Weekly Roundup 2.20.15

Friiiiiiggggggiiiiiiiddddd.  I realize anyone who doesn’t live in the Northeast can’t really complain, but winter finally woke up in the capital of our nation. Last week I took a picture of green daffodil sprouts coming up from the grounds of the library in my neighborhood and remarked on Facebook that it was a harbinger of Spring. This week, after snow that came horizontally instead of vertically, followed by serious winds and subzero temperatures, I can only think that those daffodils are sorry now. Especially given a forecast calling for more heavy snow.

But we continue to look on the bright side and are comforted by the fact that Daylight Savings is now only 16 days away.  Yep. And in the meantime, here is a bit of what happened this week that was noteworthy:

  • Approval of First DTC Genetic Test – FDA made two announcements in one this week when it issued a release regarding the fact that the agency was clearing for marketing the first direct-to-consumer genetic test so that a person could determine if they carry the gene variant for Bloom syndrome. The announcement is newsworthy in many respects – first and most obvious being the approval itself. Also within the announcement, FDA also stated that it was minimizing the regulatory pathway for the device by making it a Class II designation and exempting these devices from premarket review. According to the company release, test results will not be available until the company “completes the regulatory process for additional test reports and can offer a more comprehensive product offering.”
  • Scientific Report of Dietary Guidelines CommitteeHHS announced this week that the 2015 Dietary Guidelines Committee had released its scientific report which forms the basis for this year’s guidelines. The report has been making many headlines on what is good and what is bad in our diets with the perennial news that what we are doing is not working very well – we are getting low intakes of key food groups and too much in the way of sugar. The Executive Summary can be found here.  Obesity is prevalent. Comments can be submitted through April 8 here.
  • FDA Approves Closure System to Treat Vericose Veins – The VenaSeal Closure System was approved by FDA this week for the treatment of vericose veins by sealing the affected superficial veins with an adhesive agent, the first treatment to do so, providing a new treatment option for the condition.  FDA reviewed the premarket application as a Class III device.

That’s it for me this week folks.  I think it is a good weekend for French Onion Soup and fireplaces and good books indoors.  Take care.

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