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

In-Vivo Dosimetry System Ensures Delivered Dose Accuracy in Cancer Radiation Therapy

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. For more information visit: http://scandidos.com/home/solutions/at-treatment-qa/deltasup4sup-discover.

About ScandiDos AB

ScandiDos AB is a worldwide leader in the development of advanced dosimetry and QA (Quality Assurance) products that ensure radiation doses in advanced cancer radiation therapies are delivered to the patient in the quantity and manner intended. The company’s measurement systems and software are designed to meet QA requirements and provide validation for new cancer radiation treatments being implemented in clinics around the world.

ScandiDos was founded in 2002 and is headquartered in Uppsala, Sweden. The company operates worldwide, with a U.S. office in Madison, Wi. and international offices in Beijing and Paris. ScandiDos has installed its dosimetry and QA solutions in 40 countries and its systems can be found in well-known cancer centers throughout the United States. Since April 2014, ScandiDos has been listed on NASDAQ First North Stockholm with the ticker symbol SDOS.

Contacts

For ScandiDos
Didit Communications
Liz Burke, Office: +1-516-629-3285
Mobile: +1-917-573-1440
liz.burke@didit.com
or
ScandiDos
Görgen Nilsson, Madison, Wi. office: +1-608-630-9415
Uppsala, Sweden office: +46 18 472 30 30
President & CEO
gorgen.nilsson@scandidos.com

Release Summary

ScandiDos received US FDA clearance for Delta4 Discover, bringing to market the first device that independently verifies the radiation dose delivered to a patient during radiation treatment.

Contacts

For ScandiDos
Didit Communications
Liz Burke, Office: +1-516-629-3285
Mobile: +1-917-573-1440
liz.burke@didit.com
or
ScandiDos
Görgen Nilsson, Madison, Wi. office: +1-608-630-9415
Uppsala, Sweden office: +46 18 472 30 30
President & CEO
gorgen.nilsson@scandidos.com