Neovasc (NSDQ:NVCN) said today that it plans to seek pre-market approval from the FDA for its Reducer angina device by the end of the year. In July, Vancouver-based Neovasc said it hoped the get the device on the U.S. market in early 2020 via a humanitarian device exemption. Reducer is designed to narrow the coronary sinus […]
Google to pay more than $2B for Fitbit
Fitbit (NYSE:FIT) today confirmed the rumor of an acquisition by Google parent Alphabet (NSDQ:GOOG), revealing that it accepted a $7.35-per-share cash offer worth about $2.1 billion. “More than 12 years ago, we set an audacious company vision – to make everyone in the world healthier. Today, I’m incredibly proud of what we’ve achieved towards reaching that goal. We […]
Endologix defends AFX stent grafts after FDA warning
Endologix (NSDQ:ELGX) moved to defend its AFX stent grafts after the FDA this week warned of the risk of endoleaks with the devices, which are used to treat abdominal aortic aneurysms. The FDA added the Irvine, Calif.-based company’s The AFX with Duraply and AFX2 to last year’s warning about the AFX with Strata device, citing data […]
Intersect ENT’s Q3 beats on sales, misses on earnings
Intersect ENT (NSDQ:XENT) this morning posted wider-than-expected losses but topped the consensus sales estimate with its third-quarter results. Menlo Park, Calif.-based Intersect reported losses of -$12.8 million, or -41¢ per share, on sales of $24.1 million for the three months ended Sept. 30. Get the full story at our sister site, Drug Delivery Business News
Hillrom tops estimates with fiscal Q4, 2019 numbers
Hillrom (NYSE:HRC) today posted fiscal fourth-quarter and full-year numbers that beat the consensus forecast all around. The Chicago-based medical products giant reported profits of $27.9 million, or 41¢ per share, on sales of $782.8 million for the three months ended Sept. 30, for a -69.1% bottom-line slide on sales growth of 3.1%. Adjusted to exclude […]
NuVasive gains on beat-n-raise Q3 numbers
NuVasive (NSDQ:NUVA) shares are up today after the spine implant maker reported beat-and-raise third-quarter results. San Diego-based NuVasive posted profits of $11.0 million, or 21¢ per share, on sales of $290.8 million for the three months ended Sept. 30, for a bottom-line slide of -30.9% on revenue growth of 20.2%. Adjusted to exclude one-time items, earnings […]
Integer bests Q3 earnings forecast despite plunging profits
Integer Holdings (NYSE:ITGR) today reported third-quarter earnings that beat the consensus forecast, despite a bottom-line slide of some -73%, and raised its earnings outlook for the rest of the year. The Plano, Texas-based medical device contract manufacturer said profits were down -73.2% to $30.6 million, or 92¢ per share, on a -0.5% top-line slip to $303.6 […]
Abiomed jumps on fiscal Q2 earnings beat
Abiomed (NSDQ:ABMD) shares got a pre-market jump today from fiscal second-quarter earnings that topped the consensus forecast once some $35 million in unrealized losses from its stake in Shockwave Medical (NSDQ:SWAV) were factored in. The Danvers, Mass.-based heart pump maker posted profits of $13.1 million, or 28¢ per share, on sales of $205.0 million for […]
Smith & Nephew beats on Q3 sales, raises outlook
Smith & Nephew (NYSE:SNN) today reported third-quarter revenues that beat the consensus forecast and raised its outlook on the rest of the year. The London-based orthopedics and wound care giant posted sales growth of 6.6% to $1.25 billion for the three months ended Sept. 28, compared with Q3 2018. Analysts were looking for sales of […]
Cardiovascular Systems sinks on fiscal Q1 earnings miss
Cardiovascular Systems (NSDQ:CSII) shares sank today after the medical device company missed the consensus earnings forecast for its fiscal first quarter.* Th St. Paul, Minn.-based company doubled its losses to -$5.8 million, or -17¢ per share, on sales growth of 14.6% to $64.5 million for the three months ended Sept. 30, compared with fiscal Q1 2019. […]
China approves Biotronik’s Orsiro drug-eluting stent
Biotronik said today that China’s National Medical Products Administration approved its Orsiro drug-eluting stent. Orsiro is a cobalt-chromium stent that elutes the drug sirolimus via the Berlin-based company’s Biolute bioabsorbable polymer coating. Biotronik said it plans to have Orsiro on the Chinese market “in the coming months.” Get the full story at our sister site, […]
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