Medical technology pioneer Forest Devices, Inc. (FDI), a medical device company focused on identifying patients with large vessel occlusive (LVO) strokes in the prehospital environment, today announced that the U.S. Food and Drug Administration (FDA) has designated its AlphaStroke technology as a Breakthrough Device.
“We are thrilled to work closely with the FDA to accelerate the introduction of what is currently the most needed intervention in for patients suffering a stroke,” said Matt Kesinger, CEO of FDI. “As a former EMT on ambulances, I experienced the challenge of correctly identifying stroke patients in the field. The AlphaStroke device is the only portable technology designed specifically to assist prehospital providers.”
The goal of the Breakthrough Device program is to provide patients and health care providers with timely access to certain medical devices that deliver more effective treatment of life-threatening or irreversibly debilitating diseases or conditions by speeding up their development, assessment, and review.
LVOs are the most debilitating type of stroke and require an interventional thrombectomy, only available at highly specialized hospitals. Every minute of treatment delay increases the risks of death and permanent disability.