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Irvine, Calif.-based enVVeno Medical has released promising data from a first-in-human study of its VenoValve implant for the treatment of chronic venous insufficiency (CVI). Read More
If a device sponsor wishes to appeal a rejection from the FDA’s Center for Devices and Radiological Health (CDRH), it should follow the chain of command to the next level up from the official who made the decision, the agency said in a final guidance released yesterday. Read More
Minnesota device developer Cardiovascular Systems (CSI) has unveiled plans to expand its reach in thrombectomy devices by partnering with California-based Innova Vascular. Read More
The image analysis provides patient-specific measurements, such as muscle, fat and liver fat volumes, with a comparison to others of the same sex and body type. Read More
In a clinical trial of the Teleflex devices, technical success, defined as successful guidewire recanalization, was achieved in 93.3 percent of cases. Read More
The tip damage could lead to vascular injuries, including blockage of the vessel, additional blood clots, inadequate blood supply, heart attack, infection or death, the agency said. Read More
The FDA has issued a Form 483 to medical device and biologics manufacturer Lonza based on an inspection last November of the company’s facility in Walkersville, Md. Read More
The Friends of Cancer Research (FOCR) is urging the FDA to better coordinate simultaneous approval of new cancer drugs and companion diagnostics, and to focus on more speedy approval of diagnostics for rare cancer biomarkers. Read More
Viatris, formerly Mylan, has agreed to a $264 million settlement to resolve a class-action lawsuit alleging that the company, along with Pfizer, had taken part in a scheme to delay generic competition to its EpiPen allergy treatment, used to quickly administer epinephrine to treat potentially fatal allergic reactions. Read More