In a letter dated May 20, a number of medical associations and physicians groups ask the OCR to force UnitedHealth Group to follow through on notifying patients that their data was taken by hackers.
The Class I recall, which is the most serious recall the FDA issues, comes after numerous adverse events and complications linked to the radiographic markers were reported.
UPDATED: The alert pertains to the BioZorb and BioZorb LP radiographic markers, implanted in soft tissue to indicate the site for radiation therapy or other medical procedures.
New research out of Cleveland Clinic explored long-term outcomes among patients with moderate aortic stenosis who were treated with TAVR, SAVR or clinical surveillance. TAVR and SAVR were both associated with clear improvements compared to surveillance alone.
The MiniMed 780G automated insulin delivery system. Image courtesy of Medtronic/MiniMed.
The FDA-approved device includes meal detection technology that can deliver insulin when users lose track of time or underestimate how a meal may affect their health.