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TCT 2019 Roundup: Medtronic’s Resolute Onyx non-inferior to Biosensors...
A study comparing the Resolute Onyx drug-eluting stent from Medtronic (NYSE:MDT) and the BioFreedom stent made by Biosensors International (PINK:BSNRY) showed the Medtronic device to be non-inferior...
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Valeritas jumps on $25m refi, Q3 prelims
Valeritas (NSDQ:VLRX) said today that cut its debt load by $25 million in a refinancing move and released its third-quarter preliminary results, sending its share price up on Wall Street in early...
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Dexcom wins FDA clearance for G6 Pro CGM
Dexcom (NSDQ:DXCM) said today that it won 510(k) clearance from the FDA for its G6 Pro continuous glucose Monitor for diabetic patients ages ages two years and up. The San Diego-based company said the...
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iRadimed clears 5-year-old warning letter
iRadimed (NSDQ:IRMD) last week finally cleared a five-year-old warning letter from the FDA issued over quality issues with its IV infusion pumps. The August 2014 warning letter chided Winter Springs,...
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Frequency Therapeutics launches hearing loss trial, gains the fast track at FDA
Frequency Therapeutics (NSDQ:FREQ) said today that it launched a Phase 2a study and won fast-track designation at the FDA for its regenerative hearing loss drug. The fast-track program aims to speed up...
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BD to shutter Minnesota Lutonix plant, layoffs ahead for 53
Becton Dickinson (NYSE:BDX) is planning to close a Minnesota plant that makes its Lutonix drug-coated balloon next year, as the company looks to consolidate its peripheral intervention business. The...
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DarioHealth beats forecast with Q3 results
DarioHealth (NSDQ:DRIO) posted lower-than-expected net losses during the third quarter and met the consensus revenues forecast. The Israeli company, which makes mobile phone-compatible blood glucose...
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Pixarbio CEO Reynolds convicted in $13m investor fraud case
Pixarbio founder & CEO Frank Reynolds reportedly faces two decades behind bars after a jury yesterday convicted him of defrauding investors of nearly $13 million. Federal authorities arrested...
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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...
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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...
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