Biotech FDA Approved

Teva launches generic EpiPen Jr.

Released on August 21, 2019

Teva (NYSE:TEVA) today announced that its FDA-approved generic EpiPen Jr. auto-injector is available…

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FDA Approved Neuro

Boston Scientific wins FDA nod for MR-safe Vercise Gevia DBS

Released on August 20, 2019

Boston Scientific (NYSE:BSX) said yesterday that it won FDA approval for MR-conditional labeling on its Vercise Gevia deep-brain stimulation device for treating…

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FDA Approved Neuro

CVRx’s Barostim Neo system earns FDA approval

Released on August 19, 2019

CVRx said today it won FDA approval for its Barostim Neo system, the world’s first heart failure…

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FDA Approved Spine

FDA approves Zimmer Biomet’s pediatric spinal tether for scoliosis

Released on August 19, 2019

Zimmer Biomet (NYSE:ZBH) said it received the first FDA approval for a spinal tether device intended to correct pediatric scoliosis….

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FDA Approved MedTech

Medtronic wins FDA approval for new extended-wear infusion set

Released on August 16, 2019

Medtronic (NYSE:MDT) said it earned investigational approval from the FDA to proceed with a trial for a new extended-wear infusion set…

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Cardiology FDA Approved

BREAKING: FDA approves TAVR valves for low-risk patients

Released on August 16, 2019

The FDA today expanded the approval for replacement heart valves made by Medtronic (NYSE:MDT) and Edwards Lifesciences (NYSE:EW) to include patients at low risk from open heart surgery…

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Biotech FDA Approved

Powder-Delivery Device Approved for First and Only Nasally Administered Glucagon

Released on July 31, 2019

A ready-to-use nasal drug delivery device for powder formulations is being used for Eli Lilly’s Baqsimi, which the drug maker calls the first and only…

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Biotech FDA Approved

FDA approves delivery system for Intersect ENT’s Propel implant

Released on July 26, 2019

Intersect ENT (NSDQ:XENT) said today that it won FDA approval for a new delivery system for its…

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FDA Approved MedTech

Med-El USA lands first FDA approval for single-sided deafness implant

Released on July 23, 2019

Med-El USA said today that the FDA has approved its cochlear implant for …

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FDA Approved Structural Heart

Abbott Receives U.S. Approval of Next-generation MitraClip G4

Released on July 17, 2019

Abbott has received U.S. Food and Drug Administration (FDA) approval for the most advanced MitraClip heart valve repair device to treat mitral regurgitation…

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FDA Approved

Teva wins FDA approval for AirDuo Digihaler for asthma

Released on July 16, 2019

Teva (NYSE:TEVA) yesterday said that it received FDA approval for its…

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CE Mark FDA Approved

INSIGHTEC Neuro with GE 3 Tesla MRI Now Approved in U.S., Europe

Released on July 16, 2019

INSIGHTEC, an Israeli firm, and GE Healthcare have won FDA approval and the European CE mark for the…

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