NovaDel Investors Restless as FDA Extends Approval Timeframe for Zolpimist
The FDA has requested an extension of “up to three months” in order to complete the review of the NovaDel’s Zolpimist Oral Spray for the […]
Month: September 2008
[Video Profile] Arterial Remodeling Technologies
Arterial Remodeling Technologies (ART) is developing bioresorbable peripheral and coronary polymer stents that promote the natural remodeling of an injured artery after angioplasty. ART’s bioresorbable […]
Biolase: Checking In on the Turnaround
In February, I reported that a turnaround at Biolase was underway. Improved relations with Henry Schein, a key distributor, were largely responsible for the upturn. […]
Elemé Medical to Launch SmoothShapes Internationally
As the bane of women the world over, treatment for cellulite is a healthcare holy grail. Elemé Medical has developed the FDA-cleared SmoothShapes system, a […]
Spectranetics: FDA Voices Concern Over SALVAGE Trial Safety
Spectranetics can’t catch a break. The Colorado Springs-based manufacturers of excimer lasers saw its share price plummet after the Fed issued search warrants so that […]
2008 Health Tech Investment Forum: Bringing Together Investors and Technology Providers
The Health Tech Investment Forum, taking place Tuesday, September 30th in NYC, will bring together some of the biggest names in healthcare technology. The one […]
With MTX-100, BSD Medical Goes Head-to-Head with RF Ablation Technologies
BSD Medical, a developer of microwave systems used to treat cancer, has received FDA 510(k) clearance for its MicroThermX-100 Microwave Ablation System (MTX-100). MTX-100 is […]
MiCardia’s Dynaplasty Technology Gets 510(k)
MiCardia Corporation, developer of treatments for late-stage congestive heart failure and mitral heart valve disease, announced 510(k) clearance this week for its Dynaplasty Annuloplasty Band […]
What’s Next for NexMed?
After NexMed announced it would shelve its previously filed NDA for a toe nail fungus (TNF) treatment following disappointing Phase III clinical results, shares of the […]
Investors Flee Spectranetics as Fed Investigates
In an announcement that sent investors clamoring for cover, the U.S. District Court of Colorado served Spectranetics with a search warrant. It seems that both […]