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In this edition of Quick Notes, we cover medical device clearances for GE HealthCare’s Allia IGS Pulse for cardiac imaging, Ventric Health’s Vivio system for heart failure diagnosis, the Ori by Masimo to analyze oxygen saturation and the TriLEAP anatomic plating system, a procedure-specific system designed for orthopedic clinicians. Read More
Seeking to address the growing problem of how misinformation undermines confidence in both science and the FDA, the Regan-Udall Foundation recently released a report focusing on how the FDA can deliver clear messaging to deliver improved understanding of the FDA and the products it regulates. Read More
As the first session of the 118th Congress continues, FDAnews will track important pending legislation that has been acted on since July 1, to keep you updated on laws and regulations that could impact your business. Read More
An upstream occlusion alarm in certain of B. Braun’s infusion pumps that may sound when no occlusion exists and cause the pump to stop pumping caused the company to issue a recall on Sept. 23, which the FDA has now deemed as class I, the most serious type of recall. Read More
In a win for Masimo, the U.S. International Trade Commission (ITC) banned the importation of Apple watches with light-based oximetry technology that monitors heart rate and blood oxygen because the watches violate two patents held by Masimo. Read More
Over the past week, the FDA issued draft guidance on communications of off label uses of approved/cleared medical products and remote inspections of drug manufacturing and BIMO facilities. Read More
In this edition of Quick Notes, we cover a Philips study confirming the safety of its cardiac diagnostic device, FTC action against deceptive marketing of a COVID-19 protection device, and updates to two FDA medical device event reporting databases. Read More
Fresenius Medical Care has recalled some of its hemodialysis machines for the potential of exposing patients to a harmful chemical, and Olympus has recalled an insufflation unit — and the FDA has deemed both these recalls as class I, the most serious type of recall because of the potential for serious side effects including death. Read More