment. SofPulse is available by prescription only. Reimbursement figures reflect the 2026 CMS Physician Fee Schedule and vary by locality, payer, and documentation.