November 21, 2018 — BTG plc announced the first Ekos CU 4.0 units have been shipped from BTG’s facility in Bothell, Wash ...

Medical artificial intelligence (AI) company Bay Labs and Northwestern Medicine announced that the first patient has been enrolled in a first-of-its-kind study. The study will evaluate the use of Bay Labs’ EchoGPS cardiac ultrasound guidance software to enable certified medical assistants (CMAs) as medical professionals with no prior scanning experience to capture high-quality echocardiograms. The study will also evaluate the use of its EchoMD measurement and interpretation software suite to detect certain types of heart disease among patients 65 years and older undergoing routine physical examinations in primary care settings.

The U.S. Food and Drug Administration (FDA) is proposing to add an exception to informed consent requirements for certain FDA-regulated clinical investigations that present no more than minimal risk to human research participants.

GE Healthcare announced it is recalling its Millennium Nuclear Medicine Systems due to an incident in which the the top detector detached and fell onto the detector below it. No patient injuries have been reported, although there remains a risk of potential life-threatening bodily harm if the detector were to detach and fall during a patient exam. The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall.

The U.S. Department of Health and Human Services (HHS) released the second edition of the Physical Activity Guidelines for Americans at the American Heart Association’s (AHA) 2018 Scientific Sessions, Nov. 10-12 in Chicago. The second edition — announced at AHA by Adm. Brett P. Giroir, M.D., assistant secretary for health — provides evidence-based recommendations for youth ages three through 17 and adults to safely get the physical activity they need to stay healthy.