Xeltis AG reported the first-in-human results for its fully synthetic electrospun vascular access graft, showing 100% patency at six months in 20 patients with end stage renal disease who were not suitable for arteriovenous (AV) fistula creation. Read More
Dexcom Inc. posted a 19% increase in first quarter revenues compared to 2022 boosted by a stunning 27% organic growth in sales outside the U.S. With clearance of the G7 device in hand, another record set in new patient starts and coverage of continuous glucose monitoring (CGM) systems by CMS effective this month, the year is shaping up to be quite rosy for the diabetes device company. Read More
For several years, the U.S. CMS has been musing a coverage policy specifically for breakthrough medical devices, and the absence of activity on this front has once again drawn the attention of Congress. Rep. Cathy McMorris Rodgers (R-Wash.), said a representative of CMS had recently appeared before a House subcommittee for the first time in four years, and that the subcommittee is prepared to act on breakthrough devices coverage if CMS doesn’t produce a final rule this year. Read More
Cardiex Ltd. won U.S. FDA clearance for its Conneqt Pulse vascular biometric monitor. According to the digital health and wearables company, the device is the first in the world to provide measurements of both brachial blood pressure in the arm and central blood pressure in the heart and aorta, as well as arterial waveform analysis and other clinically relevant vascular biomarkers, outside the hospital, research institutions or clinical trial sites. Read More
Oso-AI SAS raised $10.7 million to develop its artificial intelligence (AI)-driven augmented ear for frail people and their caregivers. This series A financing round was led by its historical shareholders Innovacom SAS, Novinvest Partners SAS and Breizh-up, which is the co-investment fund of Brittany region financed by the European Regional Development Fund and managed by UI Investment SAS. Cemag Invest Partners SAS has joined these three historical investors. This operation follows a first round of financing of $4.4 million which closed in September 2020. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbott, CSI, Checkable Medical, Globus Medical, Greenlight Guru, HTEC Group, Nuvasive, Precipio, Proteomedix. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apyx Medical, Intuitive Surgical. Read More
