Everything it takes to bring cancer technology to market — the FDA pathway builders, validation at the apex, and the investors who back it.
Pick the route that fits your device and assemble the submission step by step. Not sure which applies? Start with BDD to qualify the technology as new.
Four guided builders for the four FDA device pathways — from designation to approval.
Assemble a Breakthrough Device Designation request — qualify your technology as new and unlock expedited FDA review.
Open builderBuild a premarket notification — establish substantial equivalence to a legally marketed predicate device.
Open builderRequest a De Novo classification for a novel low-to-moderate-risk device with no predicate — creating a new device type.
Open builderCompile a premarket approval application — the clinical evidence of safety and effectiveness required for Class III devices.
Open builderA cleared device still needs the evidence the field trusts. Through PPS Exempt Consilium, technology is proven at the eleven PPS-exempt apex centers — then cascades through the NCCN network, NCI-designated centers, and the community hospitals that treat most patients.
The entry credential — built in the BDD Builder above.
The eleven cost-reimbursed centers generate the comparative evidence CMS now requires.
NTAP / RAPID pathways carry validated technology into adoption.
Emerging technology moving toward the clinic, split by track. Submit a candidate, or develop these into a live, curated pipeline.
Hardware, imaging, surgical, and diagnostic technology on a device pathway (BDD · 510(k) · De Novo · PMA).
Submit a device technologyTherapeutics and biologics — targeted agents, immunotherapies, ADCs, and cell therapies on a drug/biologic pathway.
Submit a therapeuticBack the technology proven at the apex. Request access, review the pipeline, and get in touch.
Introductions, thesis, and the model behind the pathway.
Request access to diligence materials and the deck.
See device and pharma candidates moving through the pathway.
Talk through the opportunity with the team.