Lepu Medical Technology (Beijing) Co. Ltd. has been given the green light from China’s NMPA for its disposable micro-guidewire. Beijing, China-based Lepu Medical confirmed to BioWorld that this micro-guidewire was approved for fractional flow reserve (FFR) measurements in adult patients with coronary artery lesions during coronary angiography and interventional procedures.
Lepu Medical Technology (Beijing) Co. Ltd. received marketing approval from China’s NMPA for its peripheral cutting balloon to treat peripheral arterial disease.
The FDA reported that Boston Scientific Corp. has recalled several models from the Ingenio line of cardiac electrophysiology devices in a class I action that affects 48,000 devices. The recall was triggered by the risk that these devices will inappropriately shift into safety mode and thus be unable to provide pacing, as demonstrated by 65 such incidents and three instances in which patients needed external pacing in response to the problem.
HONG KONG – A Chinese med-tech company plans to take to market what it claims is the first electrocardiography (ECG) diagnostic machine powered by AI, but as it moves to markets beyond China, it could face significant competition.
