FDA approved the MicroTransponder Vivistim Paired VNS System to treat moderate to severe upper extremity motor deficits associated...
The FDA authorized the use of an additional dose of the Pfizer-BioNTech or Moderna COVID-19 Vaccines in certain immunocompromised...
FDA approves Wegovy (semaglutide) injection for chronic weight management in adults with obesity or overweight with at least one weight-related condition.
FDA authorized marketing of the first device that uses artificial intelligence to detect lesions in the colon during a colonoscopy.
Coronavirus (COVID-19) Update
FDA has authorized marketing of a new device intended for use as a short-term treatment of gait deficit due to mild to moderate symptoms from multiple...
BioFire Diagnostics LLC granted De Novo for its BioFire Respiratory Panel 2.1.
): FDA granted de novo for the EndoRotor System to resection (cut out) and remove necrotic (dead) tissue for patients with walled-off pancreatic necrosis.
This policy is intended to facilitate the safe single-user reuse of certain respirators for healthcare personnel during the COVID-19 public health emergency.
The FDA re-issues Emergency Use Authorization for certain filtering facepiece respirators.