News We’re Watching: ReCor And Medtronic Head To RND Panel, Clearances For Anika And Sequel, ZimVie And Brainlab Partner

This week, the US FDA geared up for a renal denervation panel meeting; a microbiology panel meeting was announced; and a hyaluronic acid patch to promote rotator cuff healing, a novel spiral tampon, and a tibial neuromodulation device to treat incontinence all won FDA clearance. 

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• Source: Medtech Insight

The long quest for two companies trying to bring renal denervation technology to the US market may be finally coming to a satisfying conclusion.

Renal denervation is a catheter-based procedure intended to reduce blood pressure in people with uncontrolled hypertension. By ablating the peri-arterial...

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Digital Health Roundup: Digital Therapeutics Navigate GLP-1, Immersive Gaming; DHCoE AI Framework; Hello Heart

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.

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News We’re Watching: New FDA Approvals For Breast Implant, Colon Cancer Test, Imaging Agent; TAP Expansion, AI Standards

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.  

MI-PolicyAndRegulation (Free-1): Biliary Atresia Linked to Autism and Neurodevelopment Delays

 
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Children with biliary atresia (BA) exhibited neurodevelopmental deficits and increased autism traits, with earlier surgery linked to better general neurodevelopment.

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News We’re Watching: New FDA Approvals For Breast Implant, Colon Cancer Test, Imaging Agent; TAP Expansion, AI Standards

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.  

MI-PolicyAndRegulation (Free-1): Biliary Atresia Linked to Autism and Neurodevelopment Delays

 
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Children with biliary atresia (BA) exhibited neurodevelopmental deficits and increased autism traits, with earlier surgery linked to better general neurodevelopment.

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Nancy Tests SPARC-931 Part 7

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