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MedAlliance announced that its Selution SLR drug-eluting balloon (DEB) has gained a conditional FDA investigational drug exemption (IDE) for the treatment of coronary de novo lesions, which typically have been treated with stents.
The European Commission has extended the transition period for manufacturers to comply with the Medical Devices Regulation (MDR), citing the limited capacity of notified bodies to ensure “a successful transition to the new regulatory framework.”
The U.S. Patent and Trademark Office has granted Reperio Health a patent for the technology that powers its biometric health screening platform that delivers home-performed medical tests to a mobile app.
Know Labs has gained a patent for its “High Performance Glucose Sensor,” which the company plans to use to create the first non-invasive glucose monitor.
Israel-based portable dialysis devicemaker liberDi has received FDA clearance for its Digital Dialysis Clinic, which allows patients to have dialysis at home while being monitored by a telemedicine provider.