The U.S. FDA cleared Paragonix Technologies Inc.’s Kidneyvault portable renal perfusion system, which combines digital monitoring capabilities and hypothermic perfusion technology to preserve donor kidneys during transportation.

Preliminary results from a trial demonstrated that Science Corp.’s Prima retina implant restored ‘form vision,’ including the ability to read in patients with vision loss. Originally developed at Stanford University and then advanced by Pixium Vision SA, Prima received U.S. FDA breakthrough device designation in April 2023.

The recent uptick in med-tech deals is a sign technologies that are solving unmet clinical needs are finally coming to fruition, Antoine Papiernik, chairman and managing partner at Sofinnova Partners, told BioWorld in an interview.

Researchers from UCLA’s Department of Cardiac Surgery filed for protection of a smart multistage peripherally inserted cannula with active fixation for temporary cardiopulmonary support which simultaneously drains both sides of the heart.

Epitomee Ltd. happily swallowed the news of U.S. FDA clearance for its capsule for weight management, an ingestible medical device for adults who are overweight or obese. Designed for use along with diet and exercise, the capsule expands in the stomach to create a feeling of fullness that lasts up to six hours.

Elixir Medical Corp. reported positive 12-month data from the Infinity-Swedeheart trial that compared its Dynamx coronary bioadaptor system to Medtronic plc’s Resolute Onyx zotarolimus drug-eluting stent in patients requiring percutaneous coronary intervention with coronary artery disease.

Abbott Laboratories’ diabetes unit opened the month with a two-cannon salvo – a partnership with Beta Bionics Inc. that will integrate Abbott’s Freestyle Libre 3 Plus continuous glucose monitor with the Ilet Bionic Pancreas system and the roll out of its over-the-counter Lingo CGM in the U.S.

A decade ago, when Asia Pacific Medical Technology Chairman (APACMed) John Collings was running a medtech business in China, he was flying high with multiple rounds of investment under his belt and preparing to launch two new technologies, but the company hit a regulatory hurdle that delayed the launch and he found himself grappling for answers, he told the APACMed Forum held Sept. 5 in Singapore.

Researchers from the University of Arkansas have filed for protection of their development of systems and methods to aid angioplasty procedures in coronary artery bifurcations, where a major artery splits into smaller blood vessels.

In what represents the first patenting from Munich, Germany-based Meliodys Medical UG, its co-founder and chief executive officer Simone Sabbione describes their development of a hormone-free, local pain management approach for treating dysmenorrhea, which aims to address the condition while minimizing the occurrence of side effects.