HHS commits more funds for testing, materials to fight pandemic
The U.S. Department of Health and Human Services announced Feb. 17 that it will partner with the Department of Defense to provide a grant of $650 million to expand testing in schools and congregate living settings, including homeless shelters, for the COVID-19 pandemic. The tests will be managed via coordination hubs, and labs will participate in the program to conduct the tests. The program is designed to generate another 25 million tests per month, and will include testing for teachers and students in an effort to bolster in-school learning. The administration has also vowed to invest $815 million to increase domestic production of testing supplies and materials, with an emphasis on antigen point-of-care tests. The CDC will increase its sequencing activities by a factor of three as well.
Medtronic announces recall of Valiant Navion
Medtronic plc, of Dublin, said in a Feb. 17 statement that its recall of unused units of the company’s Valiant Navion thoracic graft stent system was prompted by reports that three patients in a global clinical trial were observed to experience stent fracture. Two of these incidents triggered type IIIb endoleaks, and one patient death was reported. Imaging studies indicated that seven of 87 enrollees in the Valiant Evo global clinical trial exhibited stent ring enlargement beyond the device’s design specification, and Medtronic is following up with a comprehensive root cause investigation. The company said it has contacted the FDA and other regulatory agencies to advise them of the development. Physicians are advised to immediately cease use of the device, which is indicated for repair of the descending thoracic aorta.
Florida man pleads guilty in DME fraud
The U.S. Attorney’s Office for the Southern District of Georgia said Patrick Wolfe, 48, of Belleair Beach, Fla., was sentenced to a 24-month prison term after pleading guilty to a single count of conspiracy in connection with the payment of kickbacks to physicians and nurse practitioners for durable medical equipment and other products. Wolfe will pay roughly $550,000 in restitution as well, and will be required to serve a three-year term of supervised release after leaving prison. Wolfe is said to have flaunted his gains by purchasing a Maserati, and David Estes, acting U.S. attorney for the district, said “a stint behind bars will put the brakes on this conspiracy.” The financial total of orders incurred in this scheme is estimated at multiple millions of dollars.