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Intuitive Surgical Gets FDA Nod for Ion Endoluminal System

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Intuitive Surgical, Inc. ISRG announced that the U.S. FDA has granted 501(k) clearance for the Ion endoluminal system to enable minimally invasive biopsy in the peripheral lung. The company plans a limited rollout of the platform in the United States, with customer shipments to commence during the second quarter of 2019.

About Ion

Ion is a new robotic endoluminal platform in development for peripheral lung biopsy. The system features an ultra-thin, ultra-maneuverable catheter that allows navigation far into the peripheral lung. Moreover, its unprecedented stability enables the precision needed for biopsy.

Apart from lung nodule biopsy, Ion integrates existing imaging technology including fluoroscopy, radial-endobronchial ultrasound, and cone-beam CT.

Market Prospects

The Ion platform represents Intuitive Surgical’s solid focus on minimally invasive care. Per Mordor Intelligence, the global minimally invasive devices market is expected to multiply at a CAGR of nearly 8% during the 2018-2023 time frame. Apart from Intuitive Surgical, Abbot Laboratories ABT and Medtronic MDT are the other key players in this space.

The latest development also provides Intuitive Surgical a favorable exposure in the peripheral lung biopsy markets. Per GlobeNewswire, Lung Cancer Diagnostics market size is projected to reach a worth of $3.64 billion by 2024. Notably, the market is consolidated in nature. In 2018, Qiagen N.V. QGEN — a global player in the niche space — received the FDA approval to expand the usage of EGFR test in lung cancer.

A Plethora of Regulatory Approvals

Favorable tidings on the regulatory front have always favored Intuitive Surgical. Of the latest ones, the company submitted 510(k) for the second indication of TransOral Robotic Surgery. It is also working through supply chain optimization as Intuitive Surgical begins to ramp up production for SP.

Further, a suite of regulatory approvals for the Vessel Sealer Extend — the da Vinci SP Surgical System — and the Sure Form 60 buoys optimism.

Intuitive Surgical gained significantly on the CE Mark approval for da Vinci X in Europe. The stock has got a further boost from the recent FDA approval of the same.

Price Performance

Intuitive Surgical outperformed its industry in a year’s time. The Zacks Rank #3 (Hold) company has gained 40%, comparing favorably with the industry’s 9.9% growth. The current level is also higher than the S&P 500's decline of 6.1% over the same time frame. You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.


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