Click Therapeutics Anticipates Pharma Will Begin Developing Digital Drugs From Clinical Stage

FDA Draft Guidance And Exploding GLP-1 R&D Create New Horizons For Digital Therapeutics

Leading digital therapeutic maker’s CEO David Benshoof Klein and CMO Shaheen Lakhan discuss outlook on the DTx space, priorities going forward, and what makes Click a standout player in a changing game.

Medtech On The Brain
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Medtech Insight is honoring May and June awareness months for mental health, Alzheimer’s and brain health by speaking with industry leaders about rising innovations to address neurological diseases and mental health, the regulatory and investment climate, reimbursement, and more.

Draft guidance issued last year by the US Food and Drug Administration and the GLP-1 agonist drug boom are among...

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Keep up with the top medtech business and regulatory news.

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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.

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-DigitalTechnologies (Premium-1): Optimal Imaging Frequency After Spine SBRT: Balancing Surveillance and Patient Care

 
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A Deep Dive into Evidence-Based Guidelines, Clinical Considerations, and Evolving Practices for Post-SBRT Imaging in Spinal Tumor Patients

J&J MedTech Keeps Up Cardiovascular Momentum With Shockwave E8 Launch In US

Tim Schmid, executive VP and worldwide chairman of J&J MedTech, expects Shockwave, acquired in April, and Abiomed, purchased in late 2022, to be “long-term gems” for the company. Cardiovascular is among higher-growth segments where J&J has concentrated investments in recent years, along with robotic surgical systems.

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Test Focus Of Tariff Conversations Shifts To Stability, AdvaMed Says - Clone

 
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AdvaMed president Scott Whitaker said the group is focused on the need for tariff stability in conversations with the Trump administration. The organization remains optimistic about other policy areas. New chairman and ResMed CEO Mick Farrell laid out his five priorities.

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Class III devices and panel-track supplements approved by US FDA’s Center for Devices and Radiological Health. Data derived from FDA.gov. Updated weekly.

Test Focus Of Tariff Conversations Shifts To Stability, AdvaMed Says

 
• By 

AdvaMed president Scott Whitaker said the group is focused on the need for tariff stability in conversations with the Trump administration. The organization remains optimistic about other policy areas. New chairman and ResMed CEO Mick Farrell laid out his five priorities.