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Puzzle Medical Devices Inc. Receives U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for Its Revolutionary Minimally Invasive Transcatheter Heart Pump

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MONTREAL, Feb. 8, 2021 /PRNewswire/ - Puzzle Medical Devices Inc., (
www.puzzlemed.com) announced today that the U.S. Food and Drug Administration (FDA) has granted the company a Breakthrough Device Designation for its revolutionary transcatheter pump to address heart failure.
The FDA Breakthrough Device Program is intended to help patients receive more timely access to certain medical devices that have the potential to provide more effective treatment for life-threatening or irreversibly debilitating diseases or conditions, including a prioritized review of market approval regulatory submissions.
The FDA s recognition of Puzzle Medical s heart pump as a Breakthrough Device is a testimony to the innovative and disruptive nature of this device, said Philippe Généreux, MD, interventional cardiologist at Gagnon Cardiovascular Institute, Morristown Medical Center, New Jersey, USA, and Chief Medical Officer of Puzzle Medical. This novel technolog ....

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Financial Institutions, Inc. Schedules Fourth Quarter and Full Year 2020 Earnings Release and Conference Call

Financial Institutions, Inc. Schedules Fourth Quarter and Full Year 2020 Earnings Release and Conference Call
Financial Institutions, Inc. Schedules Fourth Quarter and Full Year 2020 Earnings Release and Conference Call
WARSAW, N.Y., Jan. 06, 2021 Financial Institutions, Inc. (NASDAQ:FISI) (the “Company”), the parent company of Five Star Bank, SDN Insurance Agency, LLC (“SDN”), Courier Capital, LLC (“Courier Capital”) and HNP Capital, LLC (“HNP Capital”), will release results for the fourth quarter and full year ended December 31, 2020, after the market closes on January 28, 2021.
Management will host an earnings conference call and audio webcast on January 29, 2021 at 8:30 a.m. Eastern Time. The call will be hosted by Martin K. Birmingham, President and Chief Executive Officer, and Justin K. Bigham, Chief Financial Officer. The live webcast will be available in listen-only mode on the Company’s website at www.fiiwarsaw.com. Within the United State ....

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Kofax Announces ReadSoft Online Integration with Microsoft Dynamics 365 for Invoice & Accounts Payable Automation

Kofax Announces ReadSoft Online Integration with Microsoft Dynamics 365 for Invoice & Accounts Payable Automation
Kofax Announces ReadSoft Online Integration with Microsoft Dynamics 365 for Invoice & Accounts Payable Automation
Kofax, a leading supplier of intelligent automation software for digital workflow transformation, today announces the integration of ReadSoft Online, its software-as-a-service (SaaS) solution for invoice data extraction and accounts payable automation, with the Microsoft Dynamics 365 platform. The integrated solutions allow organizations to transform their procure-to-pay workflows and automate mission-critical processes.
Kofax and Microsoft share a vision of enabling accounts payable teams to accelerate their digital transformation initiatives, says Kathleen Delaney, Chief Marketing Officer at Kofax. The integration announced today illustrates how were delivering on that vision, helping our customers unify complex workflows, siloed systems and ....

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Small vessels can cause big problems; MagicTouch SCB Granted [...] | Comunicati stampa CataniaOggi

18 dicembre 2020 06:30
Fonte: Adnkronos
#salute-e-benessere
TAMPA, Fla., Dec. 17, 2020 /PRNewswire/ Concept Medical Inc. (CMI) has been granted Breakthrough Device Designation from the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) for the MagicTouch SCB Sirolimus Coated Balloon Catheter, for the treatment of small coronary artery lesions in Coronary Artery Disease (CAD).
The proposed indication for use includes The MagicTouch SCB Sirolimus Coated Balloon Catheter is indicated for percutaneous transluminal coronary angioplasty, after appropriate vessel preparation, of small coronary artery lesion lengths of 6 - 36mm in coronary arteries with reference vessel diameters of 1.50 - 2.75mm.
Each of the three main arteries supplying blood to the cardiac musculature, branches into progressively smaller vessels that eventually penetrate the cardiac musculature. Occlusion of these small vessels (coronary microvascular d ....

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Small vessels can cause big problems; MagicTouch SCB Granted 'Breakthrough Device Designation' for the treatment of Small Coronary Artery Lesions

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TAMPA, Fla., Dec. 17, 2020 /PRNewswire/ Concept Medical Inc. (CMI) has been granted Breakthrough Device Designation from the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) for the MagicTouch SCB Sirolimus Coated Balloon Catheter, for the treatment of small coronary artery lesions in Coronary Artery Disease (CAD).
The proposed indication for use includes The MagicTouch SCB Sirolimus Coated Balloon Catheter is indicated for percutaneous transluminal coronary angioplasty, after appropriate vessel preparation, of small coronary artery lesion lengths of 6 - 36mm in coronary arteries with reference vessel diameters of 1.50 - 2.75mm.
Each of the three main arteries supplying blood to the cardiac musculature, branches into progressively smaller vessels that eventually penetrate the cardiac musculature. Occlusion of these small vessels (coronary microvascular disease) can diminish blood flow to the heart leading to chest pa ....

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