PharmaLeaders - Medical Devices News

BRIEF: MCS expands US deep vein thrombosis device sales [Globes, Tel Aviv, Israel]

Mon, 06 Sep 2010 19:33:00 +0000

Sept. 06--MCS Medical Compression Systems (DBN) Ltd. (TASE:MDCL) today announced that, during August, four more medical centers in the US chose the company's proprietary ActiveCare + SFT non-invasive device for the treatment of deep vein thrombosis. The medical centers are in Indiana, Minnesota, and Missouri.

MCS's share price rose 8.4 percent by mid-afternoon to NIS 3.56, giving a market cap of NIS 124 million.

MCS said that the four medical centers carry out 4,600 deep vein thrombosis procedures a year, and that the company's product will achieve a 25 percent penetration rate in the first year.

MCS CEO Adi Dagan said, "Without...

Nanostructures Made From Edible Materials Could Be...

Administrator — Mon, 06 Sep 2010 18:04:54 +0000

Sugar, salt, alcohol and a little serendipity led a Northwestern University research team to discover a new class of nanostructures that could be used for gas storage and food and medical technologies. And the compounds are edible. The porous crystals are the first known all-natural metal-organic frameworks (MOFs) that are simple to make...

...(Read whole news on source site)

SQI Diagnostics announces filings for celiac assay in US and Canada

Sun, 05 Sep 2010 16:46:00 +0000

Sep 05, 2010 (Datamonitor via COMTEX) -- SQI Diagnostics, a medical systems company, has announced that the FDA has received the company's 510(k) submission seeking marketing clearance in the US for SQI's IgX PLEX celiac assay and automated SQiDworks diagnostics platform.

In addition, SQI announced it has filed a class II medical device license application with Health Canada to permit the company to market the IgX PLEX celiac test and platform in Canada.

Claude Ricks, CEO of SQI Diagnostics, said: "Having already attained regulatory clearance for our IgX PLEX rheumatoid arthritis assay in combination with the SQiDworks platform, we are optimistic that...

Minnesotans in Congress weigh in on FDA changes [Star Tribune, Minneapolis]

Sun, 05 Sep 2010 07:08:00 +0000

Sept. 05--Up until three years ago, the medical device start-up NeuroVasx Inc. looked like it was on a trajectory to success.

The Maple Grove company raised $33 million and developed a product to treat very large brain aneurysms, which can lead to strokes. In 2007, the company submitted a 510k application to the Food and Drug Administration (FDA) -- a type of regulatory approval that requires the applicant to show that its product is similar to one already on the market.

But the company experienced numerous delays and received mixed signals as the FDA reviewed the cPax device. It has yet...

Weighing in on FDA changes [Star Tribune, Minneapolis]

Sat, 04 Sep 2010 18:04:00 +0000

Sept. 04--Up until three years ago, the medical device start-up NeuroVasx Inc. looked like it was on a trajectory to success.

But the company experienced numerous delays and received mixed signals as the FDA reviewed the cPax device. It has yet...