FDA rule clears medical devices without human testing - OCRegister
FDA rule clears medical devices without human testing OCRegister The alarming outcomes brought new fuel to a longstanding debate over an FDA rule, known as 510 (k), that allows manufacturers to fast-track new medical devices to market without human testing. The 1976 law was intended to provide quick approval of low- ... |
Pennsylvania firm pioneers rapid medical tests - Philadelphia Inquirer
Pennsylvania firm pioneers rapid medical tests Philadelphia Inquirer By the late 1990s, much of its business involved laboratory substance-abuse tests. An Oregon company, Epitope, had developed a device that could collect and transport oral fluid specimens without the hazards of needles and blood. |
FDA rule clears medical devices without human testing - OCRegister
FDA rule clears medical devices without human testing OCRegister Laurie Kelly of Irvine, diagnosed with breast cancer, went in for a new kind of intra-operative radiation treatment at Hoag Hospital in Newport Beach in June 2010. However, tungsten from the shield used to protect her healthy tissue shed into her body, ... |
Industry Perspective on Reusable Medical Device Cleaning and Validation ... - MarketWatch (press release)
Industry Perspective on Reusable Medical Device Cleaning and Validation ... MarketWatch (press release) AGAWAM, Mass., April 30, 2012 /PRNewswire via COMTEX/ -- A new management brief discusses the potential impact on reusable medical device cleaning validations and testing requirements resulting from the US Food & Drug Administration's (FDA) draft ... |
Sony Makes Sizable Investments in Medical Devices and Clinical Pathology ... - DARKDaily.com - Laboratory News
 DARKDaily.com - Laboratory News | Sony Makes Sizable Investments in Medical Devices and Clinical Pathology ... DARKDaily.com - Laboratory News Sony is laying groundwork for a major expansion into the world of medical devices, with a particular interest in medical laboratory testing and diagnostic test kits. Experts point to Sony's new strategy as a sign that prospects in diagnostic testing ... |
Flexpoint Receives Purchase Order for Medical Device Used in Procedure ... - MarketWatch (press release)
Flexpoint Receives Purchase Order for Medical Device Used in Procedure ... MarketWatch (press release) Prior work on this technology has gone well and the client is anxious to move the development, testing and approval process along as quickly as possible. Since it is a medical application, it will have to go through a rigorous testing process before ... |
Radioactive firefighter illustrates the merits of a medical home - MedCity News
Radioactive firefighter illustrates the merits of a medical home MedCity News Yes, in this case, the driver could rightly say he had done nothing wrong. A sensitive device in the patrol car detected radiation as the motorist drove past. It turns out that the firefighter had undergone a nuclear stress test earlier that day. |
Consumer Reports investigation warns of dangerous medical devices - WGCL Atlanta
Consumer Reports investigation warns of dangerous medical devices WGCL Atlanta By Kara Pesavento - email You may think if a doctor prescribes a medical treatment, it's been thoroughly tested. But for at least one type of treatment, you'd be dead wrong. Dr. Stephen Tower is an orthopedic surgeon. When the arthritis in his hip ... |
Arkema Now Demanding 12-Month Advance Notice on Product Spec Changes to Help ... - HealthTechZone
Arkema Now Demanding 12-Month Advance Notice on Product Spec Changes to Help ... HealthTechZone The diversified chemical producer said that it has put in place a 12-month advance notice for polymers in order to provide medical device manufacturers with the time they need to go through regulatory appraisal. In the past, notifications of change for ... |
Aras as Global PLM Platform for Spontech Spine Intelligence - Today's Medical Developments
Aras as Global PLM Platform for Spontech Spine Intelligence Today's Medical Developments Aras officials announce that Spontech Spine Intelligence AG, a Class 3 medical device company specializing in spine surgery and located Stuttgart, Germany, has selected Aras as its global PLM platform. Spontech will implement Aras solutions for Quality ... |
Why Medical Device Manufactures Should Attend MD&M East
The Medical Device and Manufacturing East Trade Show is being held this year in Philadelphia, PA on May 22-24th at the Philadelphia Convention Center. This show is the medical device industry's trusted resource for education, vendor-supplier partnerships and new technology. If your company manufactures medical devices and you specifically, recommend, or purchase components or production ... Read more
Industry Perspective on Reusable Medical Device Cleaning and Validation Requirements Outlined in New Management Brief
AGAWAM, Mass., April 30, 2012 /PRNewswire/ -- A new management brief discusses the potential impact on reusable medical device cleaning validations and testing requirements resulting from the US Food & ... Read more
FDA rule clears medical devices without human testing
Laurie Kelly blinked awake from surgery at Hoag Hospital in Newport Beach, grateful for the cutting-edge technology that gave her the chance to beat breast cancer in a single day. That June 2010 morning, Hoag doctors removed a tumor from her left... Read more
Staffing and Performance Benchmarks for Quality Function Highlight New Medical Device Study
CHAPEL HILL, N.C., May 4, 2012 /PRNewswire/ -- Medical device and medical technology companies devote significant resources to ensuring that their products meet quality standards and regulations at every ... Read more
Flexpoint Receives Purchase Order for Medical Device Used in Procedure Performed Millions of Times Annually
DRAPER, Utah, May 14, 2012 /PRNewswire/ -- Flexpoint Sensor Systems, Inc. (FLXT.OB) http://www.flexpoint.com , a leader in design and supply of thin film sensing technology, announced today that they ... Read more
NeuroMetrix Announces WellMed Medical Management’s Integration of NC-stat® DPNCheck™ Into Their Patient Evaluation ...
NeuroMetrix, Inc. , www.neurometrix.com, a medical device company focused on the diagnosis and treatment of the neurological complications of diabetes, reported today that WellMed Medical Management, a San Antonio, Texas-based diversified healthcare company and healthcare provider, is integrating the NC-stat DPNCheck into their patient evaluation program. Read more
Questionable medical bill passes through House committee
A bill moving though the House is raising some concern because it allows less testing for medical device companies. Read more
BiO2 Medical Granted CE Mark for the Angel™ Catheter, the First IVC Filter with a Prophylactic Use Indication
SAN ANTONIO, May 15, 2012 /PRNewswire/ -- BiO2 Medical, Inc. a Texas based medical device manufacturer with corporate offices in San Antonio, Texas, and R&D and manufacturing operations in Golden, Colorado, ... Read more
Study Reports Spike In Medical Device Recalls
A new study reveals a spike in medical device recalls, with an increase in excess of 160% in the first quarter of this year alone. This huge increase translates into five times as many medical devices affected in recalls versus … Continue reading → Read more
Capsule Recognizes National Nurses Week and Establishes Nursing Advisory Committee
Capsule Tech, Inc., the leading provider of medical device connectivity, today announced that in honor of National Nurses Week it has organized the Capsule Clinical Committee, a nursing advisory committee made up of Capsule’s team of nurses and a partner network of nursing professionals to help the company develop solutions and services that improve clinical workflows while positively impacting ... Read more
