The Framingham, Mass.-based device maker's non-surgical intravesical system gets the OK to hit the market in the European Union.
Solace Therapeutics Inc. won CE Mark approval in the European Union for its intravesical system to treat female stress urinary incontinence.
The Framingham, Mass.-based medical device maker said its device is a small, quarter-sized balloon that floats inside the bladder. Inserted via catheter during an out-patient procedure, the balloon is designed to relieve the pressure fluctuations within the bladder that lead to incontinence.
Warren Watson, a 30-year Medtronic Inc. employee with family connections to founder Earl Bakken, is...
Quidel Corp. wins Food & Drug Administration 510(k) clearance for its chorionic gonadotropin-...
Ann Arbor, Mich.-based HistoSonics Inc. snags former Food & Drug Administration commissioner Dr....
The Food & Drug Administration releases a list of the medical devices it granted 510(k) clearance...
A federal grand jury indicts former Spectranetics CEO John Schulte, two other executives and a...