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CardioMEMS, Inc.

http://www.cardiomems.com

Latest From CardioMEMS, Inc.

Janssen’s Amivantamab Combo Shows Promise In First-Line NSCLC

Janssen presents highly encouraging interim results at ESMO from the CHRYSALIS study with a combination of amivantamab and lazertinib. Based on the data, the global Phase III MARIPOSA study, which will assess the combo versus blockbuster Tagrisso, will begin next month including in South Korea, home to lazertinib's originator. 

Clinical Trials Research & Development

FDA Approves Guardant’s Guardant360 CDX Comprehensive Genomic Profile

The liquid-biopsy test is also a companion diagnostic for osimertinib, AstraZeneca’s drug for non-small cell lung cancer.

Approvals In Vitro Diagnostics

Guardant Will Collaborate With Janssen On Lung Cancer Companion Diagnostic

The companies expect the Guardant360 CDx liquid-biopsy test to identify patients who will benefit from amivantamab, Janssen’s investigational drug for non-small cell lung cancer.

Deals Cancer

St. Jude Warning Letter Spotlights CAPA Flaws At CardioMEMS Unit

The warning letter highlights validation and recordkeeping problems at the Atlanta manufacturing facility for the CardioMEMS heart failure remote monitoring system, but it is not expected to affect device availability.

Medical Device
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