Swedish dosimetry company ScandiDos said yesterday it won FDA 510(k) clearance for its Delta4 Discover device designed to verify radiation doses delivered to patients during radiation treatments.
The Delta4 Discover is designed as an in-vivo dosimetry system which independently verifies all dosage delivery parameters with the aim of increasing the quality and overall safety of radiation-based cancer treatment methods.
“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. 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,” CEO Görgen Nilsson said in a press release.
ScandiDos’ Delta4 Discover system verifies volumetric modulated arc therapy, or RapidArc radiotherapy treatments on tumors to allow for new treatment modalities, such as adaptive radiation therapy, the company said.