Palm Beach, FL – June 30, 2021 – Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, and much research is devoted to this market. AF is responsible for most arrhythmia-related hospitalizations and leads to the greatest length of hospital stay associated with any disorder of the cardiac rhythm. According to a report from MarketsAndMarkets, AF is the most common arrhythmia diagnosed in clinical practices, affecting over 886,000 new people each year in Europe. By 2030, the number of people with AF is expected to increase by up to 70% of the population; by 2050, Europe is expected to have the highest number of patients with AF. In the US, AF affected between about 2.7 million to 6.1 million people in 2012; this is estimated to rise to 12.1 million by 2030. According to a study published in the Medical Journal of Australia in August 2015, the number of AF patients aged above 55 years in Australia is estimated to reach to over 600,000 cases by 2034. The rising incidence of these diseases will correspondingly drive the demand for EP procedures, which makes it a primary growth driver for the electrophysiology market. The Markets report also said that the global electrophysiology market is projected to reach USD 10.6 billion by 2025 from USD 6.8 billion in 2020, growing at a CAGR of 9.1% from 2020 to 2025. Active healthcare and tech stocks in news today include: BioSig Technologies, Inc. (NASDAQ: BSGM), Medtronic plc (NYSE: MDT), Acutus Medical (NASDAQ: AFIB), iRhythm Technologies, Inc. (NASDAQ: IRTC), Stereotaxis (NYSE: STXS).
Technological advancements; new entrants in the market; growing investments, funds, and grants; and increasing incidence of target diseases and procedures are responsible for the significant growth of the market during the review period. The report continued: “Based on type of product, the EP laboratory devices market is segmented into 3D mapping systems, EP recording systems, RF ablation systems, intra-cardiac echocardiography (ICE) ultrasound imaging systems, EP X-ray systems, and other electrophysiology laboratory devices (MRI systems and EP remote magnetic and robotic navigation systems). 3D mapping systems accounted for the largest share of the global EP laboratory devices market in 2019. Driven by its high growth potential, markets players are increasingly focusing on the launch of new technologically advanced devices.”
BioSig Technologies, Inc. (NASDAQ: BSGM) BREAKING NEWS – BioSig Completes 1000 Patient Cases with its Signal Processing System for Electrophysiology – BioSig Technologies, a medical technology company commercializing an innovative biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals, today announced that physicians have completed 1000 patient cases with its technology across nine installation sites.
BioSig’s non-invasive computerized technology, the PURE EP
System, aims to drive procedural efficiency and efficacy in electrophysiology. The system provides essential diagnostic signals with high clinical value in all cardiac ablations that treat irregular heartbeats or arrhythmias.
Previously the Company increased the patient case goal from 1000 to at least 1500 procedures by the end of 2021, having delivered 425 procedures at the end of 2020. The Company is currently conducting patient cases in nine medical centers across the country. Texas Cardiac Arrhythmia Institute at St. David’s Medical Center in Austin, TX, Mayo Clinic Florida Campus, the Company’s first commercial customers, and the University of Pennsylvania count among the most prominent technology users with over 600 patient cases conducted to date.
“We are thrilled to cross the 1000-case milestone, a figure that was our initial target for the entire 2021. Most importantly, this case growth allows us to collect vast amounts of clinical data daily, providing us with immense intelligence that is vital for our clinical and commercial strategy. Increased technology usage in elective procedures is a much-awaited sign of the steady pandemic recovery in our country, and we are looking forward to a strong second half of 2021,” commented Kenneth L. Londoner, Chairman and CEO of BioSig Technologies, Inc.
The Company is in the targeted commercial launch phase, focusing on expanding its clinical footprint across the Northeast, Texas, and Florida, the three regions that account for the largest electrophysiology programs in the country. The Company recently expanded its commercial team by appointing Mr. Walt Quinn to lead regional sales in Florida. Mr. Quinn brings to the Company over 25 years of medical device and capital equipment sales experience in some of the leading companies in the field, including Ethicon (a Johnson&Johnson company), Medtronic, Topera (an Abbott company), and CardioFocus. CONTINUED… Read this full press release for BSGM by visiting: https://www.financialnewsmedia.com/news-bsgm/
In other medical device news of note:
Acutus Medical (NASDAQ: AFIB), an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, recently announced FDA approval for the company to initiate its Atrial Fibrillation (“AF”) Investigational Device Exemption (IDE) clinical trial for the AcQBlate Force Sensing Ablation Catheter and System. In the US, AF ablation procedures total approximately 190,000 per year and are projected to reach 375,000 annually by 2025. This trial is expected to enroll 350 subjects in leading centers globally and will evaluate the safety and efficacy of the system in the treatment of both paroxysmal and persistent atrial fibrillation.
Designed specifically to provide consistent, effective therapeutic solutions during cardiac ablation procedures, the AcQBlate Force gold-tipped catheter and system shows physicians, in real-time, how much contact force is being applied to the heart during ablations. Studies have shown the utility of real-time contact force information in helping physicians guide safe and effective therapy, which may improve patient outcomes.
Medtronic plc (NYSE: MDT), the global leader in medical technology, recently announced the initiation of the DEFINE AFib study, the company’s first app-based research study. Using data collected from the LINQ family of insertable cardiac monitors (ICMs), the study aims to address unanswered questions around atrial fibrillation (AF) burden and its impact on patient outcomes, quality of life, and healthcare utilization. The first patients in the study were enrolled at Duke University Medical Center in Durham, N.C., by Jonathan Paul Piccini, M.D., MHS, FHRS, director of Cardiac Electrophysiology and associate professor of medicine at Duke UniversitySchool of Medicine, and at Florida Electrophysiology Associates in Atlantis, Fla., by Robert S. Fishel, M.D., founder of the practice and director of Electrophysiology at JFK Medical Center.
DEFINE AFib will be conducted remotely through the new Medtronic Discovery App in coordination with U.S. sites that collectively will enroll approximately 5,000 patients. Study participants will include patients age 22 or older who have a history of AF, an iPhone device (iOS version 13 or higher), and one of the LINQ family of ICMs, among other criteria. The study will incorporate both device data and patient-reported data derived from scheduled patient surveys and the HealthKit — coupled with electronic health record information about medications and previous cardiac procedures — to provide comprehensive, actionable insights. Through a machine learning approach, aggregated study data will be leveraged to enable improved AF management in the future.
iRhythm Technologies, Inc. (NASDAQ: IRTC), a leading digital healthcare solutions company focused on the advancement of cardiac care, recently announced two new 510K clearances – one for a new and improved design of its flagship monitor and a second for updated artificial intelligence (AI) capabilities. The new Zio monitor is designed to significantly improve patient comfort while the advancements to its AI capabilities will further improve rhythm and beat diagnostic accuracy. The clearances demonstrate the company’s ongoing commitment to improving the patient and provider experience – by investing in next-generation capabilities across its diagnostic platform.
“iRhythm’s new Zio monitor and enhanced AI further illustrates our commitment to raising the standard of cardiac care for the providers and patients we serve,” said Mike Coyle, CEO of iRhythm. “By improving patient comfort and experience we can continue to maximize patient compliance, which is an essential element for collecting high-quality data for analysis. And with the power of our next generation AI, we can help physicians better identify, diagnose and manage a wide array of significant arrhythmias, including atrial fibrillation.”
Stereotaxis (NYSE: STXS), the global leader in innovative robotic technologies for the treatment of cardiac arrhythmias, recently reported financial results for the first quarter ended March 31, 2021. “The highlight of the first quarter is Stereotaxis’ return to robust double digit revenue growth with 50% topline growth,” said David Fischel, Chairman and CEO. “The results reflect the initial impact of the first wave of our strategic innovation plan.”
“During the quarter two robotic systems were shipped to hospitals establishing new robotic electrophysiology practices, triggering partial revenue recognition of those systems. Since the quarterly results two months ago, we received an additional purchase order for a robotic system in the United States.”
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