The US Food and Drug Administration has granted 510(k) clearance to Zeto, Inc. for its brain monitoring device, the ONE.
The Santa Clara, CA-based medical technology firm said the ONE meets a “significantly unmet” need in health care due to...
Zeto Wins FDA Clearance For Novel Seizure Detection Device
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The US FDA has granted 510(k) clearance to a California medical technology company for a brain monitoring device that detects seizures in patients with brain injury or trauma.
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This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.
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