The expanded indication for Edwards' Sapien XT and Sapien 3 arrives about when the company had predicted.
Edwards Lifesciences Corp. has beaten its rivals to yet another milestone in the development of transcatheter aortic valve replacement (TAVR) systems with the first US FDA-approved indication for intermediate-risk patients.
The agency announced Aug. 18 that it approved an expanded indication for Edwards' Sapien XT and Sapien 3 TAVR systems...
In this week’s Digital Health Roundup, Medtech Insight’s Ryan Nelson highlights Click Therapeutics’ FDA-cleared digital therapeutics (DTx) for depression and Sinaptica Therapeutics’ personalized neuromodulation for Alzheimer’s patients. Marion Webb discusses her interview with MindMaze’s John Krakauer on their gaming-focused DTx to help people recover from serious brain injuries. Elizabeth Orr introduces new voting members of the new Digital Health Advisory Committee and Natasha Barrow discusses Hello Heart’s new symptom-tracking feature in their heart-focused app.
This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.
Spain has one of the highest incarceration rates in Europe, with 160 individuals imprisoned per 100,000 residents. In 2020, 43,494 people were incarcerated in facilities not managed by regional health authorities — essentially all regions except Catalonia, the Basque Country, and Navarra.
Patrick Alexandre, Crossject CEO, discusses crucial developments happening for Zeneo, a needle-free injector, functioning intramuscularly to administer medication in a tenth of a second.
This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.
