Diagnostics and medtech.
A continuous glucose monitor is a wearable sensor that measures glucose in interstitial fluid around the clock and streams values to a smartphone app. The category hit a regulatory milestone on March 5, 2024, when FDA cleared Dexcom's Stelo as the first over-the-counter continuous glucose…
Surgical robotics is the use of computer-controlled manipulators, operated by a surgeon at a console, to position instruments and cameras inside the patient. The systems in clinical use are not autonomous: they act as fully controlled remote extensions of the surgeon, master-slave manipulators…
Wearable health devices are regulated by where their claims sit on a line FDA draws between lifestyle encouragement and disease-related intervention: general wellness products fall outside device regulation, while claims to detect or inform clinical management require a premarket pathway. The…
In vitro diagnostics are regulated as medical devices under different instruments in the US and EU: FDA classification and premarket review in America, and the dedicated European Regulation 2017/746 in Europe. The US boundary moved in 2025, when a federal court vacated the FDA's…
The FDA's Quality Management System Regulation took effect on February 2, 2026, replacing the Quality System Regulation that US device manufacturers have operated under since 1996. The new rule amends the device current good manufacturing practice requirements of 21 CFR Part 820 by incorporating…