The FDA has granted a breakthrough device designation for Renovia Inc.’s digital therapeutic system Leva as a first-line treatment for chronic fecal incontinence (FI) in women. Fecal incontinence, also known as bowel leakage, is a progressive condition ranging from occasional leaks to a complete loss of bowel control. Common causes include diarrhea, constipation, and muscle or nerve damage that may be associated with aging or giving birth.

Asahi Intecc Co. Ltd. is tapping Hexagon Manufacturing Intelligence Inc.’s non-linear structural analysis software, Marc, to develop delivery devices that carry markers to the vicinity of cancers in preparation for endoscopic surgery.

PARIS – Defymed SAS reported the formation of the Decapes consortium, which brings together the Institute of Chemistry and Processes for Energy, Environment and Health (ICPEES) and the specialist microtechnology and biomaterials service provider for med-tech companies, Statice. This French consortium is working on a minimally invasive version of Defymed's Mailpan device, which will extend the application range for this artificial pancreas to include other chronic pathologies besides type 1 diabetes.

3D Systems Inc. acquired Volumetric Biotechnologies Inc. as part of its plan to expand its organ bioprinting program. The deal entails a $45 million upfront payment with an additional $355 million linked to meeting milestones “planned between now and 2035, and aligned with key points in the development process,” Volumetric President and CEO Jeffrey Graves told BioWorld. Houston-based Volumetric has focused on building replacement organs through bioprinting and created an approach that produces complex vasculature using light-based bioprinting.

TORONTO – Imaging company Moleculight Inc. has launched a new point-of-care, wound imaging platform intended for multiple U.S. health care settings and has also inked a deal with a U.S. distributor to ensure it gets there.

PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) is seeking comments from industry on mandatory reporting of medical device averse events by health care facilities, and the agency also published comments on a consultation on patient information to be provided with devices. As part of the recent overhaul of Australia’s medical device regulations, the TGA released an action plan for medical devices in 2019 that explored whether it should be mandatory for health care facilities to report adverse events and safety problems with devices to the TGA.