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Reimbursement / Regulatory

Trice Medical Adds Regulatory Approvals for mi-eye 2 -

Trice Medical received CE Mark Approval and Health Canada approval for the mi-eye 2™ direct visualization tool, and announced completion of first cases in the regions. mi-eye 2 received FDA 510(k) clearance in late 2016 and launched in the U.S. in 2017, where it's now used in >200 settings. The technology is a handheld, single-use tool comprising a wide-angle camera lens embedded in a disposable needle. Physicians can complete a diagnosis on the spot in a clinic, under local anesthetic. (Trice Medical, 3/16/18)