ScandiDos Obtains FDA 510(k) clearance for Delta4 Discover™ in U.S.

by Business Wire

UPPSALA, Sweden--()--ScandiDos announced today that Delta4 Discover™ received 510(k) clearance by the U.S. Food and Drug Administration, bringing to market the first device that independently verifies the radiation dose delivered to a patient during radiation treatment.

“Until now, the concept of measuring the daily dose of radiation in real time, to ensure it accurately matches the patient treatment plan, did not exist. Delta4 Discover will provide this critical step in the radiation process, enhancing patient safety,” commented ScandiDos CEO Görgen Nilsson. “It brings a new level of precision to dosimetry technology for cancer radiation therapy, and the FDA clearance paves the way for ScandiDos to make this new technology available to our U.S. customers.”

Delta4 Discover is an in-vivo dosimetry system that provides tools for the measurement of the radiation dose delivered during cancer radiation therapies. By independently verifying all dosage delivery parameters, it greatly increases the quality and overall safety of the most complex and demanding treatment methods. Delta4 Discover verifies Volumetric Modulated Arc Therapy (VMAT) or RapidArc® Radiotherapy Technology treatments on tumors and sets the stage for new treatment modalities, including adaptive radiation therapy. 

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