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News We're Watching: Breakthrough Retinal Scan For CV Disease, InfoBionic's AI-Powered Remote Monitoring, And More

 
• By Reed Miller and Marion Webb

Some of the industry news from last week that Medtech Insight is tracking: The FDA granted its breakthrough status to Toku's Clair AI technology for finding markers of cardiovascular disease in retinal scans. Dupont is partnering with STMicroelectronics on a new patch sensor technology, ReWalk secures Medicare coverage for its exoskeleton, and more.

Industry News We're Watching
• Source: Shutterstock

ReWalk Robotics announcedyet another milestone in its efforts to solidify Medicare coverage and help more people with spinal cord injuries gain access to its exoskeleton technology.

After announcing that the Centers for Medicare and Medicaid Services ruled that exoskeletons would be covered in the Medicare brace...

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After Thought-Control Demo, Synchron Plans Pilot Study With Upgraded BCI On Path To Pivotal Trial

 
• By Marion Webb

Synchron is preparing a pilot study of its fully wireless, second-gen brain-computer interface after an ALS patient controlled an iPad solely by thought. If all goes as planned, Synchron’s BCI will move into pivotal trials in 2026.

Exact Sciences Reveals Thinking On CRC Liquid Biopsy After Freenome Deal

 
• By Natasha Barrow

Exact Sciences has entered into an exclusive licensing agreement with Freenome, stipulating clinical benchmarks and a first-line rating in the USPSTF guidelines. Medtech Insight interviewed screening CMO Paul Limburg about CRC screening and Exact’s strategy on liquid biopsy.

Fresh Off $100M IPO, Carlsmed Plans For Growth, 2026 Launch Of Customized Cervical Fusion Implant

 
• By Marion Webb

Fresh off an IPO, spinal implant maker Carlsmed is preparing to launch a new cervical fusion application for its aprevo tech. Medtech Insight has two perspectives on these recent moves: CEO Mike Cordonnier and the doctor who performed the first spinal fusion using the technology.

HistoSonics Sells Majority Stake To Investor Syndicate In Deal Valued At $2.25Bn

 
• By Marion Webb

HistoSonics’ CEO Michael Blue describes the deal as a win-win for all stakeholders and plans to use the money to expand clinical indications, as well as the global reach, for its Edison system.

More from Digital Technologies

PathAI Talks PCCPs: ‘Accelerated Software Updates, Saves Time And Money’

 
• By Natasha Barrow

The US FDA has authorized around 107 devices with Predetermined Change Control Plans in place, with PathAI's AISight Dx digital pathology image management system one of the latest. Medtech Insight talks to Eric Walk, chief medical officer, to find out about the process and its benefits.

SpotitEarly Sets Up US HQ, Launches Trials For Dog- And AI-Powered Early Cancer Detection Test

 
• By Marion Webb

Among early cancer screening tests, SpotitEarly stands out by combining dogs’ superior sense of smell with machine learning. SpotitEarly plans two US clinical trials for breast and lung cancer aiming to seek FDA clearance, but needs more funding to support clinical development and commercialization.

Ultromics Wins $55M, The Key To Success: Diagnosing Diseases With Available Treatment

 
• By Natasha Barrow

Ultromics has secured $55m in Series C funding to advance its AI tool, EchoGo, which detects undiagnosed heart failure. The company's focus on diseases with available treatments resonated with investors.