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ViaCyte’s implantable pouch filled with stem-cell-derived pancreatic cells is advancing in a first-in-human type 1 diabetes trial, showing clinically meaningful improvements in glycemic control and blood sugar, accompanied by a 70 percent decrease from the peak insulin dose. Read More
The FDA usually follows the advice of its advisory committees, but what that will mean in the case of Integra LifeSciences' SurgiMend for breast reconstruction is anybody’s guess, because the agency’s General and Plastic Surgery Devices Panel was deeply divided on the device’s safety and efficacy when it met last week. Read More
Vertex Pharmaceuticals will submit an Investigational New Device (IND) application next year for a drug/device combination that delivers insulin-producing, lab-created islet cells in a membrane packet to protect them from the body’s immune system. Read More
The FDA reminded in vitro diagnostic (IVD) makers that they must get Institutional Review Board (IRB) approval for clinical studies of IVDs that involve human subjects, including those using leftover, deidentified human specimens in FDA-regulated studies. Read More
The clinical trial will evaluate 263 patients who are being treated at two vertebral levels either with the M6-C disc or with discectomy and fusion. Read More
The randomized multicenter study will gauge the device’s ability to safely reduce intra- or postoperative cerebrospinal fluid leakage in patients undergoing cranial surgery. Read More
The FlowTriever system has received both FDA 510(k) clearance and CE mark certification for treating pulmonary embolisms and clots in the heart’s right atrium. Read More
The FDA’s Center for Drug Evaluation and Research (CDER) issued a warning letter to Foshan Biours Biosciences, a combination drug/device manufacturing facility in Guangdong, China, following a records-based inspection that revealed inadequate testing and cleaning validation for the company’s biomedical patch. Read More