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01.11.2023 - LimFlow SA, a pioneer in the development of minimally-invasive technology for the treatment of chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease (PAD), announced today that it has entered into a definitive ...
Press Release Toku, Inc., a commercial medical device company specializing in imaging technology and AI, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation to its patented CLAiR technology. The CLAiR platform, if…
Toku’s platform aims to deliver real-time cardiovascular disease (CVD) risk assessments using routine eye exams.
Data from first coronary DCB study in U.S. meet 12-month primary endpoint, demonstrate low adverse event rates with AGENT DCB
On September 15, 2023, FDA released a final guidance document titled "Breakthrough Devices Program." Compared to the previous version, the new guidance document highlights that the Breakthrough Devices Program ...