Edwards Lifesciences Corp.
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Latest From Edwards Lifesciences Corp.
Medtech Insight's News We're Watching highlights some recent business and R&D developments you may have missed. This week, GE Healthcare and Biofourmis announced a deal to collaborate on virtual care; Cleerly touts a new CPT code for its Ischemia cardiac diagnostic software; Boston Scientific announced how it plans to pay for Axonics; a Wells Fargo survey suggests the market for transcatheter tricuspid valve repair and replacement will grow faster than previously imagined; Virtual Incision earns FDA de novo authorization for its MIRA miniaturized surgical system for colectomy procedures; and MMI and Fabric announce major financing rounds.
An FDA advisory panel will discuss Abbott’s PMA for the TriClip G4 transcatheter tricuspid valve repair device on 13 February. The group’s discussion will likely focus on the lack of a clear mortality or hospitalization benefit in the TRILUMINATE pivotal trial.
Edwards' Evoque is the first transcatheter therapy to receive FDA approval for the treatment of tricuspid regurgitation. The FDA-approved labeling says it can improve patients' "health status" but the company may be able to soon upgrade that indication to include a mortality benefit claim, which could give Evoque an important advantage over tricuspid valve repair devices.
Medtech Insight's News We're Watching highlights medtech industry developments we are following: Intuitive announced an FDA filing for its da Vinci 5 surgical robot; Roche hits at CGM plans; Abbott launches a new smaller rechargeable deep brain stimulator; CroiValve starts transcatheter tricuspid valve trial; ReWalk rebrands as Lifeward; and more news you may have missed.
- Implantable Devices
- Infusion Therapy Equipment and Supplies
- Monitoring Equipment & Devices
- Surgical Equipment & Devices
- Other Names / Subsidiaries
- CardiAQ Valve Technologies, Inc.
- CAS Medical Systems, Inc.
- Embrella Cardiovascular, Inc.
- Harpoon Medical, Inc.
- Percutaneous Valve Technologies, Inc.
- Valtech Cardio, Ltd.
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