Start-Up Spotlight: Cognoa Seeks Breakthrough In Early Diagnosis Of Autism And ADD
US FDA recently granted Cognoa’s autism diagnostic device a Breakthrough Device designation to accelerate its efforts to get the first FDA-cleared medical device for the early diagnosis of autistic spectrum disorder (ASD) to market. The average age of ASD diagnosis is about four years old, but extensive clinical research has shown that earlier diagnosis of ASD can improve outcomes over the child’s lifetime. Cognoa’s system is intended to allow primary care physicians to diagnosis ASD in the children as young as 18 months.
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US FDA issued a final guidance that sets out requirements for its new Breakthrough Devices Program mandated by Congress. Under the new program, which replaces the Expedited Access Pathway, sponsors have more certainty about how quickly they will get responses from the agency and fewer requirements when setting up early interactions.
Cardiovascular Sales & Earnings Roundup: Medtronic TAVR Disappoints While Abbott And Boston Scientific See Structural Success In 2019
The top five cardiovascular device companies, as ranked by Medtech Insight’s MTI 100, have reported their sales and earnings for the last quarter of the calendar year 2019. Here are the highlights from the most recent presentations from Medtronic, Abbott Laboratories, Boston Scientific, Edwards Lifesciences and Terumo.
Digital Surgery, a London-based developer of surgical artificial intelligence, analytics, digital education and training solutions, will join Medtronic’s surgical robotics business within its minimally invasive therapies group.