Philips gets FDA warning letter
Philips Medical Systems North America of Shelton, CT, is responding to a warning letter from the Food and Drug Administration regarding its Integris 3000 family of vascular imaging and interventional x-ray systems. The letter claims that when the systems
Philips Medical Systems North America of Shelton, CT, is responding to a warning letter from the Food and Drug Administration regarding its Integris 3000 family of vascular imaging and interventional x-ray systems. The letter claims that when the systems are connected with a VCR, the high fluoroscopy mode may not fully comply with the fluoroscopic recording provisions of FDA regulations. Philips is investigating the letter's claims and plans to issue a corrective action. In the meantime, Integris 3000 users should make sure that the VCR is recording prior to using the high fluoroscopy mode, according to the company. Philips said that the letter does not affect its newer Integris 5000 products.
MRI Study at ARRS Raises Questions About Disparities in Detection of MASLD
May 3rd 2025New research revealed that Hispanic Americans with evidence of hepatic steatosis on MRI but no formal diagnosis of MASLD had over a fourfold higher risk of developing hepatocellular carcinoma in comparison to those who had a formal diagnosis of MASLD.
