Medtech Week Recap

Monday, August 1st, 2011

The week of July 25 ended with a whimper, as the Institute of Medicine issued its report on the “flawed” 510(k) process. US industry association AdvaMed dismissed the report as undeserving of “serious consideration,” but US FDA has opened a public docket and is inviting comments nonetheless. The DeviceTalk blog ...

Two Out of Three US Medtech Manufacturers Prefer Europe

Wednesday, May 25th, 2011

Two-thirds of small medical device and diagnostic companies are obtaining clearance for new products in Europe first, according to a comprehensive industrywide survey about US FDA's 510(k) product review process by researchers at Northwestern University. According to the poll, which surveyed more than 350 professionals engaged in medical device development ...

Kimball Electronics Poland Operation Achieves Certification to ISO 13485

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 ...

US FDA Launches Medical Device and Radiation-Emitting Product Transparency Website

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 ...

Obama Wants to Boost US FDA Budget

Tuesday, May 12th, 2009

US President Barack Obama wants to give US FDA the largest funding boost in its history. His budget request calls for US$2.35 billion for fiscal year 2010, compared with US$2.06 billion in the previous fiscal year, reports the Wall Street Journal. Food safety oversight is the big winner, increasing from ...

New Computer Model Simulates Drug-Eluting Stent Behaviour In Vivo

Tuesday, January 27th, 2009

[caption id="attachment_3999" align="alignleft" width="350" caption="Taken from MIT’s computer-modeling software, this image shows the arterial drug distribution patterns for three different scenarios of drug release in a single stent. Blood flow in this 3-D simulation is from left to right. Red represents the highest concentration of drug release and blue represents ...

Course at Cranfield University Dedicated to US Regulation of Medical Technology

Friday, January 23rd, 2009

Scheduled for February 24–26, a course developed by Cranfield University in collaboration with TOPRA will examine how US regulatory procedures are applied to medical technologies. Offered by Cranfield University in the United Kingdom, the course is designed to enable attendees to leave with the capability to advise their organizations about ...