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Maryland-based Medcura announced that the FDA has granted the company’s LifeGel absorbable surgical hemostatic gel Breakthrough Device designation as a hemostatic agent to control bleeding during surgical procedures.
Previous treatment options adapted surgical devices developed for adults and this is the first device specifically cleared by the FDA for pediatric use, the company said.
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.