FDA premarket approval

Scientist working in the lab at Helix. Photo courtesy of Helix. 

By Laura Lovett June 15, 2018
In the last few years consumer genomics has grown in both its offerings and legitimacy. The industry that was once best known for telling clients if they were Italian or Hungarian is now securing its foothold within the healthcare space.    Whether it is uniting women switched at birth 72-years prior or settling neighborly feuds, consumer genomics have caught the public’s interest. The highest...
By Jonah Comstock June 4, 2018
As of tomorrow, individual genetic risk tests are officially exempt from requiring 510(k) premarket approval, provided the company offering the test has gone through a one-time premarket review of its testing apparatus and at least one test. The notice, which will be officially published tomorrow in the Federal Registry, finalizes a guidance that was originally proposed in November 2017. "Today,...
By Jonah Comstock November 9, 2016
Senseonics, the Germantown, Maryland-based company which went public in January and is working on a longterm implantable continuous glucose monitor, has submitted its PMA application to the FDA, President and CEO Tim Goodnow said on the company's third quarter earnings call last week. In addition, the company continues to work on a second generation device and its first pediatric clinical trial...
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