Nexsen Biotech Pty Ltd. developed a rapid diagnostic test for Group B Streptococcus, a highly prevalent and potentially fatal bacteria that is the single largest maternal health problem faced by pregnant mothers.

The device industry has been clamoring for legislation that would require Medicare coverage for FDA-designated breakthrough devices, a wish that is one step closer to fulfillment as of June 27.

Applaud Medical Inc. continues to file for protection for aspects of its BRIO Enhanced Lithotripsy System, an acoustic enhancer technology which aims to eliminate ureteral stones quickly, affordably, and without the need for general anesthesia or a fluoroscopy procedure that may be conducted in a physician’s office and other non-hospital setting.

In a 5-4 decision June 27, the U.S. Supreme Court scuttled a Purdue Pharma LP’s bankruptcy plan that would have discharged any claims against the Sackler family, which owned and controlled the company that made billions of dollars from its sales of Oxycontin (oxycodone).

Uromems SAS raised $47 million in a series C financing round for its Uroactive system, the first smart automated artificial urinary sphincter device to treat stress urinary incontinence. With the funds the company will be able to “tackle the last stage of our clinical trials before commercial launch,” Hamid Lamraoui, CEO and co-founder of Uromems, told BioWorld.

Agilemd Inc. received U.S. FDA clearance for its Ecart clinical deterioration suite, an artificial intelligence-powered software as a medical device that uses a machine learning algorithm to continuously evaluate the risk of a hospitalized patient’s death or transfer to intensive care based on 97 real-time variables.