Author: Ken Dropiewski

Acutus Medical® Receives FDA Clearance for Advanced Cardiac Mapping Technology for Complex Arrhythmias

CARLSBAD, Calif., Oct. 24, 2017 /PRNewswire/ — Acutus Medical® today announced that the U.S. Food and Drug Administration has cleared the AcQMap® High Resolution Imaging and Mapping System and the AcQMap® 3D Imaging and Mapping Catheter for use in patients for whom electrophysiology procedures have been prescribed. The Company plans to introduce initial commercial systems […]

4C Medical’s Novel Mitral Regurgitation Therapy to be Presented at TCT 2017 Shark Tank Innovation Competition

BROOKLYN PARK, Minn., Oct. 24, 2017 /PRNewswire/ — 4C Medical Technologies, Inc. (4C Medical), a developer of minimally invasive technologies for structural heart disease, today announced that its medical device for mitral regurgitation (MR) will be highlighted in the Shark Tank Innovation Competition at the Transcatheter Cardiovascular Therapeutics (TCT) meeting held October 29-November 2, […]

Sub-Lite-Wall® StreamLiner™ Series Poised to Become New Design Standard for Improved Access in Catheter Delivery

ORANGEBURG, S.C., Oct. 24, 2017 /PRNewswire/ — Zeus Industrial Products Inc. (“Zeus”) has released its latest thin-walled PTFE catheter liner as part of their Sub-Lite-Wall® StreamLiner™ series. StreamLiner™ XT, the first offering from the series, was released in July with an impressive maximum wall thickness of 0.00075″ (0.01905 mm). The next in the series, […]

Inari Medical Announces Completion of Patient Enrollment in the FLARE Study for the Treatment of Pulmonary Embolism

IRVINE, Calif., Oct. 24, 2017 /PRNewswire/ — Inari Medical, Inc., a privately held venture backed medical device company dedicated to the development of innovative catheter-based technologies for the treatment of venous thromboembolism (“VTE”), announced today it has completed enrollment of its Investigational Device Exemption (“IDE”) study. The FlowTriever Pulmonary Embolectomy Clinical Study (“FLARE”) […]

BioSig Technologies Adds Role of Manufacturing Project Leader as Company Continues to Advance Towards Commercialization

Minneapolis, MN, Oct. 24, 2017 (GLOBE NEWSWIRE) — BioSig Technologies(OTCQB: BSGM), a medical device company developing a proprietary platform designed to address an unmet technology need for the $4.6 billion electrophysiology (EP) marketplace, today announced that the Company has engaged Quintain Project Solutions LLC as the manufacturing project management leader for […]

Coming soon: Spotlight on image-guided patient care at SIR 2018

FAIRFAX, Va., Oct. 23, 2017 /PRNewswire-USNewswire/ — Online registration is open for the Society of Interventional Radiology (SIR) 2018 Annual Scientific Meeting. The meeting takes place March 17–22, 2018, at the Los AngelesConvention Center in Los Angeles, Calif. SIR 2018 brings together more than 5,000 interventional radiology physicians, fellows, trainees and related health care professionals to explore […]

Surmodics Announces First Patient Enrolled in TRANSCEND Pivotal Clinical Trial for SurVeil® Drug-Coated Balloon

EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (Nasdaq: SRDX), a leading provider of medical device and in vitro diagnostic technologies, today announced enrollment of the first patient in TRANSCEND, the pivotal clinical trial for the SurVeil® drug-coated balloon (DCB). The randomized trial will evaluate the SurVeil DCB for treatment for peripheral artery disease (PAD) in […]

Abbott Launches the First and Only Smartphone Compatible Insertable Cardiac Monitor in the U.S.

ABBOTT PARK, Ill., Oct. 23, 2017 /PRNewswire/ — Abbott (NYSE: ABT) has secured U.S. Food and Drug Administration (FDA) clearance for the Confirm Rx™ Insertable Cardiac Monitor (ICM), the world’s first and only smartphone compatible ICM designed to help physicians remotely identify cardiac arrhythmias. With FDA clearance Abbott can now provide U.S. patients a new […]

Micro Interventional Devices Continues Clinical Success of MIA Technology

NEWTOWN, Pa., Oct. 23, 2017 /PRNewswire/ — Micro Interventional Devices, Inc. announced today the second successful implantation of its MIA (Minimally Invasive Annuloplasty) technology. The patient was enrolled in the first arm of the STTAR (Study of Transcatheter Tricuspid Annular Repair) clinical trial studying the safety and efficacy of MID’s MIA device […]