New cholesterol test gets FDA clearance:

US company Polymer Technology Systems has received US FDA clearance for its HDL-cholesterol test, for sale over the counter. The test strip is part of the BioScanner 2000 personal blood chemistry system, designed for the management of diabetes and its complications. The procedure encapsulates a multi-channel analyzer, and disposable test strips, allowing the user to apply a small drop of blood onto a test strip and insert the strip into the analyzer, boasting results in a minute or less.

US company Polymer Technology Systems has received US FDA clearance for its HDL-cholesterol test, for sale over the counter. The test strip is part of the BioScanner 2000 personal blood chemistry system, designed for the management of diabetes and its complications. The procedure encapsulates a multi-channel analyzer, and disposable test strips, allowing the user to apply a small drop of blood onto a test strip and insert the strip into the analyzer, boasting results in a minute or less.

More from Archive

More from Medtech Insight

Even ‘Small’ Leaks After Left Atrial Appendage Occlusion Raises Stroke Risk, Study Finds

 

A Japanese study of Watchman LAA closure devices found that leaks of any size after implantation raise the risk of stroke. The study comes shortly after the US FDA issued an early alert for the Watchman access systems.

23andMe Genetic Tests Among 12 New FDA Classifications

 
• By 

A late-August batch of device classifications from the US FDA includes genetic tests from 23andMe, hand-held spinal surgery tools, and several IVDs.

German Hospital Reform Risks Spiraling Out Of Control

 
• By 

Amendments to Germany’s – barely in force – health reform law will be decided after the summer break. The new DRGs payments plan and service groups will be reviewed, but critics fear for the law’s future.