Candelis Announces FDA 510 (K) Clearance for ASTRATM Cloud-Hosted Suite of Services

NEWPORT BEACH, Calif.--(BUSINESS WIRE)-- Candelis, Inc. today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its ASTRA™ cloud-hosted suite of software services which include ASTRA PlusTM, ASTRA LiteTM and ASTRA MobileTM.

ASTRA Plus is a downloadable software application which enables users to securely send and receive imaging studies and reports across a WAN, and to route studies across a LAN via DICOM. Studies and reports can be viewed, displayed, printed and archived using tools provided within the application. By facilitating the sharing and distribution of medical imaging studies and reports, ASTRA Plus enhances patient care and outcomes and eliminates the need for potentially harmful and costly duplicate imaging procedures.

ASTRA Lite is a true thin client, browser-agnostic tool providing referring physicians with a unified portal for the viewing of medical imaging reports and embedded key images. The physician can optionally download and save a full-fidelity PDF of the report. ASTRA Lite provides a highly secure means of delivery of radiologist reports and findings to referring physicians, surgeons and clinicians, thereby improving patient care.

ASTRA Mobile, developed specifically for Apple’s iPad, iPhone and iPod Touch, enables users to receive, view, download, and print medical reports and key images anywhere in the world. “We intend to continue to expand our portfolio of cloud-integrated toolsets in those areas where we can create value for hospitals, imaging centers, clinics and the physicians who diligently serve the patient population,” said Steven Higgins, Candelis CTO.

About Candelis, Inc.

A medical informatics company based in Irvine, California, Candelis™ develops innovative, cost-effective solutions for the healthcare IT industry specifically focused on image visualization, workflow, archival and reporting. Candelis provides these solutions in the areas of Mammography, Radiation Therapy/Oncology and General Radiology to hospitals, imaging centers and clinics.

Candelis’ technical leadership has been validated through a number of successful OEM partnerships with top-tier healthcare vendors. The company's latest product offering, ASTRA, has quickly become recognized as a transformational solution. ASTRA leverages the evolution of cloud-based computing and storage to enable the secure, rapid and reliable transfer and sharing of studies, images and reports amongst healthcare facilities.


Candelis, Inc.
Hossein Pourmand
Vice-President, Business Development
e-mail: [email protected]
Tel: (949)798-8109

KEYWORDS:   United States  North America  California

INDUSTRY KEYWORDS:   Technology  Networks  Software  Telecommunications  Practice Management  Health  Radiology  FDA  Managed Care



White Paper

How to Grow Membership with Comprehensive Sales Technologies

To win, healthcare payers need a breakthrough shopping experience alongside a comprehensive view of the sales pipeline. In this industry white paper, payers can learn how to accelerate acquisitions and engage shoppers with truly integrated, comprehensive sales technologies.