Execs On The Move: June 2022

An interactive view of medtech executive changes from the month of June.

Executives On The Move

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Guardant’s Multi-Cancer Detection Test Granted FDA Breakthrough Device Designation

 

Guardant Health’s methylation-based blood test – Shield MCD – showed a specificity of 98.6% and sensitivity of 75% across eight cancer types in its clinical validation data presented at ASCO.

DeepLook AI Imaging Provides A Deeper Look At Dense Breast

 

DeepLook Medical recently announced the commercial rollout of DL Precise, an AI-powered imaging platform that enhances breast cancer screening, at major healthcare institutions across the US.

First AI Breast Cancer Prediction Platform Receives FDA Authorization

 

Clairity’s "first-in-class" mammography-based AI screening tool, Clairity Breast, provides "equitable risk assessments," expanding access to lifesaving early detection for breast cancer, said company founder Connie Lehman.

Abbott Announces FDA Approval Of Tendyne Transcatheter Mitral Valve Replacement System

 
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Abbott received the US FDA nod for its Tendyne system, offering a minimally invasive alternative to replace the valves of patients with severe mitral valve disease who are at risk for open-heart surgery.

More from Medtech Insight

DeepLook AI Imaging Provides A Deeper Look At Dense Breast

 

DeepLook Medical recently announced the commercial rollout of DL Precise, an AI-powered imaging platform that enhances breast cancer screening, at major healthcare institutions across the US.

First AI Breast Cancer Prediction Platform Receives FDA Authorization

 

Clairity’s "first-in-class" mammography-based AI screening tool, Clairity Breast, provides "equitable risk assessments," expanding access to lifesaving early detection for breast cancer, said company founder Connie Lehman.

Final Curtain For LDTs? FDA Will Not Appeal District Court Decision To Vacate Final Rule

 

The US FDA has given up on its effort to regulate lab-developed tests as medical devices, at least for now. The agency will not appeal a decision from the Eastern District of Texas that tossed out the FDA’s final rule, leaving the agency with few cards.