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Hospitals and other healthcare institutions must follow certain administrative measures for quality supervision on the use of medical devices, under a new regulation issued by China’s FDA that focuses on procurement, maintenance, supervision and documentation. Read More
Failure to conduct adequate investigations of complaints related to its volumetric infusion pumps and not providing corrective action documents are among the issues that have landed WalkMed Infusion an FDA warning letter. Read More
eVent Medical has implemented a Class 1 recall of its Inspiration ventilators, citing a faulty switch on the power board that may fail, causing the device to shut down without sounding an alarm. Read More
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
The FDA’s Office of Regulatory Affairs is making progress on its new program alignment and released information on what the new structure will look like. 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 FDA is ratcheting up requirements for surgical mesh for transvaginal repair of pelvic organ prolapse, issuing two final orders that address safety risks. Read More
The FDA is hoping to improve the quality and accuracy of genomic tests, through the launch of a new online portal that will allow for collaboration on developing the science behind next-generation sequencing. Read More
bioMerieux is recalling 3,760 units of its Etest PIP/TAZO/CON-4 PTC 256 because its results could indicate that antibiotic therapy using PIP/TAZO could stop or slow the growth of certain bacteria, when it may not be effective in doing so. Read More