Having already set expectations around the structured capture of medical device safety data, regulators are now ready to analyze related insights, and they expect device manufacturers to match this capability.
Patient Preference Information (PPI) guidance on when and what methods to use to collect and submit patient preference information (PPI) for a device to FDA.
In this part 1 of a 4-part series, we look at how the burden of digital transformation is impacting the entire healthcare ecosystem, and that while burnout in healthcare is most often framed around clinicians, it does not reflect where the full transformation work is actually being carried…or its impact across healthcare.
FDA final guidance titled Medical Devices with Indications Associated with Weight Loss – Premarket Considerations.
While off-label use may be permissible, contraindicated use still has a strong regulatory boundary as reinforced by FDA guidance finalized in 2025.
Neo-Tee T-Piece resuscitator is being removed due to a undersized spring in the controller.
Speed control circuit board issue that may cause the motor to be unresponsive to the user.
Use instructions updated for Varipulse ablation catheter due to a high rate of stroke or transient ischemic attack.
Today, the U.S. Food and Drug Administration (FDA) issued a safety communication to raise awareness about cybersecurity vulnerabilities in Contec CMS8000 patient monitors and Epsimed MN-120 patient monitors. These medical devices are used in health care and home settings for displaying information, such as the vital signs of a patient, including temperature, heartbeat, and blood pressure.
Health equity can provide equal opportunity for patients to achieve the best care possible. Medtech leaders from Boston Scientific, Sequel Med Tech, and ZEISS Medical Technology share how healthcare delivery, data transparency, and industry collaboration can provide more value to patients.