Researchers urge FDA to revoke blood vessel approval

A group of Northeastern University researchers has petitioned the FDA to revoke approval of a new artificial blood vessel, citing safety concerns and deficient clinical trial data. The device, a "biologic" created by Humacyte Global, was approved in December despite internal FDA scientists questioning its safety. The researchers' petition highlights irregularities in trial data and adverse reactions in patients. The researchers are also requesting a public review of the device's safety data and a recall, due to the potential risks associated with the device. The FDA approved the device for use in traumatic injuries.