Author: Ken Dropiewski

scPharmaceuticals Inc. Reports First Quarter 2022 Financial Results and Provides Business Update

FDA assigns PDUFA action date of October 8, 2022 Continuing to ramp up commercial readiness activities in advance of an anticipated Q4 2022 launch of FUROSCIX®, if approved Ended Q1 with cash, cash equivalents, restricted cash and investments of $65.6 million BURLINGTON, Mass., May 16, 2022 (GLOBE NEWSWIRE) — scPharmaceuticals […]

FUJIFILM VisualSonics Launches the New Multi-modal Vevo F2 Imaging Platform for Preclinical Ultrasound

First to feature the full range of ultra-high to low frequency ultrasound capability TORONTO, May 16, 2022 (GLOBE NEWSWIRE) — FUJIFILM VisualSonics Inc., a world leader in ultra-high frequency ultrasound and photoacoustic imaging systems, has announced the launch of Vevo® F2, the world’s first ultra-high to low frequency (71MHz-1MHz) ultrasound and […]

Vesalio Announces Completion of Enrollment in it’s FDA Enabling Stroke Study

Nashville, TN (May 11, 2022) – Vesalio is excited to announce the completion of patient enrollment for the CLEAR1 FDA IDE study utilizing the NeVa™ thrombectomy platform. This is an important milestone for Vesalio to complete for entering the U.S. neurovascular market to treat patients suffering from acute ischemic stroke (AIS).  AIS […]

Medtronic receives FDA approval for latest generation drug-eluting coronary stent system

The Onyx Frontier™ drug-eluting stent offers an innovative delivery system and builds upon the acute performance and clinical data from the Resolute Onyx™ drug-eluting stent DUBLIN, May 13, 2022 /PRNewswire/ — Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced it received U.S. Food and Drug Administration (FDA) approval for the Onyx […]

Humacyte First Quarter 2022 Financial Results and Business Update

— Human Acellular Vessels™ (HAVs™) shipped to six hospitals in Ukraine for treatment of civilian and military vascular trauma injuries — — Strengthened leadership team with appointment of Shamik Parikh M.D., as Chief Medical Officer —  — Multiple scientific meeting presentations and publications highlighting clinical and preclinical HAV data — — Conference […]

Longeveron Inc. Provides Corporate Update and Reports First Quarter 2022 Financial Results

Conference call scheduled for 8:30 a.m. ET today MIAMI, May 13, 2022 (GLOBE NEWSWIRE) — Longeveron Inc. (NASDAQ: LGVN) (“Longeveron” or “Company”), a clinical stage biotechnology company developing cellular therapies for chronic aging-related and life-threatening conditions, today provided a business update and reported its financial results for the first quarter […]

Acutus Medical completes enrollment in IDE trial with its AcQBlate® FORCE Sensing Ablation System

CARLSBAD, Calif., May 13, 2022 (GLOBE NEWSWIRE) — Acutus Medical (Nasdaq: AFIB), an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, today announced successful completion of patient enrollment in the company’s AcQForce™ Flutter Investigational Device Exemption (IDE) clinical trial which enrolled 110 patients at […]

Neovasc Announces First Quarter Financial Results and Provides Corporate Update

VANCOUVER and MINNEAPOLIS, MN, May 12, 2022 (GLOBE NEWSWIRE) — via NewMediaWire — Neovasc Inc. (“Neovasc” or the “Company”) (NASDAQ, TSX: NVCN) today reported financial results for the quarter ended March 31, 2022. Recent Highlights ·       Achieved Q1 revenue of approximately $611,000, an increase of 35% over the same period in 2021, […]