Lesson 01
Incomplete
Types of Diagnostics: Labs, Imaging, Point-of-Care, and Digital Health
The word 'diagnostic' covers four fundamentally different businesses with different regulatory paths, cost structures, and buyer relationships.
Open lesson →Biotech
Diagnostics & Medical Devices
Understand the path from clinical insight to cleared product so you can navigate regulation, reimbursement, and market access without losing years to avoidable mistakes.
4 lessons · 52 minutes · Beginner
Lesson 02
Incomplete
Medical Device Classification and the Regulatory Pathway
FDA classification is not a bureaucratic formality — it determines how much evidence you need, how long it takes, and how much it costs to reach the market.
Open lesson →Lesson 03
Incomplete
Clinical Validation vs. Clinical Evidence: What Payers and Hospitals Actually Require
Regulatory clearance proves a device is safe and effective enough to sell. Clinical evidence proves it is worth buying — and those are different questions with different answers.
Open lesson →Lesson 04
Incomplete
Reimbursement Strategy for Diagnostics: CPT Codes, LDTs, and Coverage Decisions
A cleared diagnostic without a reimbursement pathway is a science project with a regulatory stamp on it.
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