Elizabeth Orr is managing editor of US regulatory and policy for Medtech Insight, which she joined in 2015 as a reporter focused on legal issues. She remains fascinated by the ever-changing master class on technology, government regulations, advances in health care and more that is covering the device industry. Elizabeth’s past employers include FDANews; DecisionHealth (formerly UCG); the Society of Interventional Radiology; and the Washington Examiner. A graduate of the College of Journalism at the University of Maryland College Park, she lives in Arlington, Va., with her husband and children.
Latest From Elizabeth Orr
Settlements Announced In Three “Electro-Acupuncture” False Claims Cases; Charges Filed Against Billing Consultant
Fraudsters have reportedly billed the government for the treatment, which uses electric impulses to replace the traditional needles of acupuncture.
The data supporting SurgiMend PRS ABDM isn’t enough to fully prove safety and effectiveness for that indication, the US FDA’s General and Plastic Surgery Devices Advisory Committee says.
Even research using leftover, deidentified specimens must be reviewed by an IRB, the US agency said in a letter to industry.
The recall is related to the software’s mixing parameters, which may cause false positives if test samples contaminate each other.
The recall is related to potential false positives that may occur if a genuine positive test sample overflows into an adjacent sample that would have otherwise tested negative.
The agency asked consultants Booz Allen Hamilton to evaluate its handling of diagnostic EUAs as a way to prepare for potential future pandemics.