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South Korea-based Ilooda’s Secret Duo laser device has been approved by the FDA to help treat scars such as those left by monkeypox infections. Read More
The FDA needs to clarify its draft regulatory framework for 3D printing at the point of care (3DPOC), according to a new analysis from the Pew Charitable Trusts. Read More
The reagent kit is intended for use with the company’s soluble FMS-like tyrosine kinase-1 (sFlt-1) reagent kit for detecting the sFlt-1 protein in maternal serum. Read More
Establishing operational limits is a key issue to consider. These are the limits that are obtained during the operational qualification (OQ) testing over the expected operating range. So for instance, this applies to equipment and cleaning practices over the expected range, the history or the variety of products that you’re running. Read More
Philips is in discussion with the Department of Justice (DOJ) over a consent decree relating to the company’s June 2021 recall of millions of continuous positive airway pressure (CPAP), bi-level positive airway pressure (BiPAP) and ventilator devices. Read More
In a draft guidance released yesterday, the FDA recommended improvements in patient labeling information on laser-assisted in situ keratomileusis (LASIK) devices so patients can better understand the benefits and risks involved. Read More