Palm Beach, FL – February 11, 2021 – Cardiovascular devices are the medical devices which are used to diagnosis and treat the heart diseases and other heart-related problems. These devices play essential role prevention and treatment of cardiovascular diseases. The cardiovascular devices include implantable cardioverter defibrillators, implanted heart rhythm monitors, pacemakers, and various other devices. The cardiovascular devices market is currently witnessing considerable demand across the globe. Increasing awareness about the various cardiovascular diseases and increasing geriatric population across the world are the primary factors driving the growth of the market. As per the estimation of the World Health Organization (WHO), cardiovascular diseases are the number one cause for death globally and taking around 17.9 million lives every year. Thus, the rising prevalence of cardiovascular diseases is one of the key factors fueling the growth of the market. A report by FiorMarkets projected that the global cardiovascular devices market is expected to grow from USD 42.61 billion in 2019 to USD 71.05 billion by 2027, at a CAGR of 6.6% during the forecast period 2020-2027. Active healthcare and tech stocks in news today include: BioSig Technologies, Inc. (NASDAQ: BSGM), Medtronic plc (NYSE: MDT), Boston Scientific Corporation (NYSE: BSX), TransEnterix, Inc. (NYSE: TRXC), PAVmed Inc. (NASDAQ: PAVM).
The FiorMarkets report said that: “Cardiac devices control irregular heartbeats. It is beneficial for heart patients having a rhythm disorder. Heart disorders are caused by irregularity in the system when the heart contracts and pumps out the blood. Cardiovascular devices are used in the treatment or the diagnosis of cardiovascular disorder. It serves as a monitoring treatment, alleviation and prevention of diseases. The global cardiovascular devices market is driven by increased patients with chronic diseases related to heart. Also, change in lifestyle and food habits are resulting in increased demand for cardiovascular devices. Global cardiovascular devices market is increasing rapidly, owing to the rising incidences of the heart-related diseases across the globe. In addition to this, rising geriatric population in North America and the European region, further boosting the growth of the market. Moreover, increasing research and development activities to develop highly advanced cardiovascular devices, also propelling market growth.”
BioSig Technologies, Inc. (NASDAQ: BSGM) BREAKING NEWS – Major Medical Centers Enter into Installation Agreements for Evaluation of BioSig PURE EP™ Systems – New 90-day evaluation cycles enable hospitals to more rapidly assess the platform technology while also accelerating BioSig’s commercial activities – 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, announced this week that it has entered into three new evaluation agreements for the PURE EP™ System, its novel electrophysiology (EP) signal acquisition and analysis technology.
New installations of the PURE EP™ System will now follow a shorter assessment cycle of 90 days based on favorable data from installation evaluations in 2020. As part of its evaluation agreements, the Company’s clinical team provides on-site training and assists with data collection and interpretation, and workflow customization to optimize the user experience for every physician and EP lab staff member.
“Since initiating our first clinical study in November 2019, our team has acquired a wealth of knowledge about the capabilities of the PURE EP™ System in a broad range of clinical cases,” commented Kenneth L. Londoner, Chairman, and CEO of BioSig Technologies, Inc. “Our experience in 2020 has provided the Company meaningful strategic information that gives us confidence in accelerating our rollout and reducing the clinical evaluation period to 90 days or less, beginning with these three major hospitals. With the recent decline of COVID-19 cases reported and the resulting decline in hospitalization rates in the past several weeks, our Company is poised to expand near-term activity on our targeted commercial plans for 2021.”
New clinical sites due to receive BioSig’s PURE EP™ System include New York-Presbyterian/Weill Cornell Medical Center, Michigan Medicine–University Hospital (two centers that account for two of the largest EP programs in the country), and Houston Methodist Hospital. More than 500 patient cases have been conducted using the PURE EP™ System by 34 physicians in seven clinical sites to date.. Read this full press release for BSGM by visiting: https://www.financialnewsmedia.com/news-bsgm/
In other medical device news of note:
Medtronic plc (NYSE: MDT), the global leader in medical technology, recently announced it has received U.S. Food and Drug Administration (FDA) approval of the DiamondTemp™ Ablation (DTA) system which treats patients with recurrent, symptomatic paroxysmal atrial fibrillation (AF) and who have been unresponsive to drug therapy. The DiamondTemp system is the first FDA-approved, temperature-controlled, irrigated radiofrequency (RF) ablation system with diamonds currently available to deliver ablations.
Atrial fibrillation is the most common heart rhythm disorder affecting nearly six million people in the U.S. and more than 37 million people worldwide. The disease involves irregular quivering or rapid heart rhythms in the upper chambers (atria) of the heart. AF ablation is a safe and effective treatment to reduce symptoms and improve quality of life.
Boston Scientific Corporation (NYSE: BSX) generated net sales of $2.708 billion during the fourth quarter of 2020. This represents a decline of (6.8) percent on a reported basis, (8.3) percent on an operational basis and (8.0) percent on an organic basis, all compared to the prior year period. Included within organic results is a negative 370 basis point impact associated with the conversion of U.S. WATCHMAN™ customers to a consignment inventory model and transition to the next-generation WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC) Device. The company reported GAAP net income available to common stockholders of $138 million or $0.10 per share (EPS), compared to GAAP net income of $3.996 billion or $2.83 per share a year ago and achieved adjusted EPS of $0.23 for the period, compared to $0.46 a year ago. In the fourth quarter of 2019, reported GAAP net income included a net income tax benefit of $4.102 billion or $2.90 per share related to an intra-entity asset transfer of intellectual property.
For the full year 2020, the company generated net sales of $9.913 billion. This represents a decline of (7.7) percent on a reported basis, (7.8) percent on an operational1 basis and (11.3) percent on an organic2 basis, all compared to the prior year period. Included within organic results is a negative 170 basis point impact associated with the WATCHMAN™ conversion. The company reported a GAAP net loss available to common stockholders of $(173) million or $(0.12) per share, compared to GAAP net income of $4.700 billion or $3.33 per share a year ago, and delivered full year adjusted EPS of $0.96, compared to $1.58 a year ago. Full year 2019 GAAP EPS included a net income tax benefit of $2.91 per share related to the intra-entity asset transfer of intellectual property discussed above.
TransEnterix, Inc. (NYSE American: TRXC), a medical device company that is digitizing the interface between the surgeon and the patient to improve minimally invasive surgery, recently announced the Company received CE Mark approval for the Intelligent Surgical UnitTM (ISUTM) that enables machine vision capabilities on the SenhanceⓇ Surgical System. This approval will provide Senhance digital laparoscopic programs in Europe access to this new technology, ushering them to the forefront of surgical innovation utilizing augmented intelligence.
“Augmented intelligence powered by machine vision will be one of the primary drivers in transforming surgery to enhance the capabilities of surgeons,” said Anthony Fernando, TransEnterix president and CEO. “We have already successfully implemented augmented intelligence in the U.S. with the Senhance System after receiving FDA clearance last year. We are pleased to expand this important capability to our broader global user base.”
PAVmed Inc. (NASDAQ: PAVM), a highly differentiated, multi-product, commercial-stage medical device company, recently announced that the Company will host a business update conference call on Monday, February 22, 2021 at 4:30 p.m. Eastern time. During the call, Lishan Aklog, M.D., Chairman and Chief Executive Officer of the Company, will provide a business update including an overview of the Company’s near-term milestones and growth strategy. In addition, Dennis McGrath, the Company’s President and Chief Financial Officer, will discuss fourth quarter 2020 financial results.
To access the conference call, U.S.-based listeners should dial (877) 407-3982 and international listeners should dial (201) 493-6780. All listeners should provide the operator with the conference call name “PAVmed, Inc. Business Update Conference Call” to join. Individuals interested in listening to the live conference call via webcast may do so by visiting the investor relations section of the Company’s website at www.pavmed.com.
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