U.S. Food and Drug Administration

This regulatory science tool (RST) is a computational method that employs conditional denoising diffusion probabilistic model (DDPM) to generate synthetic histopathology images guided by nuclei segmentation masks, helping to augment limited annotated whole slide image (WSI) datasets for AI model development and validation in digital pathology.

This regulatory science tool (RST) is a coupon designed for use in tensile testing additively manufactured lattices.

The tool provides hemolysis data obtained from inter-laboratory bench experiments within generic and simplified device geometries. Modelers can use the data to perform early-stage evaluation of their computational fluid dynamics (CFD) model of hemolysis.

This regulatory science tool presents a laboratory method to assess the mechanical integrity of anterior vertebral body tethering (AVBT) devices.

This regulatory science tool (RST) is a lab method for absolute vessel caliber and retinal blood flow velocity measurements in humans using a high-resolution (spatial and temporal) multimodal adaptive optics system with scanning laser ophthalmoscopy (SLO) and optical coherence tomography (OCT).

This regulatory science tool (RST) is an open-access dataset containing adaptive optics – optical coherence tomography (AO-OCT) images of the outer retina, along with the cell markings and topographical characterizations of the retinal pigment epithelium (RPE) cells and photoreceptor (PR) mosaics across the temporal macula from healthy individuals. This RST can serve as a normative baseline for future studies of retinal pathology and as labelled ground truth data for the assessment of novel algorithms for automated PR/RPE cell segmentation.

This regulatory science tool (RST) is a phantom that can be used for the assessment of certain fundamental performance parameters of adaptive optics (AO) imaging systems.

This regulatory science tool (RST) is computational material model of polyurethane bone foam with a density of 20 pounds per cubic foot (PCF), which can be implemented in a finite element analysis application.

This regulatory science tool (RST) is a quantitative optical coherence tomography angiography (qOCTA) method to measure the absolute velocity of individual blood cells within retinal microvasculature and map 3D flow rates.

A tool to assist with evaluating and quantifying contractile response of non-excitatory electrical stimulation signals including CCM in vitro using 2D human cardiomyocyte models