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Novartis’ Alcon unit is recalling more than 43,000 units of its AcrySof IQ Toric, expanding a previous recall of more than 45,000 intraocular lenses earlier this year in Japan. Read More
Sunlamp manufacturers would be required to take additional measures to improve the overall safety of tanning beds under new rules proposed by the FDA. Read More
The once-hot startup Theranos got more bad news last week — this time in the form of a letter from the Centers for Medicare & Medicaid Services. Read More
Brainlab is recalling its cranial image-guided surgery system due to potential inaccuracies in the display compared with a patient’s anatomy. Read More
Stryker is recalling its Fuhrman pleural and pneumopericardial drainage set because of the potential for the device’s catheter to break during insertion. Read More
The FDA has alerted Puerto Rican healthcare providers and facilities not to use Customed’s convenience packs and trays for surgical procedures. Read More
The FDA has hired a team of tough new investigators to crack down on medical devicemakers whose software doesn’t measure up in terms of verification and validation (V&V). Read More
A lack of documented testing of updated instructions for use for cleaning a heater-cooler system has helped earn LivaNova an FDA warning letter. Read More