Author: Ken Dropiewski

Artio Medical Successfully Completes Enrollment of First-in-Human Trial Investigating the Amplifi™ Vein Dilation System

Novel vein dilation system aims to improve vascular access for hemodialysis patients Prairie Village, KS – July 14, 2021 – Artio Medical, Inc., a medical device company developing innovative products for the peripheral vascular, neurovascular, and structural heart markets, announced today it has completed enrollment in its first-in-human study evaluating the […]

Baylis Medical Announces First Clinical Use of the VersaCross® Large Access Solution to Deliver Large Bore Therapy Solutions

TORONTO, July 29, 2021 /PRNewswire/ – Baylis Medical announced today the first clinical use of the VersaCross® Large Access Solution. The new solution includes the world’s first 3-in-1 RF wire paired with a seamless shapeable dilator designed to optimize tissue dilation for large sheath procedures, including left atrial appendage closure, transvenous mitral […]

Bardy Diagnostics Carnation Ambulatory Monitor Patch decreases both time to diagnosis and readmissions in Emergency Department patients with possible arrhythmia concerns in Clinical Study from Overlake Medical Center

BELLEVUE, Wash., July 29, 2021 /PRNewswire/ — A recent clinical study from Overlake Medical Center utilizing the Bardy Diagnostics Carnation Ambulatory Monitor (CAM) patch was presented at the 2021 Heart Rhythm Society (HRS) Conference. The abstract, “Accelerating Proper Evaluation of Emergency Department Patients for Arrhythmia Concerns with Discharge Use of ECG Patch Monitors,” […]

CryoLife Announces Sale of PerClot to Baxter

ATLANTA, July 29, 2021 /PRNewswire/ — CryoLife, Inc. (NYSE: CRY), a leading cardiac and vascular surgery company focused on aortic disease, announced today that it has completed the sale of its PerClot product line to a subsidiary of Baxter International, Inc. (“Baxter”) (NYSE: BAX ), for up to $60.8 million in cash. Of the $60.8 million, CryoLife will receive […]

Biofourmis Earns FDA’s First-Ever Breakthrough Device Designation for a Novel Digital Therapeutic for Heart Failure

BiovitalsHF® Approved for Expedited FDA Review Process as a First-in-Class DTx for Heart Failure that Augments Traditional Guideline-Directed Medical Therapy BOSTON, July 29, 2021 /PRNewswire/ — Biofourmis, a Boston-based global leader in virtual care and digital therapeutics, announced today its BiovitalsHF® solution is the first-ever heart failure digital therapeutic to receive a Breakthrough Device […]

Teleflex Reports Second Quarter 2021 Results and Full Year Outlook

WAYNE, Pa., July 29, 2021 (GLOBE NEWSWIRE) — Teleflex Incorporated (NYSE: TFX) (the “Company”) today announced financial results for the second quarter ended June 27, 2021. Second quarter financial summary Reported revenues of $713.5 million, up 25.8% year-over-year; up 21.0% on a constant currency basis GAAP diluted EPS from continuing operations of […]

Surmodics Announces Successful First Patient Use of Pounce™ Thrombectomy System

Standalone arterial mechanical thrombectomy device removes 30 cm of subacute thrombus in first clinical case EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ: SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, today announced that J. Michael Bacharach, MD, vascular interventionalist/cardiologist at North Central […]

Medtronic Announces FDA Clearance and Results of Artificial Intelligence Algorithms for Cardiac Monitoring

AI Algorithms Enhance LINQ II™ Insertable Cardiac Monitor Diagnostic Accuracy for Improved Management of Patients DUBLIN, July 28, 2021 /PRNewswire(opens new window)/ — Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced U.S. Food and Drug Administration (FDA) clearance for two AccuRhythm™ AI algorithms for use with the LINQ II™ […]

BIOTRONIK’s Implantable Cardiac Monitor Receives Prestigious Industry Award

BIOMONITOR IIIm Received Frost & Sullivan’s ‘Enabling Technology Leadership Award’ 2021 for its High Precision Implantable Cardiac Monitoring BERLIN, July 28, 2021 /PRNewswire/ — In association with Heart Rhythm 2021, BIOTRONIK today announced that the latest implantable cardiac monitor (ICM), BIOMONITOR IIIm, has been recognized by internationally-renowned research analysts Frost & Sullivan as […]