FDA Watch: What Labs Need to Know About New Medical Device Cybersecurity Rules
As of October 1, medical device makers must include information about their products’ vulnerabilities when seeking premarket authorization.
As of October 1, medical device makers must include information about their products’ vulnerabilities when seeking premarket authorization.
More multiplex COVID-19 combination tests emerge from premarket authorization pipeline.
Centers for Medicare & Medicaid Services proposes TCET pathway to expedite Medicare Coverage of newly approved breakthrough devices.
New program aims to provide greater transparency on the recommended performance characteristics of such tests.
Key approvals announced in June represented important steps forward for the lab testing industry.