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THE TAPE

Axogen to pay $200M cash for BioCircuit and its sutureless NerveTape FDA codifies eight De Novo device types as Class II, three years after granting them Precera Medical buys Additive Metal Services to bring metal injection molding in house Powerful Medical wins a De Novo for AI that flags heart attacks on a 10-second ECG Zenflow says four US centers have run the first commercial Spring cases FDA says it has never authorized a clear aligner sold without a prescription CraniUS clears a patient-specific cranial plate under K261058 FDA clears Emboline's Emboliner, a TAVR filter tested head to head against Sentinel Petal Surgical shows its histotripsy robot and says first-in-human is close Axogen to pay $200M cash for BioCircuit and its sutureless NerveTape FDA codifies eight De Novo device types as Class II, three years after granting them Precera Medical buys Additive Metal Services to bring metal injection molding in house Powerful Medical wins a De Novo for AI that flags heart attacks on a 10-second ECG Zenflow says four US centers have run the first commercial Spring cases FDA says it has never authorized a clear aligner sold without a prescription CraniUS clears a patient-specific cranial plate under K261058 FDA clears Emboline's Emboliner, a TAVR filter tested head to head against Sentinel Petal Surgical shows its histotripsy robot and says first-in-human is close

The Directory / Digital Health & SaMD

Viz.ai

San Francisco, CA · Series D+ · De Novo granted

Builds AI software that detects suspected disease on medical images and physiological data and routes the case to a specialist. Its Viz HCM device led FDA to create a new Class II regulation for cardiovascular machine learning notification software.

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Viz.ai

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