Palm Beach, FL – November 4, 2021 – FinancialNewsMedia.com News Commentary – Atrial fibrillation is an ailment in which the heart beats irregularly, unlike the usual heartbeat. The upper chambers of the heart, the atria quiver in a very rapid pattern and thus the blood flow slows down or stagnates. The ventricles also beat unevenly and do not push blood around the body as efficiently. There is a growing amount of R&D to seek improvement in intracardiac signals and signal quality. Factors such as growing geriatric population and rise in medical tourism are expected to drive the growth of the market. According to the Centers for Disease Control and Prevention, more than 750,000 hospitalizations occur each year because of AFib in the US and the condition contributes to an estimated 130,000 deaths each year. Also, Increased incidence of risk factors such as obesity, hypertension, metabolic syndrome, and diabetes propel atrial fibrillation market growth.  In fact, a report from Market Research Future said that the market of atrial fibrillation is expected to grow significantly through 2023, where it is expected to reach USD 11.12 billion at a CAGR 11.2 % through 2023… While another report from iHealthcare Analyst is even more optimistic on market growth. It said the global market for atrial fibrillation predicted to attain $29.1 billion by 2027 growing at the rate of 11.4% CAGR, driven by increasing incidence and prevalence of disorders causing atrial fibrillation such as hypertension and obesity, rising geriatric population and age-related disorders.  The Market Research report continued: “Catheter ablation segment is projected to hold the largest share in the market, as it is a minimally invasive type of surgery which is the most preferred and used, as it lessens the risk of complications, whereas electric cardioversion is estimated to be the fastest growing segment because of its specificity of treatment and decreased recurrence rate.   Active healthcare and tech stocks in news today include:  BioSig Technologies, Inc. (NASDAQ: BSGM), Medtronic plc (NYSE: MDT), iRhythm Technologies, Inc. (NASDAQ: IRTC), Abbott (NYSE: ABT), Inspire Medical Systems, Inc. (NYSE: INSP).

Geographically, the Americas is anticipated to dominate the global atrial fibrillation market owing to a rise in the adoption of innovative technologies and procedures for the treatment of atrial fibrillation, and advanced healthcare facilities and infrastructure.  Europe is expected to hold the second largest position in the global atrial fibrillation market. The market growth in this region is attributed to the availability of funds for research, and favorable reimbursement scenario. According to a journal published by European Heart Network, approximately 10 million people in Europe live with the atrial fibrillation condition.  Asia-Pacific is anticipated to be the fastest growing region in the market due to the presence of a huge patient population susceptible to cardiac diseases, continuously developing economies and rising prevalence of cardiovascular diseases.

BioSig Technologies, Inc. (NASDAQ: BSGM) BREAKING NEWS – BioSig Expands its Installation Base in Texas – Signs a new installation agreement with high-volume center in San Antonio  – BioSig Technologies, a medical technology company commercializing an innovative signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals, today announced the Company is installing a PURE EP™ System for an evaluation at the Methodist Hospital in San Antonio, TX, one of the largest hospitals in the Unites States in terms of the number of available beds. This 90-day evaluation agreement brings the Company up to 15 installed centers.

“Texas is one of the three strategic areas that we are focusing on in the targeted commercial launch phase, and we are very pleased to welcome another Texas center to our customer base. Methodist Hospital conducted over 1800 cardiac ablations last year, and some of our greatest accomplishments have been achieved at similarly high-volume centers. We look forward to bringing our technology to more physicians in Texas to advance our clinical and commercial strategies further,” commented Kenneth L. Londoner, Chairman, and CEO of BioSig Technologies, Inc.

To date, over 71 physicians have completed over 1600 patient cases with the PURE EP™ System across thirteen clinical sites. The Company is in a focused commercial launch of the PURE EP™ System in the Northeast, Texas, and Florida, and the technology is in regular use in some of the country’s leading centers of excellence, including the Mayo Clinic in Rochester, MN, and St. David’s Medical Center in Austin, TX.

Clinical data acquired by the PURE EP™ System in a multi-center study at Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Mayo Clinic Jacksonville and Massachusetts General Hospital was recently published in the Journal of Cardiovascular Electrophysiology and is available electronically with open access via the Wiley Online Library. Study results showed 93% consensus across the blinded reviewers with a 75% overall improvement in intracardiac signal quality and confidence in interpreting PURE EP™ signals over conventional sources.

One in 18 Americans suffers from a cardiac arrhythmia. Atrial fibrillation is the most common arrhythmia type, affecting over 33 million people worldwide, including over 6 million in the U.S. The number of people suffering from atrial fibrillation is expected to reach 8-12 million by 2050[1]. According to the Centers for Disease Control and Prevention (CDC), atrial fibrillation causes more than 750,000 hospitalizations in the U.S. each year, resulting in approximately $6 billion in healthcare spending annually[2].  CONTINUED…  Read this full press release for BSGM by visiting:  https://www.financialnewsmedia.com/news-bsgm/     

[1] Top 10 Things You should Know About Heart Rhythm; Scripps Health.

[1] Managing Atrial Fibrillation; Lisa Eramom MA, Medical Economics Journal, February 25, 2019, Volume 96, Issue 4

In other medica devicel / healthcare news of note:

iRhythm Technologies, Inc. (NASDAQ: IRTC), a leading digital healthcare solutions company focused on the advancement of cardiac care, recently commented on the Centers for Medicare and Medicaid Services (CMS) Calendar Year 2022 Medicare Physician Fee Schedule (MPFS) Final Rule. The Final Rule and accompanying Addenda were released on November 2, 2021, along with updated payment policies, payment rates, and other provisions for services furnished under MPFS on or after January 1, 2022.

In the Final Rule, CMS did not issue national pricing and continued carrier pricing for calendar year 2022 on Category I CPT codes 93241, 93243, 93245 and 93247 for extended external ECG monitoring, the relevant codes for the Company’s Zio XT service.

iRhythm and other industry participants have been working with Medicare Administrative Contractors (MACs) to establish pricing for these codes. iRhythm remains engaged with all of the MACs and is working with other industry participants to submit additional cost data on long-term continuous ECG monitoring for consideration to establish fair and appropriate local rates. iRhythm is evaluating the new information included in the Final Rule and its potential implications on discussions with the MACs. iRhythm cannot provide certainty at this time on the potential outcome of the discussions with the MACs or on the timing of any action to be taken.

Medtronic plc (NYSE:MDT), a global leader in healthcare technology, recently announced findings from a new study of the Patient Preferences for the Treatment of Hypertension. The findings will be presented later today during the “What’s Novel in Interventional Hypertension session” at the 33^rd Transcatheter Cardiovascular Therapeutics (TCT 2021) conference, the annual scientific symposium of the Cardiovascular Research Foundation.

Medtronic also announced the initiation of the SPYRAL AFFIRM study, evaluating the long-term safety, efficacy, and durability of the Medtronic Symplicity™ Renal Denervation System in real-world patients with uncontrolled hypertension and comorbidities such as diabetes, isolated systolic hypertension, and chronic kidney disease.

Inspire Medical Systems, Inc. (NYSE: INSP), a medical technology company focused on the development and commercialization of innovative and minimally invasive solutions for patients with obstructive sleep apnea, recently reported financial results for the quarter ended September 30, 2021.

Recent Business Highlights Were: Generated revenue of $61.7 million in the third quarter of 2021, a 72% increase over the same quarter last year; Achieved gross margin of 86.0% in the third quarter of 2021, an increase over the 85.5% reported in the same quarter last year; Activated 68 new centers in the U.S. in the third quarter of 2021, bringing the total to 603 U.S. medical centers providing Inspire therapy; and Created 11 new U.S. sales territories in the third quarter of 2021, bringing the total to 141 U.S. sales territories.

Abbott (NYSE: ABT) recently announced financial results for the third quarter ended Sept. 30, 2021: Third-quarter sales of $10.9 billion increased 23.4 percent on a reported basis and 22.4 percent on an organic basis, which excludes the impact of foreign exchange; Third-quarter GAAP diluted EPS was $1.17and adjusted diluted EPS, which excludes specified items, was $1.40, reflecting 42.9 percent growth versus the prior year; Abbott projects full-year 2021 diluted EPS from continuing operations on a GAAP basis of $3.55 to $3.65 and full-year adjusted diluted EPS from continuing operations of $5.00 to $5.10, reflecting growth of 38.4 percent at the mid-point versus prior year; In August, Abbott announced U.S. FDA approval of its Amplatzer^® Amulet^® device, which offers immediate closure of the left atrial appendage – an area in the heart where blood clots can form; In August, Abbott announced results of the company’s GUIDE-HF clinical trial, which showed Abbott’s CardioMEMS^®remote monitoring system can improve care for more patients living with heart failure. Abbott filed a Premarket Approval (PMA) supplement with the FDA for consideration of an expanded indication for CardioMEMS; In September, Abbott announced U.S. FDA approval of its Portico^® with FlexNav^® transcatheter aortic valve replacement (TAVR) system to treat people with symptomatic, severe aortic stenosis who are at high or extreme risk for open-heart surgery; and During the third quarter, Abbott acquired Walk Vascular, LLC, a commercial-stage medical device company with a minimally invasive thrombectomy system designed to remove peripheral blood clots.

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