Medtronic plc’s Hugo robotic-assisted surgery system has received a CE mark for urologic and gynecologic procedures, paving the way for commercialization in Europe. The approval is a key milestone for the Dublin-headquartered company, following the launch of Hugo in Latin America and India. The company is prioritizing robotics as a major growth opportunity, but will face tough competition in the space as it goes head-to-head with established market leader Intuitive Surgical Inc. According to Medtronic, Europe could provide a significant opportunity due to its current low uptake of surgical robotic procedures.

Robotic technologies company Stereotaxis Inc. is scaling up its footprint in the Chinese med-tech market, with a deal to commercialize its robotic technology for heart rhythm therapy in China with Shanghai Microport EP Medtech Co. Ltd. The St. Louis-based Stereotaxis aims to introduce a second-generation robot called Genesis to the Chinese market that uses a magnetic navigation technology to treat heart rhythm disorders. Its partner, Shanghai Microport EP Medtech, is a division of one of China's largest med-tech manufacturers, Shanghai-based Microport Scientific Corp.

The FDA has posted an advisory regarding robotically assisted surgery (RAS) for mastectomy, but the agency also pointedly noted that it is aware of studies underway for such indications without the appropriate oversight. The FDA did not name Intuitive Surgical Inc. in the notice, but the company nonetheless responded to the FDA statement by confirming the absence of any devices thus approved or cleared. The FDA had previously issued a Feb. 28, 2019, advisory stating that the safety and efficacy of RAS devices for mastectomy and the prevention or treatment of breast cancer had not been established.

Memic Innovative Surgery Ltd. agreed to combine with Medtech Acquisition Corp. in a transaction expected to close in the fourth quarter of 2021. The deal establishes an eye-popping $1 billion pro forma valuation for the company, which received FDA clearance for its first device just four months ago.

Rsip Vision Ltd. has maintained its momentum with a couple of new software module releases, one focused on sports medicine and another for robotic assisted surgery. The most recent release is a software module that enables deep learning-based segmentation of joint cartilage from MRI scans of hips, knees and ankles. “It's about using AI-based auto segmentation to provide clinically valuable measurements,” Moshe Safran, the CEO of Rsip Vision U.S., told BioWorld.

LONDON – CMR Surgical Ltd. has once again broken the record for a private financing round by a European med-tech company, raising $600 million in a series D funding round. That follows on from two other record-breaking rounds, in which the Cambridge, U.K.-based CMR raised $240 million in a series C in September 2019 and $100 million in the series B round that closed in May 2018. These earlier rounds enabled CMR to complete development and install the first commercial versions of its Versius surgical robots. Now the series D will push the company through to profitability, the company said.

TORONTO – Titan Medical Inc. has received a $10 million license payment from Medtronic plc for a total of $30 million that the Irish med-tech firm has invested in robotic-assisted surgical technologies developed by Titan. Titan is pursuing gynecologic surgical applications for its Enos robotic single access surgical system, licensing it and related intellectual property to Medtronic while retaining worldwide rights to commercialize technologies for use with the Enos system.

PARIS – Microsure BV reported closing a $3.25 million funding round to develop its supermicrosurgery robot, Musa. This series B round was led by Dutch investment agency Invest-NL NV. The other 50% of the funding came from existing Dutch shareholders Brabant Development Agency NV and venture capital partners Innovation Industries Fund, as well as from Ten Cate Investreingsmaatschappij BV.

Zimmer Biomet Holdings Inc. has won the FDA’s nod for its Rosa Partial Knee system for robotically assisted partial knee arthroscopy. The new system is the latest addition to the Rosa Robotics platform, which also includes the Rosa Knee system for total knee replacement and Rosa One for neurosurgical and spine procedures. The Rosa Partial Knee system is designed to be compatible with Zimmer’s Personal partial knee. It incorporates 2D to 3D X-Atlas imaging technology and real-time, intraoperative data collection on both soft tissue and bone anatomies to ensure accurate bone cuts and improve range of motion gap analysis.

Memic Innovative Surgery Ltd. secured a major cash infusion to bring its freshly FDA-authorized Hominis robotic-assisted surgical platform to market. Peregrine Ventures and Ceros led the $96 million series D financing round with participation from Ourcrowd and Accelmed.