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Guardant Health has agreed to pay $900,000 to settle allegations that it participated in a scheme with a physician to submit charges to Medicare in violation of the False Claims Act. Read More
The FDA has issued a final guidance with recommendations on clinical pharmacology considerations for conducting human radiolabeled mass balance studies, including deciding whether and when to conduct the study, designing the study, and reporting results. Read More
The FDA has sent an additional warning letter to China-based Jiangsu Shenli Medical Production for quality system violations for its enteral syringe products and expanded the company’s import alert to prevent their enteral syringes from entering the US. Read More
In this edition, we note the release of the EU’s highly anticipated AI Act, new reporting requirements for expected interruptions in the supply of medical devices or diagnostics and new guidance on IVD classifications. Read More
Baxter International has issued an urgent medical device recall for certain lots of the Volara system single-patient use circuit and blue ventilator adapter assembly as there is a risk of the device becoming disconnected, resulting in loss of ventilation. Read More
The FDA has issued final guidance on application fees for combination products, explaining that when a sponsor submits a single application for a combination product, the fee should be for that application. Read More
New organizational changes in CDRH to strengthen and better position the Center to meet its mission to protect and promote the public health have been announced by the FDA. Read More
Baxter is recalling the Life2000 Ventilator System due to the potential for failure of the battery charging dongle, which can prevent the system from charging or only allow for intermittent charging — removing them from where they are used or sold. Read More
The FDA should “suspend” its implementation of the laboratory developed test (LDT) rule, the House Appropriations Committee said in its report on its deliberations on the FDA budget for 2025. Read More
AdvaMed commended CMS for its July 10 proposed rule that includes separate payments for diagnostic radiopharmaceuticals are used to diagnose and treat diseases such as Alzheimer’s and cancer. Read More
Hamilton Medical has issued a recall for correction of the software in one of its ventilators, an issue that could cause the device to fail during procedures, a recall which the FDA has deemed Class I, the most serious type as use may cause serious injury or death. Read More
The FDA offers new recommendations for testing and information to include in 510(k) submissions for dental resin devices and the ultraviolet curing lights used to set the resins, in two new draft guidances released Friday. Read More