South Korea’s CU Medical Systems Inc. has applied for protection of a system that combines features of a cardiopulmonary resuscitation (CPR) device and an automatic external defibrillator (AED) and uses chest impedance measurements to optimize emergency treatment.

Armed with strong phase III safety data in Japanese patients, Palo Alto, Calif.-based Bridgebio Pharma Inc. is planning to file for Japan approval of its investigational drug acoramidis for a rare heart disorder.

Armed with strong phase III safety data in Japanese patients, Palo Alto, Calif.-based Bridgebio Pharma Inc. is planning to file for Japan approval of its investigational drug acoramidis for a rare heart disorder.

The controversy over the use of paclitaxel (PTX) in devices used to treat peripheral artery disease (PAD) has taken roughly half a decade to unwind as regulatory agencies across the globe stand down their restrictions on the use of these devices.

Royal Philips NV recently received some good news from the U.S. FDA which cleared its latest transesophageal echocardiography (TEE) ultrasound transducer, amidst ongoing efforts with the regulatory body to address problems with its sleep business. The X11-4t Mini 3D TEE transducer is 35% smaller than previous versions and is designed to provide cardiologists with high quality 3D images of the heart and its internal structure.

Edwards Lifesciences Corp. received some good news with the earlier-than-expected U.S. FDA approval of its Evoque tricuspid valve replacement system. The company beat out rival Abbott Laboratories for the honor of being the first transcatheter therapy to receive FDA approval.

Windtree Therapeutics Inc. has renewed its partnership with Chang Gung University to further research on SERCA2a, an important target for the company’s cardiovascular portfolio.

Researchers at the Spanish National Center for Cardiovascular Research (CNIC) have identified a new target that may open new avenues into pulmonary hypertension (PH) treatment. Their findings were published in Science Advances on Jan. 19, 2024.

The U.S. FDA added a second pulsed field ablation (PFA) system to the approved list with its greenlight for Boston Scientific Corp.’s Farapulse for treatment of atrial fibrillation (AF). Farapulse joins Medtronic plc’s Pulseselect, which garnered FDA approval in December. Two other PFA devices scored regulatory wins since the new year: Biosense Webster inc.’s Varipulse secured approval from the Japanese Ministry of Health Labor and Welfare and Sichaun Jinjiang Electronic Medical Device Technology Co. Ltd. got the nod from China’s National Medical Products Administration.