We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Intuitive Surgical Gets FDA Nod for Ion Endoluminal System
Read MoreHide Full Article
Intuitive Surgical, Inc. (ISRG - Free Report) 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 - Free Report) and Medtronic (MDT - Free Report) 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 - Free Report) — 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.
Zacks' Top 10 Stocks for 2019
In addition to the stocks discussed above, would you like to know about our 10 finest buy-and-holds for the year?
Who wouldn't? Our annual Top 10s have beaten the market with amazing regularity. In 2018, while the market dropped -5.2%, the portfolio scored well into double-digits overall with individual stocks rising as high as +61.5%. And from 2012-2017, while the market boomed +126.3, Zacks' Top 10s reached an even more sensational +181.9%.
Image: Bigstock
Intuitive Surgical Gets FDA Nod for Ion Endoluminal System
Intuitive Surgical, Inc. (ISRG - Free Report) 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 - Free Report) and Medtronic (MDT - Free Report) 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 - Free Report) — 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.
Zacks' Top 10 Stocks for 2019
In addition to the stocks discussed above, would you like to know about our 10 finest buy-and-holds for the year?
Who wouldn't? Our annual Top 10s have beaten the market with amazing regularity. In 2018, while the market dropped -5.2%, the portfolio scored well into double-digits overall with individual stocks rising as high as +61.5%. And from 2012-2017, while the market boomed +126.3, Zacks' Top 10s reached an even more sensational +181.9%.
See Latest Stocks Today >>