The U.S. organ donation system is once again under pressure from both the executive and legislative branches thanks to media reports detailing an instance in which a surgeon refused to harvest organs from a potential donor who had not expired.

Deepqure Inc. gained clinical trial clearance from South Korea’s Ministry of Food and Drug Safety to test its Hyperqure renal denervation system for the treatment of atrial fibrillation.

Plexāā Ltd. recently raised $4.5 million to support the upcoming U.S. launch of Bloom43, its wearable device that helps patients prepare for breast cancer surgery and reconstruction by using a technique called supraphysiological preconditioning.

The U.K. Medicines and Healthcare Products Regulatory Agency unveiled another round of measures designed to promote access to the latest medical technology, which includes a move to jettison domestic device markings in favor of unique device identifiers.

The U.S. FDA expanded the approval for use of Boston Scientific Corp.’s Watchman Flx and Watchman Flx Pro left atrial appendage closure (LAAC) devices to include post-ablation patients, bringing good news to the company as it preps for its second quarter earnings report on July 23.

Directsens GmbH recently signed a collaboration agreement with Metage, an Austrian research consortium, to advance a test for the early detection of type 2 diabetes. The focus of the partnership will be on validating Directsens’ Xpressgt assay, which measures 2-hydroxybutyrate levels in venous blood, and could be used by clinicians to inform patients they are at risk of developing type 2 diabetes.