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Specialty: Consumer Health News
Management: Food and Drug Administration (FDA)
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Total 1391 results found since Jan 2013.
Protect Medical Devices From Cyber Attacks, FDA Urges
The FDA is urging medical device makers and health care facilities to make sure there are proper safeguards in place to protect their medical devices from cyber threats. The FDA (Food and Drug Administration) said on Thursday that its warning is directed specifically at biomedical engineers, health care IT and procurements staff, medical device user facilities, hospitals and medical device manufacturers. A cyber attack may be caused when *malware is introduced into medical equipment, as well as unauthorized people gaining access to configuration settings in hospital networks and equipment...
Source: Health News from Medical News Today - June 14, 2013 Category: Consumer Health News Tags: Medical Devices / Diagnostics Source Type: news
Mass. Approves First 20 Medical Marijuana Dispensary Licenses
BOSTON (AP) — State public health officials awarded Friday the first 20 licenses to operate medical marijuana dispensaries, the first in Massachusetts under a voter-approved law.
The Department of Public Health reviewed applications from 100 finalists seeking to operate the dispensaries. The law allows for up to 35 dispensaries around the state, and it was not immediately clear when additional licenses would be granted.
Read: List of Approved Applications (.pdf)
The law allows marijuana to be used for certain medical conditions, including cancer, multiple sclerosis and Parkinson’s disease.
WBZ NewsRadio 1030′...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - January 31, 2014 Category: Consumer Health News Authors: miketoole Tags: Health Heard On WBZ NewsRadio 1030 Local Seen On WBZ-TV Watch Listen Carl Stevens CBS Boston Christina Hager dispensaries Karen Twomey Licenses Massachusetts Medical Marijuana Michelle Roberts Source Type: news
U.S. FDA Approval Of Aorfix™
Lombard Medical Technologies PLC (AIM: LMT), the specialist medical technology company focused on innovative vascular products, has announced that Aorfix™ has been approved for commercial sale in the U.S. by the U.S. Food and Drug Administration ("FDA"). Aorfix™ is the Company's flexible stent graft for the endovascular repair of abdominal aortic aneurysms ("AAAs"). Data from the U.S...
Source: Health News from Medical News Today - February 19, 2013 Category: Consumer Health News Tags: Medical Devices / Diagnostics Source Type: news
FDA issues final guidance for mobile medical apps
The US Food and Drug Administration (FDA) announced that it has issued final guidance for developers of medical mobile apps - user-friendly software programs that run on mobile communication devices, such as smartphones and tablet computers. The guidance reveals that the federal agency will focus regulation on a small subset of medical apps that present a greater risk and will exercise discretion for the majority that pose minimal risk to consumers...
Source: Health News from Medical News Today - September 24, 2013 Category: Consumer Health News Tags: Regulatory Affairs / Drug Approvals Source Type: news
Mobile medical apps: FDA issues final guidance
The US Food and Drug Administration (FDA) announced that it has issued final guidance for developers of medical mobile apps - user-friendly software programs that run on mobile communication devices, such as smartphones and tablet computers. The guidance reveals that the federal agency will focus regulation on a small subset of medical apps that present a greater risk and will exercise discretion for the majority that pose minimal risk to consumers...
Source: Health News from Medical News Today - September 24, 2013 Category: Consumer Health News Tags: Regulatory Affairs / Drug Approvals Source Type: news
Draft U.S. Legislation Would Curb FDA Medical Software OversightDraft U.S. Legislation Would Curb FDA Medical Software Oversight
A draft U.S. bill is circulating in Washington D.C. that would curb the U.S. Food and Drug Administration's regulatory oversight over electronic medical records and some clinical support software, according to a copy of the legislation seen by Reuters. Reuters Health Information
Source: Medscape Medical News Headlines - November 25, 2014 Category: Consumer Health News Tags: Family Medicine/Primary Care News Source Type: news
FDA Medical Device Proposal May Skirt the Law FDA Medical Device Proposal May Skirt the Law
A proposal by the U.S. Food and Drug Administration to create a new fast-track path to market for medical devices may exceed its authority and require some creative reasoning to justify, legal experts said.Reuters Health Information
Source: Medscape Medical News Headlines - December 21, 2017 Category: Consumer Health News Tags: Family Medicine/Primary Care News Source Type: news
Bayer Hits Back at New Netflix Medical Device Documentary Bayer Hits Back at New Netflix Medical Device Documentary
Bayer AG disputed accusations in a new Netflix documentary that claims medical device makers and the U.S. Food and Drug Administration placed profits before patient safety.Reuters Health Information
Source: Medscape Medical News Headlines - July 30, 2018 Category: Consumer Health News Tags: Medscape Today News Source Type: news
Medical Devices Very Vulnerable to Hacking, FDA Experts Warn Medical Devices Very Vulnerable to Hacking, FDA Experts Warn
Networked medical devices are increasingly prone to cybersecurity threats, according to a US Food and Drug Administration panel of experts. How to communicate with patients about the problem is important.Medscape Medical News
Source: Medscape Medical News Headlines - September 12, 2019 Category: Consumer Health News Tags: Family Medicine/Primary Care News Source Type: news
F.D.A. Warns St. Jude Medical Over Defibrillators
Federal regulators have asked St. Jude Medical to clear up problems in the manufacturing and quality control of its heart defibrillators.
Source: NYT Health - January 14, 2013 Category: Consumer Health News Authors: By THE ASSOCIATED PRESS Tags: Regulation and Deregulation of Industry St Jude Medical Inc STJ NYSE Food and Drug Administration Accidents and Safety Source Type: news
Shedding Light On Approval Process For Implantable Body Parts: Preventing Unsafe High-Risk Medical Devices From Reaching The Marketplace
Technological advancements in medicine have allowed patients suffering from musculoskeletal conditions such as hip and knee pain to regain mobility and live relatively pain-free. But some "high risk" surgical devices that have been approved by the U.S. Food and Drug Administration (FDA) are not required to go through clinical trials, where a product is tested to determine its safety and effectiveness. "This could be potentially very dangerous...
Source: Health News from Medical News Today - January 24, 2013 Category: Consumer Health News Tags: Medical Devices / Diagnostics Source Type: news
FDA Approves First Medical Robot For Hospital Use
A robot that allows patients to communicate with doctors via a telemedicine system that can move around on its own has just received 510(k) clearance by the FDA (Food and Drug Administration). The robot, called RP-VITA, was created by InTouch Health and iRobot and allows doctors from anywhere in the world to communicate with patients at their hospital bedside via a telemedicine solution through an iPad interface...
Source: Health News from Medical News Today - January 26, 2013 Category: Consumer Health News Tags: Medical Devices / Diagnostics Source Type: news
Medtronic Gains First FDA Approval To Conduct Early Feasibility Medical Device Study
Shared Commitment to Innovation Enables Early Study of Novel Native Outflow Tract Transcatheter Pulmonary Valve in Patients with Pulmonary Valve Failure Medtronic, Inc. (NYSE: MDT) today announced that it has received U.S. Food and Drug Administration (FDA) approval to conduct an early feasibility study using the Medtronic Native Outflow Tract Transcatheter Pulmonary Valve (TPV). This approval represents the first-ever FDA approval of an investigational device exemption (IDE) following the new draft FDA guidance for early feasibility studies...
Source: Health News from Medical News Today - March 1, 2013 Category: Consumer Health News Tags: Medical Devices / Diagnostics Source Type: news
FDA Warns Medical Manufacturers About Using "Latex Free" Labels
The U.S. Food and Drug Administration has just issued a warning to medical device manufacturers stating that they should provide accurate information about their products that don't contain natural rubber latex (NRL) and stop labeling them as "latex free". NRL is natural milk-like substance found in plant sources, after repeated exposure to NRL some people can have severe allergies, and develop hives or rashes. In some cases the reactions can be so bad that the patient experiences wheezing and serious breathing difficulties...
Source: Health News from Medical News Today - March 10, 2013 Category: Consumer Health News Tags: Allergy Source Type: news
More Oversight Of AEDs Proposed By FDA
A proposal to improve the quality and reliability of automated external defibrillators (AEDs) has been issued by the U.S. Food and Drug Administration. Manufacturers of these life-saving devices will need to send in pre-market approval (PMA) applications if the proposed order is finalized. AEDs are medical tools that are portable and electronic. By using electrical stimulation, they are able to automatically re-establish regular heart rhythms when they sense possibly fatal cardiac arrhythmia. Many lives have been saved over the years because of AEDs...
Source: Health News from Medical News Today - March 23, 2013 Category: Consumer Health News Tags: Medical Devices / Diagnostics Source Type: news
