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With the last of the Top 100 medtech companies filing 2024-25 revenues in November, Medtech Insight now presents its latest ranking of cardiology, orthopedic, diagnostic imaging and in vitro diagnostics companies.
The US FDA’s General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee convened Wednesday to discuss germicidal ultraviolet (GUV) devices as a mode of disinfection, a technology that has emerged since the COVID-19 pandemic.
Neurotech start-up Subsense raised another $10m, bringing its total seed funding to $27m. The proceeds will be used primarily to accelerate and enhance the company’s pre-clinical research program.
The rise and fall of US tariffs and the chill headwind from China’s state procurement policies have blown onto medtech’s radar. But how to monetize AI is the dominant concern up and down the industry.
Freenome will combine with Perceptive Capital Solutions Corp in a SPAC deal worth $330m. The goal is to advance Freenome’s blood-based tests for early detection of cancer and, in 2026, launch its advanced colorectal cancer detection test SimpleScreen, currently under FDA review.
The US FDA is launching a pilot to promote access and safety to digital health devices. Developed by the agency’s device center, the pilot will evaluate a new, risk-based enforcement approach for certain types of digital devices to treat several conditions.
Medtronic won FDA clearance for its Hugo surgical robot for urologic procedures, which Wiliam Blair analyst expects will draw interest from physicians. But he also says that Intuitive Surgical will remain the clear dominant player.
Pending legislation in the US House of Representatives would allow Medicare patients to benefit from some of the latest and most innovative technologies. The bipartisan bill would establish a clear pathway for reimbursement for algorithm-based healthcare services approved by the FDA.
Paradromics won FDA clearance to test its Connexus BCI in two people with severe speech impairment. The 2026 trial will assess whether the device can decode speech in real time.
With the roll out of agentic AI, the US FDA continues to expand AI capabilities across the agency. The latest AI deployment follows the agency’s May launch of Elsa, its generative AI tool, which marked ‘the dawn of the AI era’ at the FDA.
