Accuray (ARAY) Receives 510(k) FDA Clearance for Radixact

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Accuray Inc ARAY recently received the much-awaited 510(k) clearance for its Radixact Treatment delivery platform, Precision Treatment Planning System and iDMS Data Management System, from the US FDA.

The hardware (Radixact) and software solutions combine to form the Radixact system, which is an evolved form of Accuray’s TomoTherapy System in terms of treatment speed and ease of use. The company plans to commercially launch the system late in first-quarter fiscal 2017 (July to September 2016).

The new platform unifies delivery, planning and data management of the treatment into a single solution. The Radixact system features a powerful linear accelerator, MVCT imaging and helical treatment delivery, which enable the treatment of target tissues without harming healthy tissues in the surrounding areas.

The next-generation Precision Treatment Planning System allows clinicians to change delivery options according to tumor size, shape and location within the patient during treatment.

ACCURAY INC Revenue (TTM)

ACCURAY INC Revenue (TTM) | ACCURAY INC Quote

The FDA approval is a major step in the evolution of Accuray’s TomoTherapy platform, which is the only radiation system designed for image-guided intensity-modulated radiation therapy (IG-IMRT).

The next-generation Radixact system will boost Accuray’s penetration in the radio-therapy market, which is estimated to reach $7.54 billion by 2020, as per data available from Markets & Markets.

Moreover, continued penetration and market share gains by the TomoTherapy system in single and dual vault accounts will drive gross order growth in fiscal 2017.

Zacks Rank & Key Picks

Accuray carries a Zacks Rank #3(Hold).

Some better-ranked stocks in the medical space are Cryolife Inc CRY, IRadimed Corp IRMD and Masimo Corp MASI. All the three stocks sport a Zacks Rank #1 (Strong Buy).

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