Annette Boyle
Staff Writer at BioWorld
Editor at BioWorld MedTech
Experienced medical writer and continuing medical education consultant with Yale MBA.
Articles
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1 week ago |
bioworld.com | Annette Boyle
Elixir granted CE mark for Lithix IVLReceipt of EU MDR CE mark may not be a magic potion, but Elixir Medical Corp. is certainly feeling a boost from the regulatory nod for its mechanical Lithix hertz contact intravascular lithotripsy system for treatment of moderate to severely calcified coronary artery lesions. Simultaneously, the company reported the launch of Lithix and completion of first cases in Italy, France and Germany. BioWorld MedTech Regulatory Cardiovascular Europe EMA
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1 week ago |
bioworld.com | Annette Boyle
Edwards lands first CE mark for transfemoral mitral valve replacementEdwards Lifesciences Corp.’s Sapien M3 secured CE mark for its Sapien M3 mitral valve replacement system for transfemoral treatment of patients with mitral valve disease who are ineligible for surgery or transcatheter edge-to-edge repair. Sapien M3 is indicated for individuals with symptomatic moderate-to-severe or severe mitral valve regurgitation. BioWorld MedTech Regulatory Cardiovascular TMVR Europe U.S. EMA
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1 week ago |
bioworld.com | Annette Boyle
FDA clears Dexcom G7 15 DayThe battle to claim the continuous glucose monitor with the longest wear time continues with Dexcom Inc.’s G7 15 Day continuous glucose monitor gaining U.S. FDA clearance on April 10 for adults with diabetes. The company said it now takes the lead with the 15-day duration, but Abbott Laboratories also offers 15 days of useful life for its Freestyle Libre 3 plus. BioWorld MedTech Regulatory Diabetes Continuous glucose monitor (CGM) U.S. 510(k) FDA
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2 weeks ago |
bioworld.com | Annette Boyle
FDA clears path for Boston Sci’s Bolt IVL to challenge J&J’s ShockwaveBoston Scientific Corp.’s up to $664 million acquisition of Bolt Medical Inc. closed just days after Bolt secured U.S. FDA 520(k) clearance for its intravascular lithotripsy (IVL) system, positioning Boston Sci to challenge Johnson & Johnson’s Shockwave IVL system, which has been the only player in the market. BioWorld MedTech Regulatory Cardiovascular U.S.
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2 weeks ago |
bioworld.com | Annette Boyle
Many med-tech company supply chains protected from tariffsIn the wake of the pandemic, many leading med-tech companies took steps to on-shore and near-shore manufacturing, a move that could protect significant numbers of players from the worst of the effects of the tariffs announced by the Trump administration last week. BioWorld MedTech Europe U.S. Policy Trade
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Does dude doing the play-by-play on @WElite8 on ABC think he's on the radio? Can he breathe a little more so the women can add the insight that makes it interesting? ESPN is so much better
“The cost of apathy is life, but the price of life is as small as an act of kindness. I am a life preserved by the kindness that was offered to me by others when I could not produce kindness for myself.” Harry Miller @h_miller76
RT @ananavarro: Oof! This was hard to watch. I’ve known @chefjoseandres for many years and am proud to call him a friend. He’s seen awful…
