Palm Beach, FL – December 14, 2022 – FinancialNewsMedia.com News Commentary – A cardiac arrhythmia is an irregular heartbeat caused by incorrect electrical signals that govern the beats of the heart. The improper signaling pathway causes the heart to beat too rapidly, which is tachycardia, or too gradually, which is bradycardia, or inconsistently. To avoid Cardiac arrhythmia issues, some treatments may involve medicines, implanted devices, catheter treatments, or procedures to regulate or eradicate fast, slow, or erratic heartbeats. A heart-healthy lifestyle can assist in the prevention of heart disease and arrhythmias. In addition, the cardiac arrhythmia monitoring devices helps in analyzing or recording the electrical activity of heart. These devices aid in diagnosing the cause and kind of irregular heartbeats. These technologies, which include remote patient monitoring, assist in the continuous monitoring of patients with cardiovascular arrhythmia. Continuous cardiac monitoring aids in the early detection and, as a result, successful intervention in patients suffering from cardiac arrhythmias.   A report from Acumen Research and Consulting projected that the Global Cardiac Arrhythmia Monitoring Devices Market size, which accounted for USD 6,485 Million in 2021 is expected to reach USD 11,490 Million by 2030 with a considerable CAGR of 6.8% during the forecast timeframe of 2022 to 2030.  The report said: “Recent innovations in cardiac arrhythmia monitoring devices, rising cardiovascular disease rates, favorable reimbursement rates for cardiac condition therapy, and a growing emphasis on healthcare cost containment are important drivers driving the cardiac arrhythmia monitoring devices market revenue. Furthermore, increased adoption of low-cost ECG services among the lower-income segment, as well as favorable government regulations for tech startups, are driving worldwide cardiac arrhythmia monitoring devices market trends.”    Active healthcare and tech stocks in news today include:  BioSig Technologies, Inc. (NASDAQ: BSGM), Medtronic plc (NYSE: MDT), iRhythm Technologies, Inc. (NASDAQ: IRTC), NeuroOne Medical Technologies Corporation (NASDAQ: NMTC), Ra Medical Systems (NYSE: RMED).

Acumen Research continued: “Modern scientific and technological developments in the category, as well as a spike in the proportion of older citizens suffering from cardiac difficulties, are all helping to drive the segment’s growth. Furthermore, the increasing prevalence of cardiovascular disease, the increasing proportion of outpatient hospital visits for diagnosis, the growing amount of cardiovascular implant treatments, and the accessibility of reimbursement for such treatments in developed markets all contributes to the size of this segment.”

BioSig Technologies, Inc. (NASDAQ: BSGM) BREAKING NEWS – BioSig’s PURE EP System Demonstrates Potential Time and Cost Savings at the 15th APHRS Scientific Session in Singapore  – Abstract highlights promising results from PURE EP study at premier Asia-Pacific Heart Rhythm Society Conference – BioSig Technologies (“BioSig” or the “Company”), an advanced digital signal processing technology company delivering unprecedented accuracy and precision to intracardiac signal visualization with its proprietary PURE EP System, today announced that its PURE EP System was featured in an abstract presentation during the 15th Asia Pacific Heart Rhythm Society (APHRS) Scientific Session in Singapore.

Results from the randomized study reveal the PURE EP System’s potential to promote shorter procedural times, and higher cost savings during catheter ablations. The study enrolled 29 patients with non-paroxysmal AF with post-ablation arrhythmia recurrence (“redo AF”). The primary objective was to determine the difference in procedural times when comparing ablations guided by PURE EP’s electrocardiogram (EGM) visualization to the conventional ECG recording system. Study results demonstrated that the PURE EP System led to a mean procedure time reduction of 11.3 minutes. Given an average EP lab cost is $37 per minute, the procedural time savings demonstrated by the PURE EP System suggests a cost savings of $418.10 per case. While this suggests that PURE EP promotes shorter procedural times, further studies are underway.

The abstract titled, “Reduced Time of Redo Atrial Fibrillation Ablation Procedures with PURE EP Recording System for ECG/EGM Visualization: A Randomized Study,” was presented as a poster presentation by Dr. G. Joseph Gallinghouse, Cardiac Electrophysiologist at St. David’s Medical Center in Austin, TX.

“With over 75,000 AF ablations performed in the US each year, the ability to demonstrate that PURE EP may reduce procedure times resulting in potential healthcare cost savings is a landmark milestone for the overarching value proposition of our technology,” said Gray Fleming, Chief Commercialization Officer, BioSig Technologies, Inc. “We believe a hospital can generate a meaningful return on investment in the first year of ownership of a PURE EP System. Additional studies demonstrating compelling clinical and economic value of the PURE EP System are in motion and we are looking forward to sharing these insights with the EP and healthcare community in the near future.”   CONTINUED…  Read this full press release for BSGM by visiting:  https://www.biosig.com/news-media/press-releases      

In other medical device / healthcare news of note:

NeuroOne Medical Technologies Corporation (NASDAQ: NMTC), a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, recently announced that it has successfully completed a feasibility study with its OneRF ablation system, a developing technology that utilizes existing implanted sEEG diagnostic electrodes for brain tissue lesioning.

The study evaluated the Company’s new RF ablation system in an animal model. The study used NeuroOne’s FDA cleared sEEG electrodes combined with a proprietary RF generator and a unique temperature control accessory that monitors and maintains the temperature at which the ablation is performed. This allows clinicians to set temperature and time for each ablation. Dr. Van Gompel and his team implanted five sEEG electrodes, performed electrophysiological recordings, and then completed a total of ten RF ablations using different settings for temperature and time. All ablations were confirmed by an MRI scan.

Catheter Precision, Inc., a medical device and technology company focused on cardiac electrophysiology, recently announced that more than 800 procedures have been performed in a number of leading U.S. and European hospitals utilizing the VIVO System that enables physicians to noninvasively identify an area of ventricular arrhythmia onset. On September 12, 2022 privately held Catheter Precision announced a definitive merger agreement with Ra Medical Systems (NYSE American: RMED), which, if completed, will result in a combined publicly traded company focusing on the cardiac electrophysiology market.

“We are always looking to the next milestone in clinical usage of our VIVO System and reaching 800 procedures by the end of 2022 was a goal we set earlier this year,” said David Jenkins, Catheter Precision CEO. “We are gratified by physician adoption so far through our strategic limited launch and look forward to expanding usage in 2023 by growing our sales and clinical support teams to access additional hospitals in new and existing territories. By expanding our footprint, we are bringing a valuable tool to electrophysiologists to help them gain a better understanding of patient anatomy and potentially improve outcomes while providing beneficial healthcare to more patients.”

iRhythm Technologies, Inc. (NASDAQ:IRTC), a leading cardiovascular diagnostics and digital healthcare solutions company focused on creating trusted solutions that detect, predict, and prevent disease, recently announced the results of four clinical studies presented at the American Heart Association’s (AHA) 2022 Scientific Sessions in Chicago, IL. The studies demonstrate health economic and clinical value of the Zio® AT and XT product lines across a range of diseases and clinical settings.

“The presented studies have important clinical implications,” said Dr. Mintu Turakhia, iRhythm’s chief medical officer and chief scientific officer. “First, screening for atrial fibrillation, based on the mSToPS trial, is cost-effective and can provide high value. Next, extended ambulatory ECG monitoring from our products, compared to shorter monitoring, more accurately estimates the burden of a common type of ventricular arrhythmia, which is clinically consequential to patients and important to get right. We also found that atrial fibrillation was an unexpected and important finding in patients who receive monitoring for loss of consciousness, which we already know benefits from Zio’s 14-days of ambulatory ECG monitoring compared to other diagnostics. Finally, we showed the potential for partnered healthcare system research with EHR integration, in this case for tailored care pathways for diverse populations.”

Medtronic (NYSE:MDT) recently announced the completion of enrollment and final treatment in the SPHERE Per-AF Trial, a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) pivotal trial designed to evaluate the safety and effectiveness of the first-of-its kind Sphere-9 pulsed field (PF) and radiofrequency (RF) ablation, and high density (HD) mapping catheter with the Affera cardiac mapping and navigation platform for the treatment of persistent atrial fibrillation (AF).

The investigational Medtronic technology includes the Affera mapping/navigation platform, designed to improve efficiencies by enabling intuitive HD mapping to diagnose arrhythmias and treat patients with one catheter. The Sphere-9 catheter combines mapping, navigation, and therapeutic capabilities and is the only catheter capable of delivering both RF and PF energies for ablation, providing physicians with the ability to customize treatment based on a patient’s needs during an ablation procedure.

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