This edition of Medtech Insight’s regular round-up of heart-tech news covers some highlights of this years’ Transcatheter Cardiovascular Therapeutics (TCT) meeting in September, including the latest trials of Abbott's Amulet left-atrial appendage closure device and Medtronic's Intrepid transcatheter mitral valve replacement.
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Fogarty Innovation Leads First TCT
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King’s College London, Imperial College London and The Alan Turing Institute constructed cardiac digital twins at scale, creating over 3,400, in a new study using UK Biobank data published in Nature Cardiovascular Research on 16 May.
The REFLECT studies showed a 78% reduction in cardiovascular disease-related hospitalization for people living with type 1 diabetes with prior low blood sugar episodes.
SS Innovations announced plans to file a de novo application with the US FDA for its SSi Mantra 3 surgical robot, already approved for marketing in six countries. The Florida-based firm also plans to pursue the CE mark for European commercialization.
“It’s quite likely [consumer wearable manufacturers] are changing the sensitivity and specificity based on consumer feedback, but not for medical reasons,” said Dipak Kotecha, a University of Birmingham professor of cardiology. Often, self-reported performance evidence from manufacturers is “low quality and biased.”
The REFLECT studies showed a 78% reduction in cardiovascular disease-related hospitalization for people living with type 1 diabetes with prior low blood sugar episodes.
Despite Danaher’s confident outlook, the company acknowledged near-term profitability fluctuations, particularly in the second quarter. Matt McGrew, Danaher’s CFO, clarified during the company’s first-quarter earnings call on 22 April, that expected operating margin softness in the second quarter – forecast at 25.5% – was not related to tariffs, but to seasonal dynamics in its respiratory diagnostics business.
After publishing encouraging results from first-in-human trials of its brain-computer interface, Axoft announced plans to sell its BCI-enabling material Fleuron to researchers and private organizations for R&D use. The company sees this as a revenue stream and feedback loop to refine its BCI platform designed for safer, longer-lasting brain implants.
