Other News

Viz.ai Receives FDA 510(k) Clearance for Viz ANEURYSM

First AI-powered cerebral aneurysm detection solution designed to facilitate population screening and enhanced care management SAN FRANCISCO–(BUSINESS WIRE)–Viz.ai, the world leader in artificial intelligence (AI) powered care coordination, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for Viz ANEURYSM. The new algorithm uses AI to […]

Arena Reports Fourth Quarter and Full Year 2021 Financial Results and Key Program Updates

– Phase 3 ELEVATE UC 52 and 12 on course for Q1 2022 topline data readout February 23, 2022 04:05 PM Eastern Standard Time PARK CITY, Utah–(BUSINESS WIRE)–Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today provided a corporate update and reported financial results for the fourth quarter and full year ended December 31, […]

Penumbra, Inc. Reports Fourth Quarter and Full Year 2021 Financial Results

ALAMEDA, Calif., Feb. 22, 2022 /PRNewswire/ — Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today reported financial results for the fourth quarter and full year ended December 31, 2021. Financial Highlights: Revenue of $204.0 million for the fourth quarter of 2021, an increase of 22.2% compared to revenue of $166.9 million for the fourth quarter […]

Teleflex Receives FDA Clearance for Expanded Indication for Specialty Catheter and Coronary Guidewire Use in CTO PCI Procedures

Results of CTO-PCI IDE Study Demonstrate Procedural Success with Teleflex Specialty Catheters and Coronary Guidewires in Patients Undergoing Chronic Total Occlusion Percutaneous Coronary Interventions WAYNE, Pa., Feb. 23, 2022 (GLOBE NEWSWIRE) — Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced that the U.S. Food and […]

SyMap Medical Ltd Completed Enrollment in SMART Study for the Treatment of Uncontrolled Hypertension

SUZHOU, China, Feb. 23, 2022 /PRNewswire/ — SyMap Medical Ltd. (Suzhou, China) announced successful completion of enrollment in the company’s SMART Study (Sympathetic Mapping/Ablation Renal nerves for Treatment of hypertension Trial; NCT02761811), using the SyMapCath I™ Catheter/SYMPIONEER S1™ Mapping/RF System for the treatment of uncontrolled hypertension. This is the first pivotal study for registration purpose, worldwide, using […]

Saluda Medical Appoints Doug Godshall as Chairman of the Board

ARTARMON, Australia, Feb. 23, 2022 /PRNewswire/ — Saluda Medical Pty Limited (“Saluda Medical”), a global medical device company on a mission to revolutionize the field of neuromodulation with an emerging portfolio of therapies driven by advanced closed-loop technologies designed to treat debilitating neurological disorders, today announced the appointment of Doug Godshall as Chairman of its Board […]

Cytokinetics Announces Start of SEQUOIA-HCM, a Phase 3 Clinical Trial of Aficamten in Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy

Pivotal Trial to Assess the Potential of Aficamten to Improve Exercise Capacity, Heart Failure Symptoms and Functional Class SOUTH SAN FRANCISCO, Calif., Feb. 23, 2022 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that SEQUOIA-HCM (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM), a Phase 3 clinical trial of aficamten in patients with symptomatic obstructive […]

Liquidia Corporation Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

MORRISVILLE, N.C., Feb. 23, 2022 (GLOBE NEWSWIRE) — Liquidia Corporation (NASDAQ: LQDA) today announced the grant of an inducement stock option exercisable for an aggregate of 25,700 shares of Liquidia’s common stock to a newly hired non-executive employee under the Liquidia Corporation 2022 Inducement Plan (the “Inducement Plan”). The stock […]

Lantheus Receives U.S. FDA Approval of New Manufacturing Facility

On-site plant will produce DEFINITY® (Perflutren Lipid Microsphere), the leading diagnostic ultrasound enhancing agent for patients with suboptimal echocardiograms NORTH BILLERICA, Mass., Feb. 23, 2022 (GLOBE NEWSWIRE) — Lantheus Holdings, Inc. (the “Company”) (NASDAQ: LNTH), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial […]