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LumiraDX

LumiraDx wins CE mark for C-reactive protein test

January 11, 2022 By Sean Whooley

LumiraDx (NSDQ:LMDX) announced today that it received CE mark approval for its C-reactive protein PCR test. London-based LumiraDx designed its LumiraDx CRP test as a small and portable microfluidic immunoassay test used for the quantitative determination of C-reactive protein, delivering results within four minutes. According to a news release, the CRP measurement provides important information […]

Filed Under: Business/Financial News, Diagnostics, Featured, Genomics/Molecular Diagnostics, Regulatory/Compliance Tagged With: CE Mark, LumiraDX

LumiraDx goes public as SPAC deal closes

September 29, 2021 By Chris Newmarker

LumiraDx shares are trading at more than $8 apiece on the Nasdaq today under the symbol LMDX after the company completed its merger with a SPAC called CA Healthcare Acquisition Corp. The point of care diagnostic testing company has a pipeline of more than 30 assays across common health conditions, including infectious diseases, cardiovascular diseases, […]

Filed Under: Business/Financial News, Diagnostics, Digital Health, Featured, Funding Roundup, Initial Public Offering (IPO), Wall Street Beat Tagged With: LumiraDX, SPAC, SPACs

MedTech 100 roundup: Industry roars back

April 12, 2021 By Sean Whooley

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 […]

Filed Under: Business/Financial News, Featured, Funding Roundup, Initial Public Offering (IPO), MassDevice Earnings Roundup, Mergers & Acquisitions, Wall Street Beat Tagged With: Better Therapeutics, Google, Hologic, INSIGHTEC, LumiraDX, MedTech 100 Index, Medtronic, Olympus, Outset Medical, Pixium Vision, Second Sight, Varian

DTW Podcast: Herrera on how military lessons led to Medtech career; Ulmer ready to redo landmark FDA survey

April 9, 2021 By Tom Salemi

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 […]

Filed Under: Device Talks Podcasts, Featured, Regulatory/Compliance, Special Content Tagged With: Boston Scientific, DeviceTalks Weekly, Google, Habit Camera, Hologic, LumiraDX, Spinal Singularity, Ulmer Ventures, Varian

LumiraDx to start trading on Nasdaq through $5B SPAC deal

April 7, 2021 By Sean Whooley

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 […]

Filed Under: Business/Financial News, Diagnostics, Featured, Genomics/Molecular Diagnostics, Mergers & Acquisitions, Wall Street Beat Tagged With: CA Healthcare Acquisition Corp, LumiraDX

LumiraDx warns on false-positives with SARS-CoV-2 antigen test

March 23, 2021 By Sean Whooley

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 […]

Filed Under: Diagnostics, Featured, Genomics/Molecular Diagnostics, Recalls, Regulatory/Compliance Tagged With: coronavirus, COVID-19, LumiraDX, SARS-CoV-2

FDA issues EUA for LumiraDx point-of-care COVID-19 antigen test

August 20, 2020 By Sean Whooley

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 […]

Filed Under: Diagnostics, Featured, Food & Drug Administration (FDA), Genomics/Molecular Diagnostics, Regulatory/Compliance Tagged With: coronavirus, COVID-19, FDA, LumiraDX

Chembio, Molecule Holdings launch fingerstick COVID-19 tests

April 1, 2020 By Sean Whooley

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 […]

Filed Under: Diagnostics, Food & Drug Administration (FDA), Genomics/Molecular Diagnostics, Regulatory/Compliance Tagged With: Chembio Diagnostics, coronavirus, COVID-19, LumiraDX, Molecule Holdings

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May 27, 2022
Quick message - No DTW podcast, but plenty else to listen to over this weekend and next week.
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