- In March 2025, CMR Surgical, a U.K.-based global surgical robotics innovator, received FDA clearance for its Versius Surgical System, designed for minimal-access gallbladder procedures. This milestone marks CMR’s official entry into the U.S. market, reinforcing its position as a major player in robotic-assisted surgery. By leveraging compact design and modular usability, CMR Surgical is addressing the growing demand for scalable and efficient surgical solutions in the global medical devices market
- In March 2025, Zydus Lifesciences, a leading pharmaceutical and healthcare company based in India, announced the acquisition of an 85.6% stake in France-based Amplitude Surgical for €256.8 million. This strategic move expands Zydus’s footprint into the global orthopedic surgical devices segment, demonstrating its commitment to innovation and international market expansion in the medical devices industry
- In April 2025, the UK Medicines and Healthcare products Regulatory Agency (MHRA) launched its second AI regulatory sandbox pilot, inviting companies with AI-powered medical technologies—especially those in respiratory care and cancer diagnostics—to participate. This initiative emphasizes the growing significance of artificial intelligence in advancing medical device capabilities and ensuring regulatory readiness for next-generation healthcare solutions
- In June 2025, the European Union introduced new restrictions on Chinese medical device manufacturers, limiting their access to public procurement contracts exceeding €5 million unless they meet specific local production criteria. This policy shift is aimed at ensuring reciprocal access and enhancing the competitiveness of European manufacturers, with implications for global market dynamics and supply chains in the medical devices sector
- In February 2025, Bruker Corporation, a key player in life science instrumentation, unveiled plans for the commercial launch of the CosMx Human Whole Transcriptome Panel, integrating spatial multiomics with high-resolution tissue imaging. This development underlines the company's focus on precision diagnostics and personalized medicine, boosting its standing in the global medical devices landscape
