Yahoo Finance Intuitive Surgical (ISRG) Seeks FDA Nod for Next-Gen da Vinci 5
Intuitive Surgical ISRG announced that it has submitted an application for FDA 510(k) clearance of its next-generation da Vinci 5 multiport surgical robot.
The company’s da Vinci robotic surgical system family will include the new da Vinci 5, as well as the X and Xi systems with multiple ports and the SP system with one port. It also has Ion, a robotic-assisted device for lung biopsy with minimal invasion. The addition of the next-generation da Vinci 5 will be a significant addition to its portfolio.
The company expects an approval soon, which will be followed by a launch later this year.
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On its fourth-quarter earnings call, Intuitive Surgical announced that it has successfully completed a thorough IDE trial for the da Vinci 5 in multiple centers, according to Guthart. The trial enrolled patients until May 2023, and ISRG applied for 510(k) approval in August 2023. The company is currently answering FDA’s queries. In addition, Intuitive Surgical is also discussing the approval pathway for da Vinci 5 with regulators in Japan and South Korea.
Investors have been eagerly waiting for ISRG’s new da Vinci system. The company's shares lost a year ago as there was no announcement of any new multiport system in 2023.
Intuitive Surgical is preparing to manufacture da Vinci 5. The company has moved X system production to its Atlanta hub. Xi system production will also go to Atlanta this year. The company said it will open new plants in California for da Vinci 5 and Ion in the next 18 months. It will also finish moving Ion and SP lines to Mexicali, Mexico.
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Another company from the same industry, Masimo MASI, won a favorable court ruling in its intellectual property dispute with tech-titan, Apple AAPL over blood oxygen sensors in newer Apple Watch models.
Per the latest ruling in the ongoing patent dispute litigation, Apple has to stop selling watches with the oxygen measurement feature while an appeal of the ban plays out. Masimo sued Apple in 2020 when the latter added a blood oxygen sensor to its watches, starting with Series 6. Following a three-year-long battle, Masimo received its first favorable ruling against Apple.
DexCom DXCM, another company in the same industry, unveiled its new state-of-the-art manufacturing facility in Athenry. With the ability to produce millions of Dexcom rtCGM sensors annually, the new plant will contribute to the betterment of diabetes patients throughout Europe, the Middle East and Africa (EMEA). Dexcom's first manufacturing plant in Europe will guarantee product flow throughout EMEA, potentially reducing goods costs and improving sustainability by cutting down on transit delivery times.
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