The company believes that the trial results are enough to submit a request for FDA marketing approval of its blood testing device.
Clal Biotechnology Industries has announced that Sight Diagnostics, in which it holds a 3.5% stake through Anatomy, its fund for investment in medical devices, has completed a successful clinical trial for its device. Sight Diagnostics has developed a real-time blood test requiring only a few drops of blood that can be collected by pricking a finger. The company believes that the trial results will enable it to submit its product to the US Food and Drug Administration (FDA) for marketing approval.
Sight Diagnostics gave no timetable for submitting its request or obtaining approval. The product is already being marketed in Europe and Israel. Sight Diagnostics was founded in 2010 by former Mobileye project manager Yossi Pollak. The company raised $28 million last December.
Published by Globes, Israel business news – en.globes.co.il – on April 11, 2019
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Sheba Medical Center Photo; Bar El