Author: Ken Dropiewski

Medtronic Announces First Procedures in Pivotal Trial to Evaluate Novel Ablation Technology in Treating Atrial Fibrillation

Study Will Determine the Safety and Effectiveness of Pulsed Electrical Fields to Interrupt Irregular Heart Rhythms DUBLIN, March 4, 2021 /PRNewswire/ — Medtronic plc (NYSE: MDT), the global leader in medical technology, today announced the first procedures in the investigational device exemption (IDE) pivotal trial to evaluate the PulseSelect™ Pulsed Field Ablation (PFA) System, a […]

MedAlliance Receives Fourth FDA Breakthrough Device Designation for Sirolimus Drug-Eluting Balloon in Treatment of De Novo Coronary Lesions

NYON, Switzerland, March 4, 2021 /PRNewswire/ — MedAlliance, the first drug-eluting balloon (DEB) company in the world to receive US Food and Drug Administration (FDA) Breakthrough Device Designation Status for a sirolimus DEB, has now been awarded breakthrough status for SELUTION SLR™, its sustained limus release DEB catheter, in the treatment of atherosclerotic lesions […]

Marizyme Announces New Distribution and Channel Partnership for Chilean Market with Abdera

JUPITER, Fla., March 4, 2021 /PRNewswire/ — Marizyme, Inc. (OTCQB:MRZM), a publicly traded global biotechnology company developing products to reduce the burden of ischemia-reperfusion injury in tissue grafting, organ transplant, and other surgical indications, announced today that it has entered into a supply and distribution agreement with Abdera Financial, Inc., a Chilean based distributor, […]

EchoNous Launches Continuous and Pulsed Wave Doppler on Kosmos Hand-Carried Hardware

Kosmos now offers first-of-its-kind “Hybrid HCU” device with unprecedented imaging and functionality aimed at workflow and patient care gains REDMOND, Wash., March 4, 2021 /PRNewswire/ — EchoNous, the leading developers of AI-driven, hand-carried ultrasound, today announced the addition of both continuous wave (CW) and pulsed wave (PW) Doppler capabilities to the Kosmos hardware […]

ControlRad® Announces FDA Clearance for ControlRad Select

ATLANTA, March 4, 2021 /PRNewswire/ — ControlRad, Inc., a privately held medical technology company focused on dramatically reducing unnecessary radiation exposure during fluoroscopically guided procedures, has announced the U.S. Food and Drug Administration (FDA) 510(k) clearance to market ControlRad Select. The technology utilizes proprietary semi-transparent filters, a user-interface tablet, and image processing algorithms, […]

Orsini Specialty Pharmacy Selected By Sarepta Therapeutics As A Limited Distribution Partner For AMONDYS 45 (casimersen)

ELK GROVE VILLAGE, Ill., March 4, 2021 /PRNewswire/ — Orsini Specialty Pharmacy, the leading independent specialty pharmacy focused on rare diseases and gene therapies, announced today that it has been selected by Sarepta Therapeutics, Inc. as a limited distribution partner for AMONDYS 45 (casimersen). AMONDYS 45 is indicated for the treatment of […]

BERLIN HEALS Announces results of first-in-human study for its Implantable C-MIC device for the Treatment of Heart Failure with Electrical Microcurrent and the Launch of a pivotal CE Mark Study

BERLIN and ZUG, Switzerland, March 04, 2021 (GLOBE NEWSWIRE) — BERLIN HEALS, a company dedicated to developing and offering novel and life-saving treatments for patients suffering from heart failure, announces results of a first-in-human study published in ESC Heart Failure, in patients with dilated cardiomyopathy for its proprietary C-MIC device. The […]

BioSig Awarded U.S. Patent Claims for its NeuroClear™ Subsidiary

Westport, CT, March 04, 2021 (GLOBE NEWSWIRE) — The patent is exclusively licensed from Mayo Foundation for Medical Education and Research Claims address methods and materials for improving the treatment of hypertension Fifteen additional licensed worldwide patent applications are pending, generally covering electroporation and stimulation BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or […]

Philips Incisive CT gets even smarter with debut of AI-enabled Precise Suite

New Precise Suite on the Philips Incisive CT platform accelerates CT workflows to help drive diagnostic confidence and improve the patient and staff experience Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced the launch of its AI-enabled Precise Suite [1] solution for […]

MEDCERT Enables the Use of the Single Access Procedure with Impella CP Introducer Sheaths in Europe

At Abiomed’s European headquarters in Aachen, Germany, Impella heart pumps have been developed and produced for more than 20 years to stabilize and recover the human heart. The single access procedure enables the treating physician not only to place Impella heart pumps in the ventricle via the 14 French Impella […]