Medtronic (NYSE:MDT) today announced the results of two successful clinical trials for its Melody transcatheter pulmonary valve (TPV) therapy. The Fridley, Minn.-based medtech giant virtually presented its 10-year outcomes at the 2020 Society for Cardiovascular Angiography & Interventions (SCAI) scientific sessions. Melody demonstrated strong long-term hemodynamic and safety outcomes, while the investigational Harmony TPV pivotal trial […]
How AI could help health providers diagnose COVID-19
When it comes to diagnosing treating COVID-19, timeliness is imperative to avoid patient deaths. Several companies are developing artificial intelligence-based algorithms to help doctors analyze and diagnose COVID-19 in patients quickly. The coronavirus has affected more than 3.7 million people globally, with the U.S. experiencing the most COVID-19 cases at just over 1.2 million so […]
Eko lands EUA for ECG-based algorithm for COVID-19 patients
Eko announced today that the FDA has issued the company an emergency use authorization (EUA) for its novel ECG-based algorithm designed to provide an easily accessible, rapid screening test for low ejection fraction (low EF), a weak heart pump. Awarded an FDA breakthrough device designation in December 2019, the algorithm’s regulatory review has been further […]
CardioFocus wins FDA approval for HeartLight X3 endoscopic ablation system
CardioFocus announced today that it received FDA approval for its next-generation HeartLight X3 endoscopic ablation system. Marlborough, Mass.-based CardioFocus’ system treats drug-refractory recurrent symptomatic paroxysmal atrial fibrillation (PAF). Last year, the company won CE Mark approval in Europe for the device and in February of this year, it announced that it sought out a PMA […]
AtriCure to raise $100m from public offering
AtriCure (NASDAQ:ATRC) said today that it commenced a public offering to issue and sell roughly $100 million worth of its common stock. The Mason, Ohio–based company — maker of treatments for atrial fibrillation (Afib) and left atrial appendage (LAA) management — said it plans to grant the underwriters of the offering a 30-day option to […]
Fitbit launches wearable AFib detection study
Fitbit (NYSE:FIT) recently announced it launched its first large-scale, virtual study to validate the use of its wearables in atrial fibrillation detection. The Fitbit Heart Study is part of Fitbit’s larger strategy to make easy-to-use tools for the detection of a range of conditions. The goal of the study is to enroll hundreds of thousands of […]
Genetesis completes $9.2m Series B
Cardiac imaging technology developer Genetesis announced today that it completed a Series B financing round worth $9.2 million. Significant investments from TDK Ventures and an undisclosed Fortune 500 company helped to complete the funding, according to a news release. Returning investors CincyTech, Ohio Innovation Fund and Mark Cuban also contributed. Mason, Ohio-based Genetesis develops the […]
Cardiovascular Systems sinks on missed Q1 revenues
Cardiovascular Systems (NSDQ:CSII) shares dropped today on COVID-19-affected first-quarter results that missed the consensus forecast. The St. Paul, Minn.-based company posted losses of -$2.9 million, or -8¢ per share, on sales of $61.2 million for the three months ended March 31, 2020, sliding into the red from profits of $672,000 year-over-year on a sales decline of […]
Cardiovascular societies outline return to medical, surgical procedures
A group of North American cardiovascular societies released guidance today on the resumption of heart-related procedures in light of the COVID-19 pandemic. The guidance, scheduled to be published in a future issue of the Journal of the American College of Cardiology, takes into account regional differences in the intensity of the outbreak. Most invasive cardiovascular […]
Zoll Medical wins CE Mark for oxygen therapy system
Zoll Medical announced today that it received CE Mark approval in Europe for its TherOx SuperSaturated Oxygen (SSO2) therapy system. SSO2 therapy offers interventional cardiologists a treatment beyond percutaneous coronary intervention (PCI) that significantly reduces muscle damage in heart attack patients. Chelmsford, Mass.-based Zoll’s therapy system delivers hyperbaric levels of oxygen directly to damaged heart […]
Terumo Aortic gains FDA breakthrough designation for aortic arch repair device
Terumo Aortic this week said it received FDA breakthrough device designation for its Thoraflex Hybrid stented device for complex aortic arch repair. Thoraflex Hybrid is a single-use device that combines a gelatin-sealed woven polyester graft with a Nitinol self-expanding stent graft. It is designed for the surgical repair or replacement of damaged or diseased aortic […]
