Diagnostics: Page 33


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    LabCorp inks $150M takeover of Myriad Genetics autoimmune testing unit

    The diagnostics giant discussed its interest in M&A last week, outlining plans to use up to $2 billion in free cash flow to strengthen its businesses through acquisitions.

    By May 4, 2021
  • Siemens Healthineers CLINITEST rapid COVID-19 antigen test
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    Courtesy of Siemens Healthineers
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    Siemens raises outlook as COVID-19 antigen tests blast past original sales target

    The company's bullish prospect for its rapid antigen test business comes as rivals like Abbott Laboratories and Quidel, which are more exposed to the U.S. market, fell short of expectations in the first quarter.

    By May 3, 2021
  • Boston Scientific's Farapulse pulsed field ablation device. Explore the Trendline
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    Trendline

    New medical devices are reshaping the medtech industry

    From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.

    By MedTech Dive staff
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    Illumina sues European Commission to block competition probe into Grail buyout

    The EU probe is the latest glitch in the takeover bid, which was panned by Wall Street and also faces scrutiny from the FTC. Analysts have said Exact Sciences could benefit from delays.

    By April 30, 2021
  • Transmission electron micrograph of a SARS-CoV-2 virus particle, isolated from a patient.
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    National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from Flickr.
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    Hologic, Thermo Fisher cautious on COVID-19 test demand as vaccines roll out

    Hologic CEO Stephen MacMillan told investors late Wednesday demand has fallen significantly since January amid vaccinations. Both companies expect recent M&A to be a crucial part of post-pandemic strategies.

    By April 29, 2021
  • CMS pitches extra year of add-on payments for Boston Scientific, Stryker, other devices

    Boston Scientific's Eluvia drug-eluting stent, Cook Medical's Hemospray and Stryker's SpineJack system are among those that would get the extension under the proposed fiscal 2022 inpatient hospital rule.

    By April 28, 2021
  • Abbott BinaxNOW home COVID-19 test
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    Abbott

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    Abbott, Quest look to post-pandemic home testing beyond COVID-19

    With development of at-home coronavirus tests, the companies see opportunities for over-the-counter and direct-to-consumer diagnostics for other diseases and conditions, from respiratory ailments to cancer.

    By April 27, 2021
  • GE Healthcare grows sales as routine screening, elective procedures return

    The results provide further evidence that the resumption of elective procedures has driven up demand for imaging and other healthcare products and services. GE saw volumes return for cardiac, oncology and neurology screening.

    By April 27, 2021
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    Permission granted by Quidel Corporation
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    Quidel shakes Wall Street with bearish COVID-19 test forecast

    The company late Thursday pre-announced first-quarter revenue nearly $100 million below analyst expectations, with Craig-Hallum's Alex Nowak now calling the business unforecastable.

    By April 23, 2021
  • Transmission electron micrograph of SARS-CoV-2 virus particles, isolated from a patient.
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    National Institute of Allergy and Infectious Disease. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from Flickr.
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    Science groups urge caution against using certain COVID-19 test data

    The Association for Molecular Pathology and the Infectious Diseases Society of America say relying on cycle threshold (Ct) values runs the risk of being misinterpreted due to a lack of standardization across test methods.

    By April 23, 2021
  • Quest Diagnostics building
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    Courtesy of Quest Diagnostics
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    Quest Q1 revenue jumps 49% even as COVID-19 test demand wanes

    CEO Steve Rusckowski told investors Thursday the lab giant's routine business continued its recovery to near pre-pandemic levels, helping offset coronavirus diagnostics coming in below estimates.

    By April 22, 2021
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    Roundup: Medtech earnings show early signs of electives return, lingering testing uncertainty

    The industry is reporting an elective care rebound in March after volumes dropped in the winter, while COVID-19 test demand appears to be softening as vaccination numbers grow.

    April 22, 2021
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    Courtesy of Roche
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    Roche sees strong Q1 sales in COVID-19 tests, routine diagnostics

    Roche Diagnostics CEO Thomas Schinecker predicted second-quarter coronavirus sales would also be healthy, continuing into the third quarter.

    By April 21, 2021
  • Abbott Laboratories
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    Courtesy of Abbott
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    Abbott misses Wall Street as COVID-19 test sales softer than expected

    CEO Robert Ford told investors on Tuesday that $1.8 billion in sales were from its rapid coronavirus testing platforms as he sees a shift to surveillance. But he acknowledged testing is "difficult to forecast right now." 

    By April 20, 2021
  • Trump BIden FOR ALL DIVES
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    Photography by Gage Skidmore / Photo Illustration by Kendall Davis/MedTech Dive
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    FDA scraps Trump-era 510(k) exemption bid in scathing dissection of 'flawed' plan

    The agency nixed the proposal, which HHS made without consulting FDA, after strong pushback from Baxter and digital health startups, among other stakeholders, as well as its own staff.

    By April 16, 2021
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    Elizabeth Regan/MedTech Dive
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    Thermo Fisher to buy research contractor PPD for $17.4B

    The deal comes months after a failed attempt by the company to acquire molecular diagnostics company Qiagen. 

    By Kristin Jensen • April 15, 2021
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    Adeline Kon/Healthcare Dive/MedTech Dive
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    6 medtechs to watch when earnings kick off next week

    First quarter results from Abbott, Edwards, Intuitive, J&J, Quest and Roche will help reveal the pace of procedure recovery and if the coronavirus testing boom has legs despite the rollout of vaccines. 

    By April 15, 2021
  • Mid-sized medtechs hit hardest by pandemic, though sector seen resilient: poll

    The survey of more than 1,600 industry professionals from Emergo by UL also found respondents are most bullish on tapping Asian markets.

    By April 14, 2021
  • Transmission electron micrograph of SARS-CoV-2 virus particles, isolated from a patient.
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    National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
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    Lucira gets FDA nod for OTC molecular COVID-19 test

    The emergency authorization adds to the competition with the agency clearing over-the-counter tests from Abbott and Cue Health in recent months. The $55 per kit price tag is much higher than Lucira's estimate earlier this year.

    By April 13, 2021
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    Medtronic launches AI-based colonoscopy device in US on heels of FDA clearance

    The medtech is the exclusive global distributor of Cosmo Pharmaceutical's GI Genius module, which has been granted De Novo clearance and is compatible with colonoscope video for identifying polyps and lesions. 

    By April 12, 2021
  • Italy's DiaSorin buys Luminex in $1.8B deal for multiplex molecular testing assets

    The takeover comes weeks after Roche agreed to pay $1.8 billion to buy GenMark Diagnostics for its multiplex testing capabilities. The two targets compete with BioFire and Quidel.

    By April 12, 2021
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    Adobe Stock
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    Hologic pens $795M Mobidiag buyout to expand in acute care testing

    Wall Street analysts cheered the move, with Evercore ISI writing "it fills a major hole in the company's armament." The deal marks Hologic's fourth pick-up of 2021, including the $230 million takeover of Biotheranostics in January.

    By April 9, 2021
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    Nasdaq
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    LumiraDx lands on Nasdaq via SPAC with aim to undercut Abbott on price

    The COVID-19 test maker hopes to generate enough capital to pursue a point-of-care testing opportunity it values at $76 billion. It has a ways to go to deliver.

    By April 8, 2021
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    Permission granted by IQVIA
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    FDA-medtech consortium offers strategy to boost patient engagement in clinical trials

    The MDIC report, created by a working group including Exact Sciences and J&J, follows the agency's late 2019 draft guidance meant to increase the influence of patients in medical device clinical trial design. 

    By April 7, 2021
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    Fewer heart tests ordered for telehealth patients in pandemic

    Research published in JAMA Network Open also found those using the virtual services were more likely to be Asian, Black or Hispanic.

    By April 6, 2021
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    Getty / Edited by BioPharma Dive
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    Invitae inks $200M Genosity buyout, lands $1.2B investment to expand genetic testing

    The medical genetics company expects Genosity's capabilities to increase access to its cancer test and reduce turnaround time, while a sizable investment led by SoftBank will support growth initiatives.

    By April 6, 2021