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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In a draft guidance released yesterday, the FDA recommended improvements in patient labeling information on laser-assisted in situ keratomileusis (LASIK) devices so patients can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
Medical device trade group AdvaMed and dozens of diagnostics and device firms are urging Congress to include diagnostics reform provisions in the FDA user fee reauthorization package that is currently awaiting a Senate vote. Read More
More than 85 percent of previously certified devices in the EU are not yet certified under the Medical Device Regulation (MDR) and the certification process is taking twice as long as it used to, according to a new MedTech Europe survey. Read More
Biotronik has agreed to pay almost $13 million to settle allegations that it paid kickbacks to physicians to encourage their use of the company’s implantable cardiac devices. Read More
The FDA announced Friday that remote regulatory assessments (RRA) have proven to be a valuable tool and the agency will continue to use them beyond the COVID-19 pandemic. Read More
In a final guidance released on Friday, the FDA said it will enforce standard date formatting and Unique Device Identification (UDI) labeling requirements for certain class I and unclassified devices starting on Dec. 8. Read More
The Department of Justice (DOJ) has launched a nationwide law enforcement action against fraudulent billing for cardiovascular and cancer genetic tests and medical devices. Read More
The FDA has granted Breakthrough Device designation to Roche’s Elecsys Amyloid Plasma Panel, a minimally invasive test for early diagnosis of Alzheimer’s through blood biomarkers, which could become the first FDA-approved test for this disease. Read More