Truvian is looking for partners to continue advancing its benchtop blood testing platform, which could be headed for corporate clinics, retail pharmacies, and physician networks in 2025, pending US FDA clearance next year.
Truvian’s website articulates the promise of its desktop blood-testing analyzer thus: “A few drops of blood. No send outs. Fully automated. Accurate results in minutes.”
It has echoes of the sorts of claims that brought down Bay Area startup Theranos Inc., a tale that...
Just a year and four months after publishing a final rule that would have allowed it to regulate laboratory developed tests as medical devices, the US FDA has rescinded the controversial measure, finally putting an end to the saga.
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.
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.
Despite headwinds, executives remain optimistic about growth in Abbott’s medical devices and diabetes divisions and plan several product rollouts, including the Volt PFA catheter for electrophysiology and the dual glucose-ketone sensor CGM.
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.
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.
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.
