{"id":14890,"date":"2024-11-25T17:14:17","date_gmt":"2024-11-25T09:14:17","guid":{"rendered":"https:\/\/flcube.com\/?p=14890"},"modified":"2024-11-25T17:14:19","modified_gmt":"2024-11-25T09:14:19","slug":"microport-scientific-corp-s-bonafire-receives-nmpa-approval-as-first-whole-body-mri-safety-pacing-electrode-lead","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=14890","title":{"rendered":"MicroPort Scientific Corp.’s BonaFire Receives NMPA Approval as First Whole-Body MRI Safety Pacing Electrode Lead"},"content":{"rendered":"\n

Shanghai-based medical device giant MicroPort Scientific Corp. (HKG: 0853<\/a>) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its whole-body magnetic resonance imaging (MRI) condition safety pacing electrode lead, BonaFire. This marks a significant milestone, as BonaFire becomes the first product of its kind in China.<\/p>\n\n\n\n

Fast-Track Approval for Innovative Medical Device<\/strong>
The product was granted marketing approval with fast-track status in China as an innovative medical device. This status is reserved for products that demonstrate significant innovation and potential to improve patient outcomes. BonaFire’s approval process was supported by controlled clinical trials conducted across 18 clinical centers in the country, which provided evidence of the product’s safety and efficacy.<\/p>\n\n\n\n

Clinical Trials and System Safety<\/strong>
The clinical trials evaluated not only the BonaFire pacing electrode lead itself but also the MRI condition safety of the entire pacing system it is a part of. The successful trials demonstrated that the system, including BonaFire, meets the rigorous safety standards required for use in MRI environments.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

Shanghai-based medical device giant MicroPort Scientific Corp. 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