Apollo Endosurgery spent $90 million-plus nearly two years ago to acquire the Lap-Band gastric band weight loss system and the in-development Orbera intra-gastric balloon from Allergan (NYSE: AGN). A well-trained, international sales force also came with the acquisition. Recently, I asked founder, president & chief commercial officer Dennis McWilliams if the investment was worth it, […]
My diagnostic odyssey: The limits of genetic testing
I am on a “diagnostic odyssey.” That term was unfamiliar to me until I spoke with Joy Larsen Haidle, president of the National Society of Genetic Counselors, whose members help patients determine whether genetic testing for diagnostic purposes makes sense for them. I have an epileptic condition, but despite repeated visits with specialists over several […]
Veniti raises $17m for Vici venous stent
Veniti said it nailed down a $17 million Series C financing it plans to use to advance testing and commercialization of its Vici venous stent system. The St. Louis-based medical device company said the round involved both debt and equity funding. Previous investors Baird Capital, Tekla Healthcare and Tekla Life Science Investors led the equity […]
SynCardia wins FDA nod for destination therapy trial
SynCardia plans to test its artificial heart as a permanent implant rather than a placeholder for donor transplants in 19 patients. The Arizona company said it won the FDA’s approval to move ahead with the clinical study of its temporary Total Artificial Heart as a permanent transplant option. This is a big advance forward for […]
The FDA issues a warning letter to AngioDynamics subsidiary Navilyst Medical Systems on reports that some of its catheters shipped with hairs in their packaging.
The FDA slapped AngioDynamics (NSDQ:ANGO) subsidiary Navilyst Medical Systems with a warning letter for selling some long-term-use catheters contaminated by hair and other foreign matter and for not properly addressing the issue, among other quality issues. As many as 55 complaints came in between May 2012 and May 2014 alleging the presence of hair in catheter […]