This is the second FDA clearance in two weeks for Massachusetts-based Anumana. The company's AI models are built to evaluate ECG results for signs of various cardiovascular conditions.
In October, Harrison.ai submitted a citizen petition seeking greater flexibility in the 520(k) clearance process for certain computer-aided detection devices.
TTVR has made a major impact on heart patients all over the world. Just like aortic and mitral valve replacement, however, paravalvular leak is a serious complication that can lead to much worse outcomes.
The AI revolution in healthcare is less about technological advancement than change management vis-à-vis human relations. This may be nowhere more true than in critical care.
The pharmacy chain said it plans to appeal the ruling. The complaint was brought by a former employee turned whistleblower who alleged that Omnicare had billed the government for millions of unnecessary prescriptions.
According to the Wall Street Journal, the OIG and FBI are also involved in the DOJ's criminal probe into alleged incidents of upcoding by the Medicare Advantage insurer. UnitedHealth denied any wrongdoing.
