NASDAQ OMX

BioSig Announces Submission of FDA 510(k) Application for PURE EP(TM) System

Dela

SANTA MONICA, Calif., March 28, 2018 (GLOBE NEWSWIRE) -- BioSig Technologies, Inc. (OTCQB:BSGM) announced that the Company has filed 510(k) application to the U.S. Food and Drug Administration (FDA) for its first product, PURE EP(TM) System.

PURE EP System is a surface electrocardiogram and intracardiac multichannel recording system that acquires, processes and displays high fidelity cardiac recordings required during electrophysiology studies and catheter ablation procedures. The non-invasive PURE EP System is categorized as a Class II medical device according to the FDA and is subject to 510(k) performance standards and regulatory controls. The PURE EP System aims to minimize noise and artifacts and acquire high fidelity cardiac signals, which will potentially increase these signals' diagnostic value, and offer improved accuracy and efficiency of the EP studies and related procedures.

Atrial fibrillation is the most common arrhythmia currently affecting 33.5 million people worldwide, with 6.1 million people in the U.S. Atrial fibrillation increases the risk of stroke by 4 to 5 times and contributes to ca. 750,000 hospitalizations per year. The current market of EP is currently estimated at $4.6 billion and growing at 10.5% rate annually.

Between 2015-2018 BioSig has performed eleven pre-clinical studies at Mayo Clinic in Rochester, MN and one study at Mount Sinai Hospital in New York, NY. The results of these studies have been documented in seven peer reviews, including the Journal of Innovations in Cardiac Rhythm Management (JICRM) and the Journal of the American College of Cardiology (JACC).

In October 2017 BioSig announced the results of a nationwide survey of electrophysiologists. Survey respondents rated all six features of the PURE EP System as being 'Very Helpful' for their ablations, emphasizing overall 'noise' reduction and improved signal clarity/accuracy as key benefits.

In November 2017 BioSig engaged California based Sherpa Technology Group as its intellectual property advisors.

"Our Company's mission is to improve the standards of patient care worldwide. Submission of 510(k) application is a major milestone, which, once completed, will allow us to bring the PURE EP System to the EP community. Patient-centred innovation is at the heart of what we do, and we will continue to work rigorously to address unmet clinical needs," commented Kenneth L. Londoner, Chairman and CEO of BioSig Technologies, Inc.

About BioSig Technologies
BioSig Technologies is a medical device company developing a proprietary biomedical signal processing technology designed to improve the $4.6 billion electrophysiology (EP) marketplace (www.biosigtech.com). Led by a proven management team and a veteran, independent Board of Directors, Los Angeles-based BioSig Technologies is preparing to commercialize its PURE EP(TM) System.  The technology has been developed to address an unmet need in a large and growing market.

The Company's first product, PURE EP System, is a novel cardiac signal acquisition and display system which is engineered to assist electrophysiologists in clinical decision making during procedures to diagnose and treat patients with abnormal heart rates and rhythms. BioSig's main goal is to deliver technology to improve upon catheter ablation treatments for the prevalent and deadly arrhythmias, Atrial Fibrillation and Ventricular Tachycardia.

Contact:

Natasha Russkina
BioSig Technologies, Inc. 
VP Business Development & Corporate Finance 
nrusskina@biosigtech.com
+41 (0) 76 823 7527




This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: BioSig Technologies, Inc. via Globenewswire

Om

NASDAQ OMX
NASDAQ OMX



Följ NASDAQ OMX

Abonnera på våra pressmeddelanden.

Senaste pressmeddelandena från NASDAQ OMX

VITEC's EZ TV Video Wall Solution Wins Best of Show Award at the 2018 NAB Show26.4.2018 19:00Pressmeddelande

VITEC's EZ TV Video Wall Solution Wins Best of Show Award at the 2018 NAB Show SUNNYVALE, Calif., April 26, 2018 (GLOBE NEWSWIRE) -- VITEC, a worldwide leader in advanced video encoding and streaming solutions, today announced that the new EZ TV video wall processor, available within the award-winning EZ TV IPTV and Digital Signage Platform, was recognized with a Best of Show Award at the 2018 NAB Show from Sound & Video Contractor (SVC) magazine. Evaluated by a panel of industry experts, the Best of Show Award winners were selected based on innovation, feature set, cost efficiency, and performance in serving the industry. VITEC's video wall solution is designed to simplify deployment and management of projects involving IPTV, digital signage, and video wall content, while delivering a breathtaking visual experience. The new EZ TV video wall processors are 100 percent hardware-based, feature low-latency native playback of IPTV streams up to 4K, and support interactive content, video, a

Inspiration in Receipt of Crypto Currency Proposal26.4.2018 16:54Pressmeddelande

TORONTO, April 26, 2018 (GLOBE NEWSWIRE) -- Inspiration Mining Corporation ("Inspiration" or the "Corporation") (CSE:ISM) is pleased to announce that it is contemplating upon the request of Compassion Cannabis that it is allowed to accept crypto currency for settlement for any transactions that occur. The logic is that it would make for easy settlement in any jurisdiction. The Company is not adverse to this proposal, but must perform its due diligence and will table the matter at the AGM. Compassion Cannabis is an Ontario Corp., which has expertise to forward various facets of the explosive new market of the marijuana industry, including but not limited to the "Vape" market and dispensary centers for the industry. We believe this will be an extremely lucrative space with tremendous demand in the medical cannabis industry. For further information, please contact Randy Miller, Chief Executive Officer of the Corporation, at tel: 416-842-9000, www.inspirationmining.com The CSE has not revi

SNOMED International Announces Brazil as its 33rd Member26.4.2018 15:12Pressmeddelande

London, United Kingdom, April 26, 2018 (GLOBE NEWSWIRE) -- Brazil's Ministry of Health and SNOMED International announce that as of April 1, 2018, Brazil has joined the organization as SNOMED International's thirty-third Member. With SNOMED CT already used in various parts of the country, Brazil joined SNOMED International to support nationwide health system transformation as a foundational element of its ehealth Strategy, digiSUS. As outlined in this national strategy, the SUS Monitoring and Evaluation Department of Brazil's Ministry of Health is responsible overall for governance of the National Electronic Health Strategy and its related evaluation and development. Demonstrated through its membership in SNOMED International, Brazil has defined SNOMED CT as the chosen international reference terminology for use in its clinical systems supporting the national ehealth strategy. SNOMED CT is the world's most comprehensive health terminology. Founded in 2007 by nine charter nations, SNOME

Minerva Neurosciences to Report First Quarter 2018 Financial Results and Business Updates on May 3, 201826.4.2018 14:30Pressmeddelande

Management to host conference call WALTHAM, Mass., April 26, 2018 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced that it will release financial results and business updates for the first quarter of 2018 on Thursday, May 3, 2018. The Company will host a webcast and conference call that day at 8:30 a.m. Eastern Time to discuss these results and updates. The live call may be accessed by dialing (877) 312-5845 for domestic callers or (765) 507-2618 for international callers and referring to conference ID number 8885379. A live webcast of the conference call will be available online in the Investors and Media section of the Company's website at ir.minervaneurosciences.com. The archived webcast will be available on the Company's website beginning approximately two hours after the event for 30 days. About Minerva Neurosciences Mine

Talend Data Fabric Now Certified on MapR Converged Data Platform Version 6.026.4.2018 14:11Pressmeddelande

Latest Release of Talend's Data Integration Platform Enables Powerful New Use Cases in Data Privacy, Compliance Monitoring, Claims Processing, Retail Optimization, and More REDWOOD CITY, Calif., April 26, 2018 (GLOBE NEWSWIRE) -- Talend (NASDAQ: TLND), a global leader in cloud and big data integration solutions, announced that the latest version of Talend Data Fabric is now certified for version 6.0 of the MapR Converged Data Platform, including MapR-DB and MapR-FS. The MapR Converged Data Platform is the industry's only enterprise-grade software solution that unifies big data and open source technologies with fast, native access to global event streaming, real-time database capabilities, and web-scale storage. Together, Talend and MapR provide a unified, open source-based data storage and management platform for an array of different applications, enabling organizations to harness big data in valuable ways to drive innovation and further their digital transformations. "Talend's powerf

CrownBio Launches New Humanized Target Model for Immunotherapy26.4.2018 14:00Pressmeddelande

SAN DIEGO, April 26, 2018 (GLOBE NEWSWIRE) -- Crown Bioscience, a wholly-owned subsidiary of Crown Bioscience International (TWSE:6554) and a global drug discovery and development services company providing translational platforms to advance oncology, inflammation, cardiovascular and metabolic disease research, enhances its existing portfolio of humanized drug target models (HuGEMM(TM)) by launching a new transgenic CD3E model to advance development of immuno-oncology (I/O) drugs. Novel therapeutic T-cell redirecting antibodies, including bispecific T cell engagers, show great promise in effectively treating cancer. However, development of these drugs is hampered by a lack of in vivo models that can accurately recapitulate human specific responses. CrownBio addresses this need with their new CD3E transgenic model that was validated in collaboration with and developed by NBRI of Nanjing University. The CD3E model expresses the human form of CD3E and is phenotypically normal with levels

I vårt pressrum kan du läsa de senaste pressmeddelandena, få tillgång till pressmaterial och hitta kontaktinformation.

Besök vårt pressrum