Some Cell-Counting Lasers Don’t Need Medical Review, FDA Says

Laser-based technology used in medical devices to gather information on living cells may avoid a common device review, the FDA announced March 5.

The move is intended to increase access to flow cytometry devices and reduce the number of reviews, which can take up to 100 days to complete, the Food and Drug Administration said in its proposed order. The tools are used to count cells, measure cell size, or see what the cell is made of.

The instruments that measure cell characteristics generally look for toxins and other foreign objects that help detect if cells are infected ...