PALM BEACH, Florida, August 20, 2018 /PRNewswire/ --
MarketNewsUpdates.com News Commentary
Thedevelopment of the worldwide Electrophysiology market is being driven by a few elements, the most essential of which is the technological advancements. Technological developments and progressions of innovation have prompted the introduction of new products
BioSig Technologies, Inc. (OTCQB: BSGM) BREAKING NEWS - BioSig Technologies, after announcing last week that the Company has received 510(k) clearance for its first product, PURE EP System, from the U.S. Food and Drug Administration (FDA) the Company, a medical device company developing a proprietary biomedical signal processing platform designed to address an unmet technology need for the $4.6 billion electrophysiology (EP) marketplace, today announced that it has partnered with Mrs. Amy Ansfield Scott in order to assist with nationwide KOL engagement ahead of the commercial launch of PURE EP(tm) System in the U.S. Mrs. Scott brings to the Company over 30 years of experience in medical devices, including over 20 years in electrophysiology (EP). Most recently, she served as Director of Strategic Partnerships for Biosense Webster (Johnson & Johnson), a role which she was responsible for primarily U.S. engagement of physicians and management of the company's Scientific Advisory Board. Prior to that role, Mrs. Scott was managing a team responsible for driving customer engagement and education, including development of product demonstration and training sites, management of key accounts and liaison between internal clinical and field clinical trials teams. During her career with Biosense Webster, Mrs. Scott also served as Global Product Director for Atrial Fibrillation, the role in which she developed, executed and managed EP/Afib Centers of Excellence. She brings to BioSig extensive experience in defining customer needs and promoting key account relations and activities. "An experienced and passionate leader like Amy is an invaluable addition to our team. Her expertise in building successful physician relationships and the depth of her marketing knowledge can significantly benefit our effort to launch and expand our clinical operations following our 510(k) clearance," stated Mr. Kenneth Londoner, Chairman & CEO of BioSig Technologies, Inc. The Company announced that it received the 510(k) clearance for its PURE EP System on August 14, 2018. Earlier in the month, on August 1, 2018, the Company announced its intentions to list on the Nasdaq stock exchange. "I'm delighted to join the BioSig team as the Company starts a new chapter. I have been impressed with the strong value proposition of PURE EP and the long-term vision of the management team. I look forward to helping the Company make its first steps in the clinical field," commented Mrs. Scott. Read this and more news for BioSig Technologies at: http://www.marketnewsupdates.com/news/bsgm.html In other healthcare industry news of note:
Boston Scientific Corporation (NYSE:BSX) recently announced it has recently closed its acquisition of Claret Medical, Inc., a privately-held company that has developed and commercialized the Sentinel® Cerebral Embolic Protection System, the only device cleared to protect patients against the risk of stroke in transcatheter aortic valve replacement (TAVR) procedures. The company also announced that the U.S. Centers for Medicare and Medicaid Services (CMS) granted a New Technology Add-on Payment (NTAP) designation for the Sentinel System as part of the federal fiscal year 2019 Inpatient Prospective Payment System (IPPS). The NTAP designation, awarded to new medical devices determined to substantially improve the diagnosis or treatment of Medicare beneficiaries, will be effective on October 1, 2018.
Medtronic plc (NYSE:MDT) recently announced the online publication of `Effect of intrathecal baclofen on pain and quality of life in post-stroke spasticity: a randomized trial (SISTERS)` in Stroke: A Journal of Cerebral Circulation (Stroke). These results, secondary endpoints of the `Spasticity In Stroke-Randomised Study` (SISTERS) trial, demonstrate Intrathecal Baclofen Therapy (ITB Therapy(SM)) with Lioresal® Intrathecal (baclofen injection) reduces spasticity-related pain and improves quality of life more than conventional medical management (CMM) with oral antispastic medications. "Despite its known benefits, ITB Therapy continues to be underused when it comes to treating severe spasticity in post-stroke patients," said lead author and study investigator Michael Creamer, D.O., of Central Florida Pain Relief Centers in Orlando, Fla. "These secondary study results demonstrate that, in addition to treating excessive muscle tone associated with spasticity, ITB Therapy also addresses spasticity-related pain and quality of life and should be considered when assessing treatment options for post-stroke spasticity."
The Janssen Pharmaceutical Companies of Johnson & Johnson (NYSE:JNJ) announced recently the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) and a Type II Variation to the European Medicines Agency (EMA) seeking approval of a split dosing regimen for DARZALEX® (daratumumab). The applications seek to update the Prescribing Information and Summary of Product Characteristics to provide health care professionals with the option to split the first infusion of DARZALEX® over two consecutive days. The submissions are supported by data from the Phase 1b MMY1001 clinical trial, which demonstrated DARZALEX® pharmacokinetics (PK) concentrations were comparable regardless of whether the first dose was administered as a split infusion or single first infusion in patients with multiple myeloma. The safety profile of DARZALEX® was comparable when administered initially as a split or single dose. "We are committed to exploring options that may improve the administration profile of DARZALEX® and the overall treatment experience for patients and physicians," said Craig Tendler, MD, Vice President, Clinical Development and Global Medical Affairs, Janssen Research & Development, LLC.
In an article published by MD+DI Qmed, the FDA recently cleared Abbott Laboratories' (NYSE:ABT) Advisor HD Grid mapping catheter with the company's Sensor Enabled technology. The company said the Advisor HD Grid employs a new design that allows physicians to see things differently, capturing and analyzing data in a new way to create highly detailed maps of the heart that better differentiate healthy tissue from unhealthy tissue. The new mapping catheter builds on Abbott's other cardiac mapping technologies, including the EnSite Precision system that the company inherited through its acquisition of St. Jude Medical. According to Abbott, the Advisor HD Grid is designed to capture information that is often missed with standard mapping catheters, such as the direction and speed of cardiac signals. The device offers a unique grid configuration intended to capture this information and enable the creation of high-density maps of cardiac tissue to support optimal treatment for patients, the company said.
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