The FDA accepts Edap SA's pre-market approval application for its Ablatherm prostate cancer treatment, as 2012 losses soar for the French medical device company.
Edap (NSDQ:EDAP) said the FDA accepted its pre-market approval application for its Ablatherm ultrasound prostate cancer treatment, backed by data from its Enlight investigational device exemption study.
The Vaulx-en-Velin, France-based medical device company also reported that its losses increased by a whopping 646% during the 2012, on an 8% sales increase.
The FDA approves Johnson & Johnson's 1st-of-a-kind Invokana diabetes drug, designed to flush unabsorbed sugar from the bloodstream.
The FDA approved a 1st-of-its-kind treatment for Type 2 diabetes, Johnson & Johnson's (NYSE:JNJ) Invokana, with the federal watchdog agency citing it as a pioneer in a new class of diabetes drug.
Sanuwave cuts 18 of 28 employees, helping to pare its 2012 losses by 38%.
Sanuwave Health (OTC:SNWV) laid off more than ⅓ of its workforce in its quest to pare its 2012 losses, according to a regulatory filing, shrinking from 28 employees to 10.
Kips Bay reports widening losses and shrinking sales for its 4th quarter, but the FDA's decision to allow full enrollment in the U.S. arm of the company's feasibility trial is an important turnaround for the device maker.
Medical device maker Kips Bay Medical (NSDQ:KIPS) saw widening losses and sinking sales during its most recent quarter, but the company marked an important win with FDA approval to complete full enrollment in the U.S. arm of a feasibility study.
AtriCure shares slide after it reports wider 2012 losses and misses Wall Street's expectations.
AtriCure (NSDQ:ATRC) reported wider losses for 2012 and missed Wall Street's expectations with its Q4 and full-year results, sending shares down on The Street last week.
The West Chester, Ohio-based medical device company posted losses of $2.0 million, or 12¢ per share, on sales of $18.4 million for the 3 months ended Dec. 31, 2012, for top-line growth of 9.6% and a loss reduction of 2.9%.
Diabetes management devices maker Insulet gets a Wall Street boost after reporting robust 2012 sales growth and winning FDA clearance for its new OmniPod insulin pump.
Medical device maker Insulet (NSDQ:PODD) got a boost from Wall Street last week after releasing its 4th quarter and full-year 2012 financial report.
The news sent PODD shares up 5.5% in a single day on Feb. 28 after the company hosted its earnings call with investors.
Shares of Hansen Medical are down after the medical device company reported wider 2012 losses and declines to issue guidance for 2013.
Hansen Medical (NSDQ:HNSN) managed to eke out a profit during the 4th quarter on the sale and licensing of some of its patents, but still posted wider losses for 2012, sending shares down YY% on Wall Street last week.