New Products In Brief
This article was originally published in The Gray Sheet
Bausch & Lomb gets approval for first-of-a-kind intraocular lens. Roche HbA1c assay is first to be cleared to diagnose diabetes. More product launches and approvals from the past week.
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FDA spells out the special controls needed for class II specification of hemoglobin A1c test systems in a final order taking effect Sept. 24.
3D breast tomosynthesis improves the recall rate and cancer-detection rate of mammography, according to a retrospective study of 454,850 examinations. The results may be good news for Hologic, which has struggled to accelerate adoption for the technology due to lack of reimbursement.
Thoratec Warns Of Potentially Lethal Complications When Patients Switch To New HeartMate II Controller
Serious adverse events have been linked to patients struggling to switch their Thoratec HeartMate II left-ventricular assist devices from an older controller system to the newer Pocket Controller system. The company is updating the labeling and training materials for the system and warning doctors and patients to communicate to ensure they understand how to convert to the Pocket Controller.