The U.S. Attorney’s Office for the Southern District of New York has indicted Laura Perryman, former CEO of Stimwave, a Florida-based medical device company, in connection with an alleged scheme for creating and selling a non-functioning medical device for implantation into patients suffering from chronic pain.
Baxter International announced that it issued an urgent medical device correction for potential patient oxygen desaturation, or low blood oxygen, under certain conditions when its Life2000 ventilation system is connected to a third-party oxygen concentrator.
The FDA has issued its first two replacement guidances — on face masks and face shields — of the 72 COVID-19-era guidances that automatically sunset after the expiration of the public health emergency on May 11.
The FDA has announced that when the COVID-19 public health emergency declaration expires on May 11, many of the 72 guidances issued to address the pandemic and that are still in effect will be revised and remain in effect, while others will be allowed to expire.
The FDA has cleared the first medical device under the agency’s Safer Technologies Program (STeP) — Endolumik’s fluorescence-guided gastric calibration tube, which uses near infrared light to allow surgeons to see the tube through the gastric wall during gastric and bariatric surgical procedures.