Number of the day - da Vinci 5

"Guthart said Intuitive has completed a comprehensive multicenter IDE trial for the da Vinci 5. The trial finished accruing patients in May 2023, with Intuitive submitting for 510(k) clearance in August 2023. The company is responding to the FDA's questions, which Guthart described as falling within normal expectations."

"The da Vinci 5 will join Intuitive’s existing da Vinci robotic surgical system portfolio alongside the multiport X and Xi systems and the single-port SP. There is also Ion, Intuitive’s robotic-assisted platform for minimally invasive biopsy in the lung.

“We are submitted and in the back-and-forth with the FDA. It is our hope for a 2024 launch, but they are ultimately the arbiters of when we get clearance,” CEO Gary Guthart said during an evening earnings call with analysts.

In addition, Intuitive has initiated conversations about da Vinci 5 with regulators in Japan and South Korea, according to Guthart.

"The system has been designed to provide 10,000 times the processing power of its predecessor, for gathering data, improving sensing, and delivering better digital and analytic performance."

Intuitive Surgical CFO Jamie Samath outlined how Intuitive is gearing up for da Vinci 5 manufacturing. The company has already transferred X system production to its East Coast hub near Atlanta. This year, Xi system production will move to Atlanta, too.

Over the next 18 months, the company will open new manufacturing facilities in California for the da Vinci 5 and Ion, he said. It will also complete line transfers for Ion and SP to Mexicali, Mexico."

Source: MassDevice

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