Glucotrack has submitted an IDE application to the US FDA, seeking approval to begin a clinical study in the US for its CBGM technology.
With FDA clearance in hand, Rivanna highlighted that it will accelerate the development of further AI capabilities for the Accuro XV system.
Entrepreneur and investor Eyal Lifschitz reflects ahead of his session at Biomed Israel on how emerging technologies are redefining what medtech is - and what they can become.
The uplifted FY26 outlook reflects a reversal on Q1 FY26, in which BD trimmed its outlook due to impacts from the sale of its diagnostics unit to Waters.
Roche has signed a definitive merger agreement for the acquisition of US-based PathAI in a deal valued at up to $1.05bn.
ArteraAI Breast is designed to stratify breast cancer patients into high- and low-risk groups to guide treatment decisions.
BD and Wellstar Health System have formed a partnership to enhance the safety and efficiency of medication delivery throughout Wellstar’s hospitals and care facilities.
Medtronic has received the CE mark for its VitalFlow Transport Frame AG, which functions as an accessory to the VitalFlow ECMO system.
VVeno Medical has received the IDE approval from the US FDA for a pivotal study involving a non-surgical replacement venous valve.
Avatar’s software translates CT and MR imaging data into 3D images to streamline surgical planning and operating room workflows.
Xtant Medical Holdings has commercially launched Trivium Shaped allograft, a new addition to its Trivium bone graft range for surgeries.
Insulet has commenced patient enrolment in its pivotal EVOLVE study, evaluating a fully closed-loop AID system for adults with T2D.
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