Medical device companies are working to gain regulatory approvals and launch new catheter-based devices as the world slowly returns to normal after reeling from the COVID-19 pandemic. As of April 19, the FDA had approved 11 medical devices this year — two of them catheter-based. In comparison, the regulatory agency approved 19 devices by April 19 last year. However, […]
Cardiovascular
BioVentrix appoints Jim Dillon president and CEO
BioVentrix today said it appointed Jim Dillon as president and CEO. The co-founder of Reprieve Cardiovascular, Dillon led its financing and development of a therapy for acute decompensated heart failure. He has also held a number of leadership roles at St. Jude Medical, Abiomed, TherOx and InfraReDx. “Jim’s field-based leadership style, combined with his proven […]
AtriCure AFib treatment device wins FDA approval
AtriCure (NSDQ:ATRC) announced today that the FDA approved its EPi-Sense system for treating long-standing persistent atrial fibrillation (Afib). Mason, Ohio-based AtriCure’s EPi-Sense system demonstrated superiority in the Hybrid AF therapy arm compared to endocardial catheter ablation alone in the Converge clinical trial, according to a news release. AtriCure’s Hybrid AF therapy is a minimally invasive […]
CorWave touts ‘unprecedented’ study results
CorWave announced today that chronic in vivo studies of its implantable heart pump have proven “unprecedented” with strong results. Presenting at the annual meeting for the International Society for Heart and Lung Transplantation (ISHLT), CorWave touted the study as the first ever to demonstrate sensorless synchronization of a pericardial pump with the native heart for […]
Boston Scientific, Stryker may get extension on Medicare payments
CMS has issued a proposal for the 2022 fiscal year that would potentially help big medtech companies like Boston Scientific and Stryker. Released yesterday, the proposal for the Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long Term Care Hospital (LTCH) offers updated Medicare payment policies and rates for operating and capital-related costs of acute […]
Phoenix Cardiac wins CE mark for mitral regurgitation device
Phoenix Cardiac Devices announced that it received CE mark approval for its BACE device for treating functional mitral regurgitation (FMR). BACE (basal annuloplasty of the cardiac externally) is a novel modality for treating FMR and is touted as the only surgical device with long-term clinical data demonstrating significant benefit by addressing the root cause of […]
LivaNova rises on Street-beating Q1
LivaNova (NSDQ:LIVN) shares got a boost this morning on first-quarter results that beat the consensus forecast. LIVN shares were up 6.1% at $87.95 per share in early-morning trading today. The London-based company posted losses of -$29.7 million, or -61¢ per share, on sales of $247.6 million for the three months ended March 31, 2021, for […]
Integra Lifesciences ticks up before hours on Street-beating Q1 results
Integra LifeSciences (NSDQ:IART) today posted first-quarter results that beat the consensus on Wall Street. The company reported profits of $45.4 million, or 53¢ per share, on sales of $360.1 million for the three months ended March 31, for a bottom-line gain of 394.5% on sales growth of 1.62% compared with Q1 2020. Adjusted to exclude one-time […]
AtriCure beats the Street in Q1 results
AtriCure (NASDAQ:ATRC) posted first-quarter results today that beat the consensus forecast on Wall Street. The Mason, Ohio-based company reported losses of -$16.9 million, or -38¢ per share, on sales of $59.3 million for the three months ended March 31, for a sales growth of 11.37% compared with Q1 2020. Adjusted to exclude one-time items, earnings per […]
Abbott launches AI-powered coronary imaging platform in Europe
Abbott (NYSE:ABT) announced today that it launched its new coronary imaging platform in Europe as it is now CE marked. The platform, powered by Ultreon 1.0 software, merges optical coherence tomography (OCT) with AI to enhance visualization and detect the severity of calcium-based blockages and measure vessel diameter, according to a news release. The goal […]
Israel investigating heart inflammation cases in Pfizer COVID-19 vaccine recipients
Israel’s Health Ministry is researching “tens” of cases of myocarditis, or heart inflammation, in people who have received the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX). More than five million people in the country have received the vaccine. The agency, however, has not yet established a causal relationship between the events and the vaccine. Get the […]
