The U.S. Food and Drug Administration (FDA) issued the final rule on “Human Subject Protection; Acceptance of Data from Clinical Investigations for Medical Devices.” The rule updates the FDA’s standards for accepting clinical data from clinical investigations conducted both inside and outside the United States to help ensure the protection of human participants, and to help ensure the quality and integrity of data obtained from these clinical investigations.

Deep learning startup company Aidoc announced what it calls the world’s first and only comprehensive, full-body solution utilizing artificial intelligence (AI) to help analyze computed tomography (CT) scans, highlighting medical findings for radiologists. The workflow-integrated solution offers support for radiologists covering areas such as the head, c-spine, chest and abdomen.

February 20, 2018 – Lexington Biosciences, Inc., a development-stage medical device company, announced the commencement ...

A late-breaking analysis of the landmark COMPASS study was presented at the 2018 International Stroke Conference (ISC), showing that people with chronic coronary artery disease (CAD) and/or peripheral artery disease (PAD) taking Xarelto (rivaroxaban) had fewer ischemic strokes compared to those taking aspirin alone. This analysis, which specifically examined patients from COMPASS who experienced a stroke, also found high-risk patients taking Xarelto plus aspirin had the largest reductions in stroke.

Claret Medical announced that since U.S. Food and Drug Administration (FDA) clearance in June 2017, its Sentinel Cerebral Protection System has been adopted by 50 U.S. centers as part of its controlled rollout. The company said that some institutions have adopted the device as an emerging standard of care in the U.S. to protect patients from the risk of stroke by capturing and removing debris associated with transcatheter aortic valve replacement (TAVR) before it travels to the brain. The novel system has been shown to significantly reduce the risk of stroke in the first three days after TAVR by more than 60 percent, according to Claret Medical.

February 16, 2018 — California’s Petaluma Health Center (PHC) was recently awarded a 2017 Healthcare Information and ...