Waltham, Mass.-based Thermedical Inc. has received a breakthrough device designation from the U.S. FDA for its saline enhanced radiofrequency (SERF) ablation system and Durablate catheter in the treatment of ventricular tachycardia (VT). The system uses a new means of biological heat to precisely deliver ablation therapy to the heart.
Edwards Lifesciences Corp. has gained a CE mark for its Pascal transcatheter valve repair system to treat tricuspid regurgitation (TR). It was previously approved for mitral regurgitation treatment. Due to the pandemic, Edwards has paused new enrollments in its ongoing mitral and tricuspid pivotal clinical trials.
Keeping you up to date on recent developments in cardiology, including: Robotic PCI reduces radiation exposure; COVID-19 and cardiovascular problems; Heart attack prevention falls short for stroke, PAD patients; Integrated herpesvirus-6 is pre-eclampsia risk factor.
BEIJING – Suzhou, China-based Peijia Medical Co. Ltd. became the second prerevenue med-tech company to go public on the Hong Kong Stock Exchange (HKEX) after Venus Medtech (Hangzhou) Inc., pocketing HK$2.3 billion (US$302 million) with an aim to develop and commercialize its transcatheter valve therapeutic medical device called Taurusone.
The U.S. FDA has given the greenlight to Eko Devices Inc.’s electrocardiogram (ECG)-based algorithm to aid in detecting patients with heart failure during the COVID-19 pandemic. The artificial intelligence (AI)-powered algorithm, which provides a quick way to screen for low ejection fraction, won FDA breakthrough status in December of 2019.
Keeping you up to date on recent developments in cardiology, including: Necklace used to detect abnormal heart rhythm; Link found between blood vessel inflammation, malfunctioning mitochondria; Liver-specific pre-eclampsia treatment is maternal-specific, as well.
Boston Scientific Corp. reported positive results for its Emblem subcutaneous implantable defibrillator (S-ICD) system and next-generation Watchman Flx left atrial appendage closure (LAAC) device at the Heart Rhythm Society scientific sessions, which were online only this year due to the COVID-19 pandemic.
Wearables giant Fitbit Inc. has kicked off its first large-scale, virtual study to evaluate how well its wrist-worn technology can spot episodes of irregular heart rhythm that might indicate atrial fibrillation (AF). The study, part of a broader plan to equip Fitbit devices with new tools to speed the detection of a range of conditions, is open to people in the U.S. ages 22 and older who own a Fitbit that tracks heart rate.
Zoll Medical Corp., of Chelmsford, Mass., received CE mark approval to market its second-generation Supersaturated Oxygen (SSO2) Therapy in Europe and other countries that accept CE mark. The therapy, which delivers hyperbaric levels of oxygen to the ischemic heart muscle immediately following percutaneous coronary intervention, has been shown to significantly reduce damage to the heart muscle after an acute myocardial infarction.
Keeping you up to date on recent developments in cardiology, including: Older siblings’ example turns stem cells into heart cells; Study: High blood pressure meds safe for patients, even during COVID-19 pandemic; COVID-19 spurs fast-tracking of heart, brain health research.