CMR Surgical Ltd. hopes to soon gain U.S. FDA 510(k) clearance for its Versius Plus surgical robotic system to bring it to the U.S. market amid rising demand for robotic surgery. Although the company’s original Versius system received FDA clearance in 2024 for use in cholecystectomy in adults, CMR waited to bring the enhanced Versius Plus model to market instead. “I have such a respect for the U.S. market that the last thing that I would do is to enter a market with a product that is outdated,” Massimiliano Colella, CMR CEO told BioWorld.
Momentis Surgical Ltd. received 510 (k) clearance from the U.S. FDA for the second-generation of the Anovo robotic surgical platform. The upgraded system allows surgeons to experience enhanced ergonomics with integrated haptic feedback, creating more intuitive control of the robotic arms during surgical procedures.
The U.S. FDA granted Momentis Surgical Ltd. 510(k) clearance for its Anovo robotic surgical platform for use in single site, abdominal access ventral hernia repairs. The U.S. regulatory agency also gave the greenlight to CMR Surgical Ltd.’s Versius system for use in cholecystectomy, in a sign of the growing market for smaller, more portable robotic devices to assist in minimally invasive procedures.
The U.S. FDA granted Virtual Incision Corp. de novo marketing authorization for its miniaturized in vivo robotic assistant for use in colectomy procedures in adults. The two-pound device offers portability and quick setup, eliminating the need for specialized operating rooms or arrangements to accommodate robotics.
There’s nothing scary for Ametek Inc. shareholders in the $1.9 billion acquisition of Paragon Medical Inc. announced on Oct. 31, 2023. The deal moves the industrial technology company solidly into the med-tech space as it picks up Paragon’s portfolio of products in orthopedics, minimally invasive surgery, robotic surgery and drug delivery, and adds an estimated $500 million per year in revenue and “very strong EPS accretion,” Ametek CEO David Zapico said in an investor call on Oct. 31.
Medical Microinstruments Inc. (MMI) is expanding its Symani surgical system into the Asia Pacific – a region with “clear demand for the technology” – through two local partners, Device Technologies Australia Pty Ltd. and Seoul-based TRM Korea Corp.
Microsure BV recently secured €38 million (US$40 million) in a series B2 funding round that will allow it to finalize the development of its microsurgical robot, the Musa-3. The robot system is designed to give microsurgeons the precision, stability and control that are currently beyond human capabilities. “We want to make a super microsurgeon from every microsurgeon,” Sjaak Deckers, CEO of Microsure, told BioWorld.
The venture capital market in South Korea is frozen shut, said presenters during the recent BIO Korea 2023 conference in Seoul, but Korea’s Medical Device Development Fund will help support domestic R&D efforts to the tune of ₩987 billion (US$738 million) over five years.
Quantum Surgical SAS has obtained an extension to the FDA authorization covering its Epione robot, which can now treat abdominal cancers. “This decision now allows physicians to treat all abdominal tumors at an early stage and will ramp implementation of our Epione robotics solution in the U.S.,” said Bertin Nahum, CEO and co-founder of Quantum Surgical. Marketed in Europe and the U.S., the Epione robot has already been used to treat more than 150 patients with liver or kidney cancer.
