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

Gratomic Announces Non-Brokered Private Placement21.7.2018 19:41Pressmeddelande

TORONTO, July 21, 2018 (GLOBE NEWSWIRE) -- Gratomic Inc. ("GRAT" or the "Company") (TSX-V:GRAT) (FRANKFURT:CB81) (WKN:A143MR) is pleased to announce the offering of a non-brokered private placement of up to 20,000,000 working capital units (the "WC Unit") for up to $2,000,000 (the "Offering"). Each WC Unit is priced at $0.10 and consists of one (1) common share and one (1) common share purchase warrant ("WC Warrant"). Each WC Warrant entitles the holder to purchase one (1) common share (a "WC Warrant Share") at a price of $0.20 per WC Warrant Share until the earlier of: (i) three (3) years following the Closing of the Offering; and (ii) in the event that the closing price of the Common Shares on the TSX Venture Exchange is at least $0.30 for ten (10) consecutive trading days, and the 10th trading day (the "Final Trading Day") is at least four (4) months from the Closing Date, the date which is thirty (30) days from the Final Trading Day. Eligible Finders may receive 5% of the value of

eGain Enables Conversational Customer Service Through Apple Business Chat20.7.2018 12:30Pressmeddelande

SUNNYVALE, Calif. and NEWBURY, United Kingdom, July 20, 2018 (GLOBE NEWSWIRE) -- eGain (NASDAQ:EGAN), the leading provider of cloud-based customer engagement solutions, today announced its integration with Apple Business Chat. According to Gartner, requests for customer support through consumer mobile messaging apps will exceed requests for customer support through traditional social media by 2019*. Moreover, 56% of consumers surveyed in a Nielsen study would rather message a business than call customer service, and 67% expect to message businesses even more over the next two years. Key capabilities Among key capabilities of the integrated solution are: Enabling hundreds of millions of consumers on iPhone and iPad to interact with businesses through the Messages app Leverage eGain AI to infer customer intent, power bot conversations through messaging, route escalations to contact center agents, and guide agents through messaging conversations Provide immersive customer experiences with

Marcus Hiles - Texas Takes #1 Four Years in a Row in America's Top States for Business19.7.2018 23:39Pressmeddelande

DALLAS, July 19, 2018 (GLOBE NEWSWIRE) -- The future business scene in Texas is looking brighter than ever as the state continues to hold its place as a national leader. Growth is spreading across areas such as North Texas, Houston and San Antonio with businesses quickly expanding their operations in the state that offers some of the best in business-friendly climates and overall growth potential. Tapping into the market recently are global leaders such as Toyota, Liberty Mutual and JP Morgan who have taken advantage of the state's increasing network of commercial properties, workforce and business resources. Named by CNBC for the fourth consecutive year as America's Top State for Business, Texas scored above all 50 states on overall business competitiveness. With the business hub building on its role as a national leader for the past decade, this top rank title reflects the progress Texas has made in cementing its place in the global economy. "This national recognition comes without s

Second Quarter 2018 Results Conference Call19.7.2018 21:34Pressmeddelande

AURORA, Ontario, July 19, 2018 (GLOBE NEWSWIRE) -- Magna International Inc. (TSX:MG) (NYSE:MGA) SECOND QUARTER 2018 RESULTS CONFERENCE CALL WEDNESDAY - AUGUST 8th, 2018 7:30 AM ET DIAL IN NUMBERS North America Toll Free: International Toll: Webcast: 1-888-223-4641 1-416-981-9080 www.magna.com Slide presentation will be available on our website prior to the call. REBROADCAST INFORMATION Replay available 2 hours after the call until August 15, 2018 North America Toll Free: International Toll: Reservation No.: 1-800-558-5253 1-416-626-4100 21892829 INVESTOR CONTACT Louis Tonelli, Vice-President, Investor Relations louis.tonelli@magna.com, 905-726-7035 TELECONFERENCE CONTACT Nancy Hansford, Executive Assistant, Investor Relations nancy.hansford@magna.com, 905-726-7108 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 originali

Uganda National Airlines Company Limited Signs Firm Order for Four Bombardier CRJ900 Aircraft19.7.2018 18:36Pressmeddelande

First operator of the new CRJ Series ATMOSPHÈRE cabin in Africa MONTREAL, July 18, 2018 (GLOBE NEWSWIRE) -- Bombardier Commercial Aircraft announced today that it has signed a firm order for four new CRJ900 regional jets with Uganda National Airlines Company. Based on the list price for the CRJ900 aircraft, the firm order is valued at approximately US$190 million. "We congratulate the Government of Uganda for the revival of its national flag carrier, and are thrilled that the new airline has selected Bombardier and the CRJ900 regional jets for its upcoming debut," said Jean-Paul Boutibou, Vice President, Sales, Middle-East and Africa, Bombardier Commercial Aircraft. "Recognized for its superior economics and efficiency, the CRJ Series aircraft have enabled airlines worldwide to serve communities with better connectivity, and we look forward to supporting the development of Uganda's regional air travel with these CRJ900 regional jets." Uganda Airlines will operate the CRJ900 in dual-cla

CrownBio Supports Excellence in Translational Research with Grant Award that Funds Innovative PDX Model Development in Immuno-Oncology19.7.2018 15:03Pressmeddelande

"Cancer Research Center of Lyon iPS novel PDX models formulate new immune cell focused strategies" SAN DIEGO, July 19, 2018 (GLOBE NEWSWIRE) -- Crown Bioscience, a global drug discovery and development services company providing translational platforms to advance oncology, inflammation, cardiovascular and metabolic disease research, is proud to announce the award of its Patient-Derived Xenograft (PDX) grant program to doctors Fabrice Lavial, Christophe Caux and Bertrand Dubois from the Cancer Research Center of Lyon (CRCL). The grant program was established to support oncology researchers pursuing scientific advancements in cancer using PDX technology. Following an extensive review, CrownBio's Scientific Steering Committee selected Dr. Lavial and his colleagues at the CRCL due to their project's potential to create breakthroughs in preclinical oncology strategies. Their research combines PDX and iPS cell technologies to create patient-specific, humanized models. These unique models wil

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

Besök vårt pressrum