PALM BEACH, Florida, October 19, 2017 /PRNewswire/ --
The medicaldevice sector continues to expand and grow as a result of physicians making the formative decision whether you need medicine or a medical device such as a pacemaker, an implantable cardioverter defibrillator (ICD), cardiac ablation or surgery, which
BioSig Technologies, Inc. (OTCQB: BSGM), a medical device company developing a proprietary platform designed to address an unmet technology need within the emerging electrophysiology (EP) marketplace, announced today that they have made significant progress towards commercialization of their proprietary PURE EP System. The 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. The Company recently received the first production units of the PURE EP System from its manufacturing partner. In addition to ongoing testing and development with current partners, BioSig has been demonstrating this system to select industry leaders. Additionally, they announced that Mr. Joseph W. Rafferty has joined BioSig Technologies and will serve as Chief Commercialization Officer. Joe adds more than 30 years of experience to BioSig and has assisted with the successful launch of a number of new technologies into the medical marketplace working for Johnson & Johnson, Boston Scientific, and CR Bard. Read this and more news for BioSig Technologies at: http://www.marketnewsupdates.com/news/bsgm.html BioSig management is currently preparing a 510(k) submission to the Food & Drug Administration (FDA) for commercialization in the U.S., and planning its European regulatory process with the National Standards Authority of Ireland (NSAI) which serves as the Notified Body to obtain the CE Mark. CE marking is a mandatory conformity marking for certain products sold within the European Union. Allied Market Research projects that the global Electrophysiology Market is expected to reach $8.2 billion by 2022, recording a CAGR of 13.4% during the period 2016-2022. The market is driven primarily by growth in incidence of atrial fibrillation, one of the most common heart rhythm disorder or cardiac arrhythmia, and an aging baby boomer generation with high-risk of targeted diseases. Mr. Kenneth Londoner, CEO & Chairman of BioSig Technologies, Inc. commented, "Management is confident that we established a strong foundation for future growth while completing the tasks required to achieve commercialization. Our novel technology, coupled with our strategic management hires and long standing clinical relationships have positioned us to bring our PURE EP System to the global EP market in 2018. Going forward, we will continue to establish and leverage strategic relationships that will assist in the development and sale of our proprietary systems to this vastly underserved market."
In other healthcare industry news of note:
Johnson & Johnson (NYSE: JNJ) this week reported sales of $19.7 billion for the third quarter of 2017, an increase of 10.3% as compared to the third quarter of 2016. Operational sales results increased 9.5% and the positive impact of currency was 0.8%. Domestic sales increased 9.7%. International sales increased 10.9%, reflecting operational growth of 9.3% and a positive currency impact of 1.6%. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide, domestic and international sales each increased 3.8%.* Net earnings and diluted earnings per share for the third quarter of 2017 were $3.8 billion and $1.37, respectively. Third-quarter 2017 net earnings included after-tax intangible amortization expense of approximately $0.9 billion and a charge for after-tax special items of approximately $0.5 billion. Third-quarter 2016 net earnings included after-tax intangible amortization expense of approximately $0.2 billion and a charge for after-tax special items of approximately $0.2 billion. Excluding after-tax intangible amortization expense and special items, adjusted net earnings for the current quarter were $5.2 billion and adjusted diluted earnings per share were $1.90, representing increases of 11.2% and 13.1%, respectively, as compared to the same period in 2016.* On an operational basis, adjusted diluted earnings per share also increased 10.1%.* A reconciliation of non-GAAP financial measures is included as an accompanying schedule. Read the full release here: https://finance.yahoo.com/news/johnson-johnson-reports-2017-third-104000829.html
Abbott Laboratories (NYSE: ABT) closed up slightly on Wednesday with over 9 million shares traded by the market close as was up slightly in afterhours trading. Earlier in the week, the company announced the U.S. launch of the company's Proclaim™ DRG Neurostimulator System, a new device designed to deliver stimulation to the dorsal root ganglion (DRG) and alleviate pain in patients suffering from complex regional pain syndrome (CRPS) of the lower limbs. With the Proclaim DRG system, Abbott has added new, patient-centric benefits to a device capable of delivering the company's sustained and superior pain relief for patients battling CRPS. Using Bluetooth® wireless technology, iOS‡ software and a more intuitive Apple‡ iPod touch‡ mobile digital device as the system's controller, the Proclaim DRG system is designed to provide patients new benefits over traditional neurostimulation systems. The Proclaim DRG platform is magnetic resonance (MR)-conditional and recharge-free, offering upgradeability and increased battery capacity over Abbott's previous generation systems.
Merck & Co. Inc. (NASDAQ: MRK) closed up slightly on Wednesday with over 7.8 million shares traded by the market close. The company recently announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a supplemental New Drug Application (sNDA) for the use of LYNPARZA® (olaparib) tablets in patients with germline BRCA-mutated (gBRCA), HER2-negative metastatic breast cancer (MBC) who have been previously treated with chemotherapy either in the neoadjuvant, adjuvant or metastatic settings. A Prescription Drug User Fee Act (PDUFA) date is set for the first quarter of 2018. This is the first submission for a poly ADP-ribose polymerase (PARP) inhibitor outside ovarian cancer and the third indication submission for LYNPARZA in the U.S. The sNDA is based on the positive results from the phase 3 OlympiAD trial published in the New England Journal of Medicine.
Boston Scientific Corporation (NYSE: BSX) News: Shifamed LLC, a privately held medical device incubator, announced that Apama Medical, Inc., a Shifamed Portfolio Company, was acquired by Boston Scientific Corporation for $175 million in cash up-front and a maximum of $125 million in contingent payments over the period of 2018-2020, based on achievements of clinical and regulatory milestones. Apama Medical has developed the Apama Radiofrequency (RF) Balloon Catheter System, a novel ablation catheter platform designed to combine the benefits of existing ablation technology, while incorporating additional unique features that address recognized unmet needs in the rapidly growing atrial fibrillation market. The Apama RF Balloon Catheter System is currently being evaluated in clinical studies and offers the potential to improve both procedural efficiency and control of the ablation therapy delivered.
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