A complete response letter (CRL) from the FDA delays a product's entry to the market by an average of 14 months. Companies that receive the letters take an average of seven months just to respond to them. Imagine how much you could save if you could anticipate the FDA's concerns and address them before the agency issues the complete response letter? Now you can.
Valencia, Calif.-based SetPoint Medical has hired Sagentia to develop a programming interface for a neuromodulation device designed to provide a lower-cost and lower-risk alternative to immunosuppressive drugs such as prednisone that treat chronic inflammatory diseases such as Crohn’s disease and rheumatoid arthritis.
The European Commission Dec. 5 granted AstraZeneca (AZ) European marketing permission for its Fluenz Tetra live attenuated intranasal influenza vaccine for patients age 2 to 18. The vaccine is sprayed into each nostril, where its weakened viral strains induce protective immunity.
Home » Sunshine Heart Announces Conditional Approval of IDE From the FDA for C-Pulse Heart Assist System
Sunshine Heart Announces Conditional Approval of IDE From the FDA for C-Pulse Heart Assist System
Sunshine Heart, a global medical device company focused on innovative technologies for moderate to severe heart failure, announced it has received conditional approval from the FDA for an investigational device exemption (IDE) for its flagship C-Pulse Heart Assist System. Equities