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*  PAREXEL
It conducts clinical trials on behalf of its pharmaceutical clients to expedite the drug approval process. It is the second ... biotechnology and medical device industries based in Massachusetts. March 1998: PAREXEL acquires four companies: PPS Europe ... Sayigh initially to advise Japanese and German firms on how to navigate the FDA approval process. The firm has grown ...
*  Breast Cancer Action
... drug and device approval; and more effective, less costly, and less toxic treatments. Root Causes of Breast Cancer: Over half ... A lawsuit was filed in 2011 challenging California's approval of methyl iodide. Subsequently, the manufacturer withdrew the ...
*  Road speed limit enforcement in the United Kingdom
"Radar speed measuring device approval". "Light beam speed measuring device approval 1993". "Speed enforcement". Brake. " ... These devices do not enforce speed limits as they do not adapt to speed limit changes. Swindon council is planning to install ... The LTI 20.20, a police operated LIDAR speed gun received type approval in 1993. The charity Brake was formed in 1995 to ... Oxfordshire pulled the plug on its network of 72 devices after the ConDems axed funding by 40%. Buckinghamshire is to follow ...
*  Targeted therapy
1] "Therascreen KRAS RGQ PCR Kit - P110030". Device Approvals and Clearances. U.S. Food and Drug Administration. 2012-07-06. ...
*  Cetuximab
"Therascreen KRAS RGQ PCR Kit - P110030". Device Approvals and Clearances. U.S. Food and Drug Administration. 2012-07-06. " ... Cetuximab failed to get FDA approval in 2001, which caused the stock price of the developer ImClone to drop dramatically. Prior ...
*  Diana Zuckerman
Zuckerman DM, Brown P, Nissen SE (June 2011). "Medical device recalls and the FDA approval process". Archives of Internal ... Zuckerman DM, Brown P, Nissen SE (June 2011). "Medical device recalls and the FDA approval process". Archives of Internal ... Redberg RF, Dhruva SS (June 2011). "Medical device recalls: get it right the first time: Comment on "Medical device recalls and ... determined that most of the devices that were high-risk recalls had never been studied in clinical trials prior to FDA approval ...
*  History of invasive and interventional cardiology
"New Device Approval: TAXUS Express2 Paclitaxel-Eluting Coronary Stent System". U. S. Food And Drug Administration. March 4, ... This led to the approval for the stent to be used in Europe in April 2002. Further trials with the Cypher stent revealed that ... This led to the inception and use of a number of procedures and devices in the interventional realm that have fallen out of ... "Circulatory System Devices Panel Advisory Meetings". United States Food And Drug Administration. December 8, 2006. Retrieved ...
*  Cataract surgery
New Device Approval - CrystaLens Model AT-45 Accommodating IOL - P030002. U.S. Food and Drug Administration. "Intraocular ... It can be safely and painlessly corrected using a laser device to make small holes in the posterior lens capsule of the ... approval for this type of product was issued. The development of intraocular lenses brought about an innovation as patients ... or a proprietary insertion device provided along with the IOL. The lens implanted is inserted through the incision into the ...
*  Mynx vascular closure device
The Mynx received FDA Premarket Approval (PMA) in May, 2007. The device uses a soft, sponge-like sealant material to close the ... The device is manufactured by AccessClosure, Inc., a medical device company located in Mountain View, California. ... The Mynx Vascular Closure Device is an extravascular vascular closure device (VCD) whose deployment system is designed to ... The device utilizes a gentle, extravascular deployment method, which avoids cinching or tugging of the artery by placing the ...
*  Drug-eluting stent
"New Device Approval - P030025 - TAXUS Express2 Paclitaxel-Eluting Coronary Stent System". Archived from the original on 2008-02 ... After a larger pivotal trial (one designed for the purpose of achieving FDA approval), published in 2003, the device received ... These devices have significantly reduced the need for a second surgery to treat restenosis for thousands of patients each year ... Soon thereafter, a series of trials of paclitaxel-eluting stents led to FDA approval of the Taxus stent in 2004. The first ...
*  Mound system
Special Device Approval per OAC 3701-29-20(C). Ohio Department of Health. Accessed on Dec 3, 2007 Link Archived 2008-12-31 at ...
*  21st Century Cures Act
Proponents said that it would streamline the drug and device approval process and bring treatments to market faster. Opponents ... The expedited drug approval process has been one topic of concern and debate The Public Citizen's Health Research Group and the ... process by which new drugs and devices are approved by easing the requirements put on drug companies looking for FDA approval ... She said the legislation watered down safety requirements for new drugs and devices and then, as a trade-off, called for ...
*  Cardiac contractility modulation
Further clinical research are under way to identify which patient group within the scope of the device approval benefits most ... Announcement of the launch of the OPTIMIZER IVs CCM device on Implantable-Device.com CCM device application draft Patent for ... Cardiac contractility modulation devices are similar in structure to other implantable devices used for electrical stimulation ... Until recently, the only other available device-based treatment was the left ventricular assist device (LVAD). LVAD therapy is ...
*  Medical imaging
Device Approvals and Clearances, - [1]. Retrieved 2012-31-08 "FDA: Statistical Guidance for Clinical Trials of Non Diagnostic ... In most scenarios, a frame grabber is used in order to capture the video signal from the medical device and relay it to a ... This essentially means that the human is now the source of the radioactivity, rather than the medical imaging devices such as X ... Tactile imaging closely mimics manual palpation, since the probe of the device with a pressure sensor array mounted on its face ...
*  Alternating electric field therapy
... the device manufacturer was required to conduct additional clinical trials as a condition of device approval. Critics suggested ... When not in use, the devices are plugged into a power outlet to be re-charged. The NovoTTF-100A / Optune device was approved by ... These devices generate electromagnetic waves between 100 and 300 kHz. The devices can be used in conjunction with regular ... A clinical TTF device is manufactured by Novocure under the trade name Optune (formerly NovoTTF-100A), and is approved in the ...
*  Neuroelectrics
Other accreditations include Health Canada Medical Device License Approval for both Starstim and Enobio. Starstim complies with ... Both Starstim and Enobio are CE certified medical devices targeted to the medical and research communities. The US Federal law ... Neuroelectrics is a Barcelona-based Spanish company which produces devices to stimulate and treat the brain. Founded in 2011, ... Enobio is a wireless and wearable brain monitoring device that record electroencephalogram (EEG). Starstim is a hybrid brain ...
*  Radiofrequency ablation
The device obtained FDA approval in 2012. The device is inserted via a laparoscopic probe and guided inside the fibroid tissue ... King, Paula (10 December 2012). "Brentwood medical company obtains FDA approval for new medical device". The Mercury News, ... Unlike other electrosurgical devices, RFA allows very specific treatment targeting of the desired tissue with a precise line of ... If any Barrett's esophagus is found, the disease can be treated with a focal RFA device. Between 80-90% or greater of patients ...
*  Federal Food, Drug, and Cosmetic Act
... the device nominally must go through a premarket approval, or PMA. This does not always happen. A device that reaches market ... Devices that do not meet either criterion are generally cleared as class II devices. For devices that were marketed prior to ... Devices that do not require premarket approval or clearance but must follow general controls. Dental floss is a class I device ... the maker of the medical device must submit an application to the FDA and must receive approval prior to marketing the device. ...
*  List of MeSH codes (G03)
... device approval MeSH G03.850.295.300 --- fomites MeSH G03.850.310.300 --- disease transmission, horizontal MeSH G03.850.310.300 ...
*  California Healthcare Institute
... on FDA medical device regulation. The report defended the expedited approval process for devices and said that "Devices, in ... which concluded that device approval times had increased, that approval times in the European Union were faster than those in ... 2011 Dems slam FDA critics ahead of medical device hearing By Julian Pecquet, The Hill, 20 July 2011. [1] House of ... and medical device companies. Founded in 1993, and based in La Jolla, California, CHI has offices in Washington, D.C., and ...
*  Percutaneous aortic valve replacement
This device received FDA approval in January 2014. Boston Scientific's Lotus Valve system was awarded CE approval in October ... The devices are implanted without open heart surgery. The valve delivery system is inserted in the body, the valve is ... In the US, it received FDA approval in November 2011 for use in inoperable patients and in October 2012 for use in patients at ... Afterwards, the hole in the aorta is closed with a self-collapsing nitinol device designed to close holes in the heart. ...
*  Renal sympathetic denervation
Currently, no renal denervation device has FDA approval. The procedure involves endovascular access via the femoral artery with ... The device uses radiofrequency or ultrasound to ablate the renal nerves. Typically, numerous ablations are applied at a ... Several commercial devices exist. These include Medtronic's Symplicity Renal Denervation System, St. Jude Medical's EnligHTN™ ... advancement of a catheter-mounted device into the renal artery. ...
*  Medical research
Contributing factors to this growth are thought to be less rigorous FDA approval requirements for devices as opposed to drugs, ... and in some areas a marked decline in the number of drug and device approvals over the same time period. Today, industry ... It is generally supervised by doctors in a medical setting such as a hospital and requires ethical approval. Research funding ... Typically the work requires no ethical approval (though work with animals does), is supervised by scientists rather than ...
*  Erie County Sheriff's Office (New York)
Most often it has used the device without court approval. New York portal Law enforcement/Law enforcement topics portal List of ...
*  National Health Insurance (British Virgin Islands)
Casualty and emergency care Pharmaceutical services Mental health Dental care Vision care Approved prosthetic devices Approval ... 1,500 per year and require Medical Review Committee pre-approval General diagnostic testing is capped at US$500 per year No ... 20,000 No emergency overseas treatment without Medical Review Committee approval Maximum lifetime benefits limit of US$ ...
*  Driver's licence in Canada
Hearing device required Condition E: Visual device required Condition F: Driver training conditions Condition G: Restricted ... Class 4 - taxis (must also have a Certificate of Approval and a Certificate of Good Moral Character), ambulances and buses ... Hearing device required when operating Class A or D vehicle in United States Condition R: Class A vehicle restriction (cannot ...
*  Product recall
Medical Device Recalls and the FDA Approval ProcessMedical Device Recalls and FDA Approval Process". Archinte.ama-assn.org. ... February - Study on Medical device recall by Dr. Diana Zuckerman and Paul Brown of the National Research Center for Women and ... October 11, 2016 Samsung stopped production of the problematic Galaxy Note 7 devices for nine months and have recalled the ... Steven Nissen of the Cleveland Clinic, published in the Archives of Internal Medicine, showed that most medical devices ...