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 modality uses a high volume of linens, gels and other disposable supplies that also can have a significant global carbon footprint in radiology, experts note.
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.
The faulty adapters must not be used. The devices, manufactured under the brand name AirLife, must be identified and quarantined because of the high risk of severe injury or death associated with the malfunction.
