In the blink of an eye, the medtech industry exited its spring slump and neared its all-time best performance levels. MassDevice‘s MedTech 100 Index offered signs of a rebound last week and has built on that momentum, registering a final tally of 109.39 points on April 9. That represents a 2.9% increase from the 106.26-point mark […]
LumiraDX
DTW Podcast: Herrera on how military lessons led to Medtech career; Ulmer ready to redo landmark FDA survey
In this week’s podcast, Derek Herrera explains how a serious battle injury he received while leading Marines in Afghanistan led him to build a career in medtech. Herrera has founded two companies – Spinal Singularity and Habit Camera – to create devices that can improve and save the lives of people who need help the […]
LumiraDx to start trading on Nasdaq through $5B SPAC deal
CA Healthcare Acquisition Corp.— a special purpose acquisition company — announced today that it entered a merger agreement with LumiraDx that will take the company public. London-based LumiraDx, a point-of-care diagnostics developer, will merge with CAHC with the combination reflecting a value of $5 billion for Lumira’s existing equity, according to a news release. Since […]
LumiraDx warns on false-positives with SARS-CoV-2 antigen test
LumiraDx issued an urgent device recall regarding a software update for its SARS-CoV-2 antigen test. The company received a customer complaint regarding a suspected false-positive result with the antigen test on Dec. 29, 2020. An investigation into the complaint identified a manufacturing issue that resulted in a small number of sequential test strips in certain […]
FDA issues EUA for LumiraDx point-of-care COVID-19 antigen test
LumiraDx announced today that it received FDA emergency use authorization (EUA) for its LumiraDX SARS-CoV-2 point-of-care antigen test. London-based LumiraDx’s test is designed to detect antigen nucleocapsid protein from a nasal swab and provide results in less than 12 minutes from sample application in symptomatic patients, according to a news release. In clinical studies, the […]
Chembio, Molecule Holdings launch fingerstick COVID-19 tests
Chembio Diagnostics and Molecule Holdings announced the launch of their separate COVID-19 serological point-of-care tests for detecting antibodies associated with coronavirus. Chembio’s fingerstick-style test using its MicroReader 1 and MicroReader 2 analyzers is designed to detect IgM and IgG antibodies and offer results within 15 minutes, according to a news release. Chembio (Medford, N.Y.) said […]
