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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
In two pivotal phase 3 trials, data showed that Glaukos’s combination product iDose TR succeeded in reducing intraocular pressure (IOP) safely. Read More
The FDA has issued a final guidance for laboratories and manufacturers on its policy for reviewing emergency use authorization of tests to diagnose monkeypox, bypassing the draft guidance stage. Read More
Three-year results continue to show that Abbott’s Amplatzer Piccolo Occluder, which was approved by the FDA in 2019, is safe and effective in nonsurgically closing a hole in the heart of premature infants. Read More
AposHealth’s Apos biomechanical knee treatment helped most patients suffering from disabling osteoarthritis (OA) to be able to delay knee replacement surgery for 24 months, according to data from an observational study published in the journal Population Health Management. Read More