FDA Clears Stereotaxis Guidewire for Peripheral Chronic Total Occlusions
Conventional catheters are designed to be operated mechanically from their proximal or back end. They are necessarily stiff to allow for steering through a series […]
Month: August 2008
NexMed Gets Nailed, Stock Price Derails
On Tuesday, NexMed announced that it would shelve its previously filed NDA for an onychomycosis treatment (NM100060) following disappointing Phase III clinical results. Onychomycosis, or […]
[Video] Interview with Dr. Irwin Goldstein, Director of Sexual Medicine at Alvarado Hospital
San Diego Sexual Medicine at Alvarado Hospital, led by physician Irwin Goldstein, attempts to improve sexual health through the prevention, diagnosis, treatment, and rehabilitation of […]
[Video] POM Wonderful: Seriously Profitable Science-Backed Marketing
POM Wonderful was founded by Stewart and Lynda Rae Resnick, who purchased a 100-acre pomegranate orchard in 1987. The company launched its namesake juice in […]
Kensey Nash Q4: A Well Oiled Machine
Revenues at Kensey Nash grew to a record $22 million in the company’s latest quarter, a 29% increase over the same period last year. Net […]
Celleration Raises $30 Million to Accelerate Sales & Marketing
Ultrasound wound healing device developer Celleration has successfully completed a Series D financing, raising $30 million. Heron Capital, Venture Investors and Clarian Health led the […]
[Video Profile] Interview with Joseph Galli, President & CEO of Haemacure
Haemacure is developing human biological adhesives, hemostats and therapeutic proteins. The company’s research and development efforts are driven by a proprietary plasma protein extraction process. […]
Thermage Considers Third Party Acquisition at Huge Premium
Thermage has received an unsolicited takeover bid from an as-yet-unnamed third party calling for the acquisition of all outstanding shares at $5.50 a piece. That […]
Medtronic Alleges Patent Infringement by NuVasive
Device giant Medtronic Sofamor Danek has filed a complaint against NuVasive, alleging patent infringement by certain NuVasive products. Nuvasive is in the process of reviewing […]
Predicting the End of PreMD: FDA Rejects PREVU 510(k)
The FDA has upheld its decision regarding PreMD’s not substantially equivalent letter received in connection with the company’s 510(k) submission for an expanded regulatory claim […]