The FDA yesterday unveiled a plan containing 25 actions it intends to implement this year to improve the most common path to market for medical devices, the 510(k) process. Key actions include: streamlining the de novo review process for certain innovative, lower-risk medical devices; clarifying when clinical data should be submitted in a premarket submission, guidance that will increase the efficiency and transparency of the review process; and establishing a new Center Science Council of senior FDA experts to assure timely and consistent science-based decision making.(Medical Device Daily)

A home glaucoma test developed by an engineer at the University of Arizona (Tucson) might someday render unnecessary the traditional testing method that requires a visit to the ophthalmologist. The new hand-held device involves a system of micro-force sensors, specially designed microchips, and math-based program. Best of all – the UA College of Engineering says the easy-to-use probe that gently rubs the eyelid can eventually be used at home. (Medical Device Daily)

W. L. Gore & Associates (Flagstaff, Arizona) said it has received FDA approval to market its C3 delivery system to deploy the Gore Excluder AAA Endoprosthesis as a minimally invasive treatment for an abdominal aortic aneurysm (AAA). (Medical Device Daily)

Sometimes the most debilitating medical conditions can be resolved by a very simple solution. Most often such solutions come from the academic setting, as is the case for a potential new drug-delivery device invented by researchers at the Massachusetts Institute of Technology (MIT; Cambridge). (Medical Device Daily)

The year 2010 was quite possibly one of the toughest years in med-tech history for startup companies as the venture capital community began to reserve investment funds for more developed and later-stage companies. But that hasn't stopped one early-stage company from entering 2011 hopeful of raising the capital needed to support its innovation. (Medical Device Daily)