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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
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
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
The FDA, Health Canada and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) have jointly published guiding principles that lay the foundation for predetermined change control plans (PCCP) for machine learning enabled medical devices. Read More
While it might seem obvious, achieving effective corrective and preventive action (CAPA) plans requires diligence and consistent application of three core elements. Read More
With one in four medical devices incorporating some form of medical device software (MDSW), the European Council’s Medical Device Coordination Group (MDCG) has issued a guidance on the regulatory pathway or conformity assessment for the hardware or hardware components that comprise these devices. Read More