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Search Results for: point-of-care

Cue Health raises $235M to support its over-the-counter, home-use diagnostics

May 14, 2021 By Sean Whooley

Healthcare technology company Cue Health announced that it closed a private financing round worth $235 million. Existing investors Johnson & Johnson Innovation — JJDC, Decheng Capital, CAVU Ventures, ACME Capital and more contributed to the financing, as did new investors Perceptive Advisors, MSD Capital and Koch Strategic Platforms, according to a news release. Morgan Stanley […]

Filed Under: Business/Financial News, Diagnostics, Digital Health, Featured, Funding Roundup, Genomics/Molecular Diagnostics, Health Technology Tagged With: coronavirus, COVID-19, Cue Health

Abbott sees a future for at-home diagnostics after COVID-19

April 27, 2021 By Sean Whooley

Abbott CEO Robert B. Ford has suggested that at-home diagnostics could be here to stay even after the COVID-19 pandemic. Speaking on Abbott’s April 20 earnings call, transcribed by SeekingAlpha, Ford pointed out that the company’s diagnostics sales increased by 115% year-over-year from the first quarter of 2020, with a significant chunk of that made […]

Filed Under: Business/Financial News, Diagnostics, Featured, Genomics/Molecular Diagnostics Tagged With: Abbott, coronavirus, COVID-19

FDA issues EUA for single-use, OTC PCR COVID-19 at-home test

April 12, 2021 By Sean Whooley

Lucira Health announced today that it received FDA emergency use authorization (EUA) for over-the-counter sales of its COVID-19 test kit. Emeryville, Calif.-based Lucira’s PCR molecular test kit, the Lucira Check It kit, is designed to deliver results in 30 minutes or less at home. The authorization covers those with symptoms and those without, and the […]

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

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

Inflammatix raises $102M

April 1, 2021 By Sean Whooley

Inflammatix announced last month that it closed a $102 million Series D financing round to support its diagnostics portfolio. Burlingame, Calif.-based Inflammatix develops a molecular diagnostic designed to read the patient’s immune system to deliver rapid results, with an initial focus on acute infection and sepsis. Its HostDx tests combine proprietary biomarkers and advanced machine […]

Filed Under: Business/Financial News, Diagnostics, Funding Roundup, Genomics/Molecular Diagnostics Tagged With: Inflammatix

FDA authorizes use of over-the-counter COVID-19 tests for screening

April 1, 2021 By Sean Whooley

The FDA announced today that it authorized several COVID-19 tests for over-the-counter use in asymptomatic screening. Among the tests authorized were the BinaxNow Ag card from Abbott (which includes point-of-care screening) and the Quidel Quick-View at-home test. FDA also authorized the BD Veritor Plus system for POC screening with a prescription. “BD is supporting the […]

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

BD lands EUA for COVID/flu test

March 29, 2021 By Sean Whooley

The FDA issued a letter to BD (NYSE:BDX) to confirm the emergency use authorization of its Veritor system for detecting COVID-19 and flu. According to the letter, dated last week, the Veritor system was authorized for the simultaneous qualitative detection and differentiation of SARS-CoV-2 nucleocapsid antigen and/or influenza A and B nucleoprotein antigens directly from […]

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

BrainScope launches next-gen concussion diagnostic device

March 25, 2021 By Sean Whooley

BrainScope announced that it launched its third FDA-cleared algorithm for concussion diagnosis on the BrainScope device. Bethesda, Md.–based BrainScope’s Concussion Index is the first physiological marker of concussive injury that aids clinicians in the assessment of patients at baseline, point of injury and through recovery, according to a news release. The index adds to BrainScope’s […]

Filed Under: Business/Financial News, Featured, Health Technology, Neurological, Software / IT Tagged With: BrainScope

Calumeo launches dry-heat N95 reprocessor

March 15, 2021 By Nancy Crotti

Calumeo today announced the U.S. launch of a point-of-care N95 mask reprocessing device. The Morgan Hill-Calif.-based company said its Calumeo Clean countertop device uses dry heat to decontaminate N95 masks for reuse, without the use of toxic chemicals. The process takes just over an hour. The device can process six masks at a time and each […]

Filed Under: Business/Financial News, Food & Drug Administration (FDA), Respiratory, Sterilization / Calibration Tagged With: Calumeo, coronavirus, COVID-19, N95, PPE

BD partners with ImageMover for COVID-19 test mobile app

March 9, 2021 By Sean Whooley

Becton Dickinson (NYSE:BDX) announced today that it entered into an agreement with ImageMover to offer a mobile app for COVID-19 testing. Franklin Lakes, N.J.-based Becton Dickinson’s agreement enables the ImageMover software platform to simplify medical data collection and management through a companion mobile app for SARS-CoV-2 antigen testing performed on the BD Veritor Plus system, […]

Filed Under: Big Data, Business/Financial News, Diagnostics, Digital Health, Electronic Medical Records (EMR), Featured, Genomics/Molecular Diagnostics, Health Technology, Software / IT Tagged With: BD, becton dickinson, coronavirus, COVID-19, ImageMover

Philips, DiA partner on AI-based applications for ultrasound

March 2, 2021 By Chris Newmarker

Philips (NYSE: PHG, AEX: PHIA) announced today that it has formed a strategic partnership with DiA Imaging Analysis to incorporate DiA’s AI library of automated solutions with Philips ultrasound. Be’er Sheva, Israel–based DiA’s AI-enabled 2D ultrasound applications have FDA clearance and a CE Mark. The applications are geared toward reducing variability and increasing the efficiency […]

Filed Under: Business/Financial News, Health Technology, Imaging, Software / IT, Ultrasound Tagged With: AI, artificial intelligence, DiA Imaging Analysis, Philips

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