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In a guidance set to go into effect immediately, the FDA has made permanent the enforcement policy for use of clinical electronic thermometers it set during the COVID-19 public health emergency. Read More
A new FDA guidance set to take effect immediately extends the agency’s COVID-era policies requiring supplementary submissions for certain modifications to a device approved under the premarket approval (PMA) or humanitarian device exemption (HDE) pathways. Read More
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
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 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