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ReWalk Robotics raises $4m
ReWalk Robotics (NSDQ:RWLK) has raised approximately $4.3 million in a new round of financing, according to recently posted SEC filings.
In the offering, ReWalk Robotics sold warrants to purchase ordinary shares at a purchase price of approximately $5.20, according to the filing. Warrants offered in the round have an exercise price of $5.14 and are exercisable for 5.5 years from the date of issuance. Warrants were issued on April 5, ReWalk Robotics said.
Money in the round came from three unnamed investors, with the first date of sale noted as having occurred on April 3.
The company is looking to raise an additional appro...
Source: Mass Device - April 9, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Robotics Wall Street Beat ReWalk Robotics Source Type: news
FDA Eyes Tailored Approach to Regulating AI-Based Medical Devices
FDA Commissioner Scott Gottlieb is making the most of his final week at the agency.
In the month that has passed since Gottlieb rattled the medical device industry with news of his impending resignation, the commissioner has issued 18 public statements pertaining to nearly all corners of the agency's realm, from food, tobacco, and cosmetics to drugs and devices. Friday is Gottlieb's last day on the job.
On Tuesday, Gottlieb said the agency will consider a new regulatory framework for reviewing medical devices that use advanced artificial intelligence algorithms. AI has been making headlines in medtech for a whi...
Source: MDDI - April 3, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Software Source Type: news
Cardiovascular Disease in Gout and the Protective Effect of Treatments Including Urate-Lowering Therapy
AbstractCardiovascular disease affects more than 90 million Americans. Recent studies support an increased cardiovascular disease risk in inflammatory conditions, such as gout. Increased serum urate levels, or hyperuricemia, are a precursor to gout. Data from meta-analyses have shown hyperuricemia to be linked to hypertension and coronary heart disease. Similarly, gout has been associated with an increased risk of myocardial infarction, cerebrovascular accidents, and death from cardiovascular disease in randomized clinical trials. Urate-lowering therapy reduces serum urate and may decrease systemic inflammation, generation...
Source: Drugs - March 12, 2019 Category: Drugs & Pharmacology Source Type: research
Water Pipe (Hookah) Smoking and Cardiovascular Disease Risk: A Scientific Statement From the American Heart Association.
The objectives of this statement are to describe the design and operation of water pipes and their use patterns, to identify harmful and potentially harmful constituents in water pipe smoke, to document the cardiovascular risks of water pipe use, to review current approaches to water pipe smoking cessation, and to offer guidance to healthcare providers for the identification and treatment of individuals who smoke tobacco using water pipes.
PMID: 30845826 [PubMed - as supplied by publisher]
Source: Circulation - March 7, 2019 Category: Cardiology Authors: Bhatnagar A, Maziak W, Eissenberg T, Ward KD, Thurston G, King BA, Sutfin EL, Cobb CO, Griffiths M, Goldstein LB, Rezk-Hanna M, American Heart Association Behavioral Change for Improving Health Factors Committee of the Council on Lifestyle and Cardiometab Tags: Circulation Source Type: research
Zynex names new Vice President of Sales and Marketing
ENGLEWOOD, Colo., Feb. 28, 2019 -- (Healthcare Sales & Marketing Network) -- Zynex, Inc. (NASDAQ: ZYXI), an innovative medical technology company specializing in the manufacture and sale of non-invasive medical devices for pain management, stroke rehabili... Devices, Neurology, Personnel Zynex, electrotherapy
Source: HSMN NewsFeed - February 28, 2019 Category: Pharmaceuticals Source Type: news
FDA goes after California stem cell doc for unapproved breast implant device
The FDA this week sent a warning letter to a Beverly Hills, Calif.-based surgeon for their marketing of an unapproved implantable device, dubbed the Pocket Protector, which the surgeon claims can prevent and treat capsular contracture, or scar tissue tightening, during breast implant procedures.
In its letter, the federal watchdog also accuses the surgeon, Dr. Mark Berman, of “significant deviations from the FDA’s quality system requirements and current good manufacturing practices,” including charges related to the sterility of implantable devices.
“This is not the first time the FDA has notified D...
Source: Mass Device - February 15, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cosmetic/Aesthetic Featured Food & Drug Administration (FDA) Stem Cells Source Type: news
Diet Drinks Linked To Increased Stroke Risk & Heart Attacks
This study, as well as other research on the connection between diet beverages and vascular disease, is observational and cannot show cause and effect. That’s a major limitation, researchers say, as it’s impossible to determine whether the association is due to a specific artificial sweetener, a type of beverage or another hidden health issue.
“Postmenopausal women tend to have higher risk for vascular disease because they are lacking the protective effects of natural hormones,” North Carolina cardiologist Dr. Kevin Campbell said, which could contribute to increased risk for heart disease and stroke...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - February 14, 2019 Category: Consumer Health News Authors: Health – CBS Boston Tags: Health News CNN Heart Attack Stroke Source Type: news
Diet Beverages Linked To Increased Stroke Risk & Heart Attacks
This study, as well as other research on the connection between diet beverages and vascular disease, is observational and cannot show cause and effect. That’s a major limitation, researchers say, as it’s impossible to determine whether the association is due to a specific artificial sweetener, a type of beverage or another hidden health issue.
“Postmenopausal women tend to have higher risk for vascular disease because they are lacking the protective effects of natural hormones,” North Carolina cardiologist Dr. Kevin Campbell said, which could contribute to increased risk for heart disease and stroke...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - February 14, 2019 Category: Consumer Health News Authors: Health – CBS Boston Tags: Health News CNN Heart Attack Stroke Source Type: news
ReWalk Announces Cigna as First Private U.S. Insurer to Adopt National Policy Change for Coverage of Personal Exoskeleton Devices
Cigna Transitions to Case-by-Case Review Process, Eliminating Non-Coverage Policy
MARLBOROUGH, Mass. and YOKNEAM ILIT, Israel, Feb. 13, 2019 -- (Healthcare Sales & Marketing Network) -- ReWalk Robotics, Ltd. (Nasdaq: RWLK) ("ReWalk" or the &q... Devices, Reimbursement ReWalk Robotics, stroke
Source: HSMN NewsFeed - February 13, 2019 Category: Pharmaceuticals Source Type: news
Past Covidien, ev3 Activities are Costing Medtronic a Hefty Sum
Sometimes acquiring other companies means taking the bad with the good. In Medtronic's case, that means settling multiple Department of Justice claims against ev3, a business Medtronic owns by way of its Covidien acquisition.
Covidien bought ev3 in 2010 and Medtronic finalized its $49.9 billion Covidien deal in early 2015. Now, Medtronic is paying the price for activities that ev3 allegedly conducted between 2005 and 2009 involving the Onyx Liquid Embolic System.
FDA approved the device in 2005 as a liquid embolization device that is surgically injected into blood vessels to block blood flow to arteriovenous malformations ...
Source: MDDI - December 5, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news
Medtronic to pay $51m to settle Covidien, ev3 DoJ investigations
Medtronic (NYSE:MDT) said yesterday that it agreed to pay $50.9 million to settle a number of U.S. Dept. of Justice probes into marketing activities from companies it acquired, Covidien and ev3.
Medtronic said that its subsidiary ev3, acquired when the Fridley, Minn.-based medtech giant picked up Covidien in 2015, agreed to plead guilty to a misdemeanor charge related to its marketing of the Onyx Liquid Embolic System, pay $17.9 million and adopt new compliance and reporting terms for three years.
The charges relate to ev3’s marketing of the device for “unproven and potentially dangerous uses,” federal prose...
Source: Mass Device - December 5, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured Legal News Medtronic Source Type: news
Umbilical Cord Blood Mononuclear Cells for Ex-Vivo Gene Therapy
This study was supported by the grant of Russian Science Foundation No 16-15-00010. Kazan Federal University was supported by the Russian Government Program of Competitive Growth.DisclosuresNo relevant conflicts of interest to declare.
Source: Blood - November 21, 2018 Category: Hematology Authors: Bashirov, F. V., Salafutdinov, I. I., Sokolov, M. E., Izmailov, A. A., Markosyan, V. A., Fadeev, F. O., Rizvanov, A., Islamov, R. I. Tags: 801. Gene Therapy and Transfer Source Type: research
Tobacco Product Use Among Adults - United States, 2017.
Abstract
Cigarette smoking harms nearly every organ of the body and causes adverse health consequences, including heart disease, stroke, and multiple types of cancer (1). Although cigarette smoking among U.S. adults has declined considerably, tobacco products have evolved in recent years to include various combustible, noncombustible, and electronic products (1,2). To assess recent national estimates of tobacco product use among U.S. adults aged ≥18 years, CDC, the Food and Drug Administration (FDA), and the National Institutes of Health's National Cancer Institute analyzed data from the 2017 National Health Int...
Source: MMWR Morb Mortal Wkl... - November 9, 2018 Category: Epidemiology Authors: Wang TW, Asman K, Gentzke AS, Cullen KA, Holder-Hayes E, Reyes-Guzman C, Jamal A, Neff L, King BA Tags: MMWR Morb Mortal Wkly Rep Source Type: research
FDA approves Abbott ’ s HeartMate 3 as a destination therapy
Abbott (NYSE:ABT) said today it won FDA approval for its HeartMate 3 left ventricular assist device, now approved as a destination therapy for patients with advanced heart failure.
With the approval, the Chicago-based company said that the device can now be used in patients not eligible for a transplant as a life-long implant.
“We partner with physicians to holistically develop therapies that benefit patients and achieve better outcomes. The unique design of the HeartMate 3 LVAD—with its Full MagLev technology—takes an established innovation and improves upon it in meaningful ways to help people with advanced he...
Source: Mass Device - October 19, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Abbott Source Type: news
Hookah smoking raises cardiovascular risk comparable to traditional cigarette smoking, study finds
This study is believed to be the first to investigate the effects of hookah smoking on stiffening of the arteries. Studies have shown that as cigarette use continues to decline, hookah smoking is rising, especially among youth and particularly among college students.“We know that flavored tobacco products are frequently the first kind of tobacco product used by youth,” Rezk-Hanna said. “One of the major issues with hookah is the fact that the tobacco is flavored with fruit, candy and alcohol flavors, making hookah the most popular flavored tobacco produc t among this audience.”According to the Food and Drug Admini...
Source: UCLA Newsroom: Health Sciences - August 2, 2018 Category: Universities & Medical Training Source Type: news
