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AI Solutions Continue to Catch FDA & #039;s Eye
FDA has given a nod to yet another artificial intelligence (AI)-based technology. This time the agency has granted a De Novo request to market IDx’s AI-based diagnostic system for the autonomous detection of diabetic retinopathy, which can lead to blindness.
The Coralville IA-based company’s IDx-DR diagnostic received expedited review under the FDA's Breakthrough Devices program.
Earlier this year, the company told MD+DI that it met its endpoints in a pivotal trial of the IDx-DR system. The trial involved 900 diabetes patients at 10 sites. The study was designed to evaluate the diagnostic accuracy of the technology in ...
Source: MDDI - April 12, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Digital Health Source Type: news
Marketing and Opioid Scripts; CBT and Migraine; Cancer Diagnosis and Stroke
(MedPage Today) -- News and commentary from the world of neurology and neuroscience
Source: MedPage Today Psychiatry - May 15, 2018 Category: Psychiatry Source Type: news
Bionik Laboratories Announces Rental Agreement with Tallahassee Memorial HealthCare for InMotion Arm Robotic System
Company's rental program limits upfront expenditures for hospitals and provides them with greater financial flexibility and maximum ROI
TORONTO and BOSTON, May 16, 2018 -- (Healthcare Sales & Marketing Network) -- Bionik Laboratories Corp. (OTCQB: BNKL... Devices Bionik Laboratories, stroke, InMotion Arm Therapy
Source: HSMN NewsFeed - May 16, 2018 Category: Pharmaceuticals Source Type: news
CERENOVUS Receives FDA Clearance For Next Generation Stent Retriever Device Used To Treat Ischemic Stroke
EMBOTRAP II Revascularization Device Captures and Removes Life-threatening Blood Clots, Rapidly Restores Blood Flow
IRVINE, Calif., May 21, 2018 -- (Healthcare Sales & Marketing Network) -- CERENOVUS, part of the Johnson & Johnson Medical Devices Compa... Devices, Interventional, Radiology, Neurology, FDA CERENOVUS, Johnson & Johnson, EMBOTRAP, Revascularization, thrombectomy
Source: HSMN NewsFeed - May 21, 2018 Category: Pharmaceuticals Source Type: news
Effect of Energy Drink Consumption on Power and Velocity of Selected Sport Performance Activities
Jacobson, BH, Hester, GM, Palmer, TB, Williams, K, Pope, ZK, Sellers, JH, Conchola, EC, Woolsey, C, and Estrada, C. Effect of energy drink consumption on power and velocity of selected sport performance activities. J Strength Cond Res 32(6): 1613–1618, 2018—Energy drinks (ED) comprise a multibillion dollar market focused on younger, active, and competitive individuals. Marketing includes claims of improved alertness and performance. The purpose of this study was to assess power (W) and velocity (m·s−1) of a simulated, isolated forehand stroke (FHS), and a countermovement vertical jump (CVJ) before and after ingestio...
Source: Journal of Strength and Conditioning Research - May 23, 2018 Category: Sports Medicine Tags: Original Research Source Type: research
ESO Solutions Predicts Key Hospital Trends to Watch in 2018
Austin, Texas – ESO Solutions, the leading data and software company serving emergency medical services, fire departments, and hospitals, today shared the trends it predicts will have the biggest impact on hospitals in 2018: A greater emphasis on evidence-based approaches to acute conditions; healthcare financing changes affecting the way hospitals admit and readmit patients; reshuffling of hospital ownership; and a shift in how patient volume is managed.
“Few areas of healthcare have seen more significant change over the past several years than hospitals,” said Allen Johnson, Vice President of ESO HDE and Analytics....
Source: JEMS Patient Care - January 5, 2018 Category: Emergency Medicine Authors: ESO Solutions Tags: Patient Care Industry News Source Type: news
Bionik Laboratories Appoints Renaud Maloberti as Chief Commercial Officer
Industry veteran brings extensive experience driving revenue growth while enhancing operational efficiencies and market leadership
TORONTO and BOSTON, June 11, 2018 -- (Healthcare Sales & Marketing Network) -- Bionik Laboratories Corp. (OTCQB: BNKL) (&... Devices, Orthopaedic, Personnel Bionik Laboratories, lower extremity rehabilitation, stroke
Source: HSMN NewsFeed - June 11, 2018 Category: Pharmaceuticals Source Type: news
Dynatronics taps ex-NinePoint CEO von Jako as chief exec | Personnel Moves – July 11, 2018
Dynatronics said late last month it tapped former NinePoint Medical CEO Christopher von Jako as its new chief executive officer and board member, succeeding Kelvyn Cullimore Jr. who will stay on the company’s board of directors.
Prior to joining Dynatronics, von Jako acted as prez & CEO of NinePoint Medical. Before joining Nine Point, von Jako also served as prez & CEO of NeuroTherm, prez of ActiViews and held positions with medtech companies including Integra LifeSciences, Covidien and Medtronic.
“After thorough succession planning and a comprehensive search process, the board is pleased to have foun...
Source: Mass Device - July 11, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News AngioDynamics berkshiresterilemanufacturing Corindus Vascular Robotics Dynatronics Corp Guerbet integer MedPlast Medtronic Myomo Inc NinePoint Medical Inc. Pavmed viant Source Type: news
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
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
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
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
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
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
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
