Device Malfunction Reports Prompt Recall of Embolic Protection System
The recall was initiated following reports of 9 device malfunctions.
Devices
FDA Approves Urethral Stricture Treatment Optilume
The Optilume device includes a balloon coated with paclitaxel.
Prescription Digital Therapeutic Cleared for IBS-Associated Abdominal Pain
Regulora is designed to provide seven 30-minute sessions of remote behavioral therapy based on gut-directed hypnotherapy.
FDA Clears AI Software Lunit INSIGHT MMG to Detect Breast Cancer
Lunit INSIGHT MMG is a deep learning based software that assists radiologists in analyzing mammograms.
Focused Ultrasound Device Approved for Advanced Parkinson Disease
Patients are awake and responsive during the whole treatment duration.
FDA Approves Device to Screen Women With Dense Breasts as Adjunct to Mammography
The device is not intended to be used as a replacement for screening mammography.
FDA Clears Add-On Device That Turns MDIs Into Smart Inhalers
The device is attached to the top of the canister of the patient’s inhaler and works together with the mobile app to monitor and provide feedback.
FDA: Risk of LAAO Implant-Related Adverse Events May Be Higher for Women
The analysis included 49,357 patients undergoing LAAO procedures with the Watchman Left Atrial Appendage Closure device.
FDA Clears VNS Device for Paroxysmal Hemicrania, Hemicrania Continua
Patients treated with gammaCore experienced clinically meaningful benefits.
Left Ventricular Assist Devices Aid Survival, Quality of Life in Elderly
Benefits for heart failure patients include functional capacity and fewer complications with newer devices
