US OK's EndoGastric's transoral technology:
This article was originally published in Clinica
Representing its US market debut, EndoGastric Solutions has received FDA clearance for its transoral StomaphyX device for "incisionless" tissue approximation and ligation in the gastrointestinal tract. The Redmond, Washington firm, which is involved in modifying current open surgical and/or laparoscopic approaches by using transoral access instead of abdominal incisions, already markets the product in Europe.
You may also be interested in...
Novartis’s cancer drug has now been filed for multiple sclerosis in the US, armed with a priority review, and in Europe.
Aetion is also working with the US Food and Drug Administration and a number of biopharma companies on projects involving use of real-world evidence.
Increased fines and penalties are on the cards for manufacturing facilities that fail to comply with proposed new requirements.