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Johnson & Johnson MedTech’s Monarch platform and Monarch bronchoscope obtained regulatory approval in China. Approval makes Monarch the primary minimally-invasive, robotic-assisted know-how accepted for peripheral lung procedures in China. It’s additionally the primary Johnson & Johnson MedTech robotic-assisted know-how to obtain approval in China. The regulatory nod additionally marks the primary such milestone for Monarch outdoors the U.S.
J&J acquired Monarch when it purchased Auris for $3.4 billion in 2019, coming into the robotic surgical procedure market. It already held FDA clearance for bronchoscopy and final yr picked up clearance for endourological procedures.
The firm designed the system to offer bronchoscopic visualization of and entry to grownup affected person airways. Uses embrace diagnostic and therapeutic procedures. It permits the usage of minimally invasive, robotic-assisted know-how for peripheral lung procedures. This may enhance the flexibility to entry small, hard-to-reach peripheral lung nodules at an earlier stage and with higher precision.
Will Song, president of J&J MedTech China, mentioned the approval leaves Monarch poised to help physicians as they “fight one of the most prevalent and deadly diseases in the country” in lung most cancers.
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“The Monarch team is committed to driving meaningful innovation that changes the way patients experience healthcare,” mentioned Adrian Whitford, president, Monarch. “Expanding the reach of flexible robotic-assisted devices for lung procedures to countries around the world is part of our vision to deliver breakthrough technology that improves clinical outcomes for patients fighting diseases like lung cancer.”
It’s one other constructive step within the surgical robotics area for the corporate, which issued an replace on its Ottava surgical robotic final week. The firm mentioned it plans to submit Ottava for FDA investigational system exemption (IDE) within the second half of 2024 to provoke medical trials.
“Johnson & Johnson was born in surgery with the advent of sterile sutures, and we have since helped surgeons improve care for patients by offering transformative technologies across all types of surgery,” Hani Abouhalka, the corporate group chairman of robotics and digital surgical procedure at Johnson & Johnson MedTech mentioned in a launch. “We believe the future of surgery is personal. Starting with the human impact – the connection between the patient, surgeon, and OR staff – we are unlocking what science and technology can do to improve the surgical experience and health outcomes for everyone involved. Ottava is designed to consistently deliver this experience in any OR globally.”
Editor’s Note: This article was first revealed on sister web site MassDevice.