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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 ...
*  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. ...
*  Sensei robotic catheter system
Hansen Medical received unconditional Investigational Device Exemption (IDE) approval from the FDA initiating a clinical trial ... Meanwhile, it has CE mark approval for facilitating the navigation of ablation catheters within the atria of the heart during ...
*  Transdermal
Some have regulatory approval. Microneedle devices/patches can be used to deliver nanoparticle medicines. Devices and ... Verma, D.D. & Fahr, A. "Investigation on the efficacy of a new device for substance deposition into deeper layers of the skin: ... A third pathway to breach the Stratum Corneum layer is via tiny microchannels created by a medical micro-needling device of ...
*  Obstructive sleep apnea
Approval for this active implantable neuromodulation device was preceded by a clinical trial whose results were published in ... This device is a mouthguard similar to those used in sports to protect the teeth. It is designed to hold the lower jaw slightly ... The device includes a handheld patient controller to allow it to be switched on before sleep and is powered by an implantable ... FDA "Premarket Approval (PMA) Inspire II Upper Airway Stimulation System" U.S. Food and Drug Administration. April 30, 2014. ...
*  Extracorporeal shock wave lithotripsy
... lithotripter in the fragmentation of kidney and ureteral calculi has become well-established since approval of the first device ... The patient lies down in the apparatus' bed, with the back supported by a water-filled coupling device placed at the level of ... EDAP LT 01 and Sonolith 2000 devices". J. Urol. 146 (2): 294-7. Thomas R, Macaluso JN, Vandenberg T, Salvatore F (1993). "An ... A demonstration of an extracorporeal shock wave lithotripsy device, March 19, 2010, retrieved January 6, 2017 "Clinical & ...
*  Dalkon Shield
... to require testing and approval of "medical devices", including IUDs.[citation needed] The Dalkon Shield became infamous for ... Modern Intrauterine devices (IUDs) use monofilament strings which do not pose this grave risk to users. Thomas Jr., Robert McG ... Based on an estimate of 3.2 million IUD users, the CDC estimated an annual device-related hospitalization rate of 5 per 1000 ... Lawyers for the plaintiffs argued that the women they represented would be healthy and fertile today if not for the device. ...
*  Public Citizen Litigation Group
... preempts state-law claims seeking damages for injuries caused by medical devices that received premarket approval from the Food ... In 2002, when the National Highway Traffic Safety Administration issued a rule to implement a law that required a device in new ... Riegel v. Medtronic (2008), in which the Court held that the express preemption provision of the Medical Device Amendments to ... v. Lohr (1996), in which the Court rejected the medical device industry's broad claims to immunity from product liability suits ...
*  Blank Slate (The Outer Limits)
... took an interest in his invention but perverted it and began testing his device on homeless people without his approval. He ... Tom destroys the fifth crystal along with the knowledge it contains to replicate his memory device and processes vowing to ...
*  Fisher Wallace Laboratories
June 11, 2014 FDA To Propose Approval/Reclassification of Cranial Electrotherapy Stimulation Devices for Insomnia Melinda Beck ... CES devices to conduct new clinical trials to prove the safety and efficacy of the devices and to submit Premarket Approval ... Fisher-Wallace is a late entry to the CES field; such devices have been marketed since the 1940s, especially in Russia. It has ... In 2016, in response to the FDA's next effort to regulate the device class, the company alleged that there was "evidence of ...
*  Pharmaceutical Product Development
PPD provides product development and post-approval services for biopharmaceuticals and devices, as well as full service Phase ... The company's post-approval services include epidemiology, risk management and outcomes research; late-stage trials; medical ... The company's clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations ... development and post-approval services as well as compound partnering programs. ...
*  Epinephrine autoinjector
... and Teva settled in April 2012 in a deal that allowed Teva to start selling the device in mid-2015, pending FDA approval. In ... The devices contain a fixed dose of epinephrine and a spring-loaded needle that exits the tip or edge of the device and ... July 20, 2005 Spokane firm sells rights to auto-injector FDA Twinject Approval Package FDA Approval History NDA 020800 - ... the angle at which the device is placed on the skin and the force used to activate the device as well as how well the user ...
*  Heat-not-burn tobacco product
... former employees detailing irregularities in the clinical trials conducted by Philip Morris for the approval of the IQOS device ... The IQOS smoking device consists of a charger around the size of a mobile phone and a holder that looks like a pen. The ... Philip Morris states that the IQOS smoking device is as addictive as conventional tobacco smoking. IQOS is sold with a warning ... A 2017 review found "little research on what substances are released after the device heats the tobacco-based paste. The ...
*  Philip Morris International
... former employees detailing irregularities in the clinical trials conducted by Philip Morris for the approval of the IQOS device ...
*  James Doty (physician)
... prior to FDA approval under an Investigational Device Exemption. Within one year of the facility opening, Accuray was ... Doty remains a consultant and advisor to medical technology and device companies and a variety of venture capital firms. He is ... "Device and method for monitoring evoked potentials and electroencephalograms". Retrieved 7 September 2013. Doty, J. R., Mahla, ... Following development of the prototype device at Stanford University, Doty was so convinced of its potential to change the ...
*  Fieldbus Foundation
2011 Registration of first H1 isolated device couplers, Sept. 2012 Approval of wireless backhaul architecture model developed ... Similar to WirelessHART devices, ISA 100.11a devices will be represented as transducer blocks in Foundation ROM devices. In ... the foundation announced that TÜV had granted Protocol Type Approval for its fieldbus specifications. TÜV Type Approval helps ... The HSE remote I/O (HSE RIO) specification allows end users to access high data requirement devices directly in the fieldbus ...
*  History of hearing aids
... the first digital hearing aid application to win CE certification and FDA approval as a medical device. One of the first ... However, these devices were generally bulky and had to be physically supported from below. Later, smaller, hand-held ear ... "Concealed Hearing Devices of the 19th Century". James Wilbur Hall (1998). Audiologists' Desk Reference: Audiologic management, ... "Deafness in Disguise: Concealed Hearing Devices of the 19th and 20th Centuries". Washington University School of Medicine. 15 ...
*  Every Little Hurts
... his approval after viewing it on his tablet computer device. Former Labour minister Pat Rabbitte was referring to "Every Little ...
*  World Usability Day
Whether it's new medical devices or technologies; drug research, approval, or delivery; patient forms or medical record sharing ... Whether it's new medical devices or technologies; drug research, approval or delivery; patient forms or medical record sharing ... The world of entertainment has embraced technology to give us photos, movies, music and games in new ways and on new devices. ...
*  Mind machine
With some exceptions, these devices commonly do not have FDA approval for medical applications in the USA. They have been found ... One company making medical claims for a possibly unsafe device has been shut down and seen their devices destroyed. Hemi-Sync ... Professionally, they are usually referred to as Auditory Visual Stimulation Devices (AVS devices). Also mind machines are ... Unlike flashing light devices, the dreamachine can be used by several people at once, but has few, if any, technical features. ...
*  Medical device manufacturing
Prior to marketing such a device, the rights-holder(s) or person(s) with authorized access must seek FDA approval. The review ... Many Class III devices have established guidelines for Premarket Approval (PMA), however with ongoing technological advances ... Class III devices are those considered the most high-risk. These devices may be used in support or sustenance of human life, ... Medical device manufacturing, as the name suggests, refers to the production of medical devices. Due to the large amount of ...
*  Bioresonance therapy
... as Class III devices, which require FDA approval prior to marketing. The FDA has banned some of these devices from the US ... The devices would need to be able to isolate and pinpoint pathogens' responses from the mixture of responses the device ... In the United States of America the U.S. Food and Drug Administration (FDA) classifies "devices that use resistance ... market, and has prosecuted many sellers of electrical devices for making false claims of health benefits. According to ...
*  The Public Prosecution Service v William Elliott, Robert McKee
This case clarifies that evidence obtained using certain devices at the time lacking approval, even if there is a statutory ... that an approved device must be used and therefore that evidence obtained through the use of an unapproved device rendered the ... for other devices such as traffic speed gun and breathalyser test devices. Under common law practised in the UK, evidence is ... as the device used to record the fingerprints was not an approved device; they were subsequently acquitted. The Public ...
*  Pharmaceutical Affairs Act (Japan)
... the Government Cabinet approved a revision of Pharmaceutical Affairs Law to simplify the approval process for medical devices ... The July 2002 amendment to the law changed the regulatory structure for pharmaceuticals and medical devices, in an effort to ... and sale of drugs and medical devices. It was originally passed in 1960. ...
*  Hybrid cardiac surgery
... that is still dependent on approval of the necessary devices by the U.S. Food and Drug Administration. Some of these devices ... The reason is that the metal devices are optimally imaged without artifacts by fluoroscopy whereas the valve itself is better ...
*  SECU-3
Device performed on the 8-bit AVR microcontroller ATMega644, with 64kB memory (ROM), 4kB random access memory (RAM), and ... developments can not be used in commercial purposes without written approval of author (according to information from the ... Device controls the ignition, fuel injection and various other actuators of the internal combustion engine (ICE) and vehicle. ...
*  Unique Device Identification
... and while the FDA have been given approval to exempt some devices, Jay Crowely (who was responsible for implementing the UDI ... the manufacturer of the device, expiry dates, the make and model of the device, and any special attributes that the device may ... While many device attributes may be updated once the device record is published within the GUDID, several attributes cannot be ... The Unique Device Identification (UDI) System is intended to assign a unique identifier to medical devices within the United ...