We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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.
The Biden administration has asked Congress for $7.2 billion in funding for the FDA for fiscal 2024 — an approximately 10 percent increase over what the agency received in fiscal 2023.
The FDA has released a final rule that updates the agency’s mammography regulations to address changes in technology and strengthen the FDA’s oversight of mammography facilities.