The U.S. FDA recently cleared Medtronic plc’s Hugo robotic-assisted surgery system and CMR Surgical Ltd.’s Versius Plus system, adding new options to the U.S. market to meet rising demand for robotic procedures. While Intuitive Surgical Inc. currently dominates the soft tissue surgical robotics space, these new entrants will provide hospitals and health care systems with greater choices when it comes to purchasing systems and expanding systems. Read More
The U.S. FDA’s final guidance for clinical trial inspections conducted under the bioresearch monitoring (BiMo) program seems to deviate little if at all from the 2024 draft, but that is precisely the rub for some stakeholders. The Advanced Medical Technology Association pressed the agency to ensure that the final guidance takes into account the hazards of electronic access during remote BiMo audits, but the final guidance makes no such concessions. Read More
IPOs top the list of the big stories in 2025 in med tech. Thirty med-tech companies went public, raising nearly $12 billion, two orders of magnitude more than in 2023 and almost 20 times more than raised in 2024. Read More
Advanced Biomed Inc. reported Dec. 30 the sale of its wholly owned Hong Kong subsidiary, Advanced Biomed (HK) Ltd., and related intellectual property to buyer Wei Ha Hui for $23,000. Read More
Surgical robotics maker Shenzhen Edge Medical Co. Ltd. reported its initial public offering on the Hong Kong Stock Exchange to raise HKD$1.19 billion (US$154 million) to advance its pipeline of surgical robotic systems and expand its geographic footprint to markets outside China. Read More
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Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: HAI Solutions. Read More
-12-31.webp?t=1767210422 "Advanced Biomed’s A+Perfusc 3D cell culture system")
