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Wednesday, October 7, 2026

Author

Oliver Strnad

Oliver Strnad covers devices and medtech for Dark Biotechnology: clearances, approvals and specifications from makers' documentation, with limits stated as limits.

Articles by Oliver Strnad

A product engineer reviewing a regulated software build on a widescreen display beside brushed-steel lab shelving in cool teal light.

Software as a Medical Device Explained: How FDA Regulates Standalone Clinical Software

Oliver Strnad

An engineer in lab coat and safety glasses inspects a device housing under cool white-teal light at a steel workbench.

How Medical Devices Get Reimbursed: The Medicare Coverage Pathway Explained

Oliver Strnad

An engineer in gloves examining a precision medical device assembly under cool white laboratory light.

How Medical Device Trials Are Designed Differently From Drug Trials

Oliver Strnad

A radiology researcher reviewing grayscale scan overlays on a monitor array beside a glass control console in cool blue light.

How Are AI-Enabled Medical Imaging Platforms Regulated by the FDA?

Oliver Strnad

A gloved researcher calibrating a small wearable biosensor against a brushed-steel instrument under cool teal lab lighting.

How Do Continuous Glucose Monitoring Devices Work and Reach the Market?

Oliver Strnad

A surgical team observes a robotic manipulator arm over an instrument tray in a steel-and-glass operating suite, cool white and teal light, no logos.

Surgical Robotics Explained: From PUMA 560 to the Modern Operating Room

Oliver Strnad