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Brad Perriello

Neovasc to pursue PMA this year for Reducer

November 1, 2019 By Brad Perriello

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 […]

Filed Under: Cardiovascular, Featured, Food & Drug Administration (FDA), Pre-Market Approval (PMA) Tagged With: neovasc

Google to pay more than $2B for Fitbit

November 1, 2019 By Brad Perriello

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 […]

Filed Under: Digital Health, Featured, Mergers & Acquisitions, Wall Street Beat Tagged With: Alphabet (Google), Fitbit

Endologix defends AFX stent grafts after FDA warning

November 1, 2019 By Brad Perriello

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 […]

Filed Under: Featured, Food & Drug Administration (FDA), Stent Grafts Tagged With: Endologix

Intersect ENT’s Q3 beats on sales, misses on earnings

November 1, 2019 By Brad Perriello

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

Filed Under: Drug-Device Combinations, Featured, MassDevice Earnings Roundup, Wall Street Beat Tagged With: intersectent

Hillrom tops estimates with fiscal Q4, 2019 numbers

November 1, 2019 By Brad Perriello

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 […]

Filed Under: Featured, Hospital Care, MassDevice Earnings Roundup, Wall Street Beat Tagged With: Hillrom

NuVasive gains on beat-n-raise Q3 numbers

October 31, 2019 By Brad Perriello

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 […]

Filed Under: Featured, MassDevice Earnings Roundup, Spine, Wall Street Beat Tagged With: Nuvasive

Integer bests Q3 earnings forecast despite plunging profits

October 31, 2019 By Brad Perriello

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 […]

Filed Under: Contract Manufacturing, Featured, MassDevice Earnings Roundup, Wall Street Beat Tagged With: integer

Abiomed jumps on fiscal Q2 earnings beat

October 31, 2019 By Brad Perriello

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 […]

Filed Under: Cardiovascular, Catheters, Featured, MassDevice Earnings Roundup, Wall Street Beat Tagged With: Abiomed

Smith & Nephew beats on Q3 sales, raises outlook

October 31, 2019 By Brad Perriello

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 […]

Filed Under: Featured, MassDevice Earnings Roundup, Orthopedics, Wall Street Beat, Wound Care Tagged With: Smith & Nephew

Cardiovascular Systems sinks on fiscal Q1 earnings miss

October 30, 2019 By Brad Perriello

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. […]

Filed Under: Cardiovascular, Featured, MassDevice Earnings Roundup, Wall Street Beat Tagged With: Cardiovascular Systems Inc.

China approves Biotronik’s Orsiro drug-eluting stent

October 30, 2019 By Brad Perriello

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, […]

Filed Under: Drug-Eluting Stents, Featured, Regulatory/Compliance Tagged With: Biotronik

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