Friday, January 27th, 2012
Over the years, a growing number of medical device companies in the United States have decided to obtain the CE mark for new products before attempting to approve products through FDA. While FDA is not monolithic, many in the industry view the European system as generally more consistent, transparent, and ...
Posted in Regulation, medtechinsider | 3 Comments »
Monday, November 28th, 2011
Last week, UBM Canon Director of Content Richard Nass blogged about his conversation with eZassi CEO Peter von Dyck. The conversation focused on how US venture capitalists are increasingly endorsing launching medtech products in Europe before launching in the United States. The reason is that European companies usually require less ...
Posted in Industry News, medtechinsider | Add Comment »
Monday, July 25th, 2011
Tension between US FDA and the medical device industry is rising, noted an article on IVD Technology last week. The article focused on a report published last week by US FDA's Center for Devices and Radiological Health. The report places most of the blame for the increased review time for ...
Posted in Regulation | Add Comment »
Tuesday, February 15th, 2011
Is US FDA’s 510(k) process hazardous to your health? Yes, says a five-year study published in the Archives of Internal Medicine, which reports that more than 70% of recalled devices were cleared for market under the protocol. Nonsense, replies US industry association AdvaMed, which points the finger at a deeply ...
Posted in US Regulatory | 2 Comments »
Thursday, April 22nd, 2010
Kimball Electronics Group Inc., a subsidiary of Kimball International Inc. has announced that the company's production facility near Poznan, Poland has achieved the necessary requirements for US FDA registration and ISO 13485 certification. Both the quality certification and US FDA registration help broaden the Poland facility's package of value to ...
Posted in Business News, medtechinsider | Add Comment »
Tuesday, April 20th, 2010
The US Food and Drug Administration (FDA) launched the Center for Devices and Radiological Health (CDRH) Transparency website on 19 April as part of the agency's transparency initiative. The site will provide information about medical device and radiation-emitting product regulatory processes and decisions and summaries of data that provide the ...
Posted in From the Wire, US Regulatory | Add Comment »
Thursday, December 31st, 2009
From the Wire: Cardiac pacemakers, stents and other medical devices implanted each year in hundreds of thousands of patients in the United States often are approved by government regulators based on insufficient scientific review, say researchers from the University of California at San Francisco. The US FDA often approves medical ...
Posted in From the Wire, US Regulatory | 1 Comment »
Wednesday, December 30th, 2009
From the Wire: The Esteem hearing aid, an implantable system based on pacemaker technology, recently has received approval from a panel of ear, nose and throat specialists advising the Food and Drug Administration (FDA). The device, which will carry a price tag of around US$30,000, is implanted in users in ...
Posted in Breaking News, From the Wire | Add Comment »
Monday, November 23rd, 2009
From the Wire: Developed jointly by ANSI, AAMI, ASTM International and DIN, Medical Device Standards Portal provides single source for critical documents from AAMI, ASTM DIN, US FDA, IEC and ISO, including applicable European regulations. The documents are available indexed and in .pdf format. Users can add comments into standards, ...
Posted in Standards | Add Comment »
Monday, March 16th, 2009
Last week, US FDA announced a nanotechnology initiative in collaboration with eight Texas academic institutions that form the Alliance for Nanohealth (ANH; Houston). The goal of the initiative is to "help speed development of safe and effective medical products in the emerging field of nanotechnology" and to find ways to ...
Posted in Nanotechnology and Microtechnology, medtechinsider | Add Comment »
Wednesday, October 29th, 2008
Making good on a commitment to expand its staff presence in foreign countries, US FDA has announced plans to place more than 60 food and drug regulators worldwide over the next year. The first overseas office will be opened in Beijing before the end of the year, according to US ...
Posted in US Regulatory, medtechinsider | Add Comment »
Tuesday, September 16th, 2008
About a million people have to undergo chemotherapy every year and as many as 70% develop nausea as a result of the therapy. If the problem occurs at the hospital, it can be dealt with immediately. But many patients suffer from nausea after being sent home. Anti-nausea pills are available, ...
Posted in US Regulatory | Add Comment »
