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CAREstream Medical drew an FDA Form 483 citing various failures in documentation following an agency inspection of the company’s Maitland, Fla., facility from April 25-27. Read More
South Korea’s Lunit INSIGHT CXR artificial intelligence (AI) system improved radiologists’ findings in chest X-rays in four abnormalities, according to study findings published in JAMA Network Open on Aug. 31. Read More
Planning for a drug or device recall, training for it and executing it with a heaping helping of humility are the key steps to managing a recall without sinking your business, according to Matt Walker, director of business development for the risk management company Sedgwick. Read More
Manufacturers ready to establish a risk-based framework for computer software assurance throughout the software’s lifecycle now have a clearer place to start. Read More
OssView, medical diagnostic software that calculates bone microstructural deterioration, has received Breakthrough Device Designation from the FDA, according to developer CurveBeam AI of Hatfield, Penn. The designation will give the investigational software a prioritized 510(k) application review. Read More
Political pressure and internet-bred conspiracy theories have eroded one of the FDA’s prime functions — the communication of scientific truth, FDA Commissioner Robert Califf said at the annual meeting of the Regulatory Affairs Professional Society (RAPS) taking place in Phoenix, Ariz. this week. Read More
The EU released last week a working draft of a manual to help devicemakers understand where the line between a device and another type of product falls and how devices are classified under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Read More
The FDA announced that Abbott has issued a recall notice for all versions of the heart valve repair device MitraClip Clip Delivery System in response to increased complaints about the device malfunctioning while locked. Read More