Diagnostics: Page 32
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Grail starts selling multi-cancer liquid biopsy Galleri in the US
The move comes as regulators scrutinize a $7.1 billion buyout bid by Illumina. Grail will face the challenge of getting insurers' support while competing with Guardant Health, Exact Sciences and Freenome.
By Nick Paul Taylor • June 7, 2021 -
Jacob Bell/MedTech Dive
Cognoa's machine learning software for autism diagnosis gets FDA nod
The software as a medical device, which uses an algorithm, reports a positive or negative diagnosis based on analyses of videos of the child and other information. The product got FDA's breakthrough designation in early 2019.
By Nick Paul Taylor • June 3, 2021 -
Explore the Trendline➔
Permission granted by Boston Scientific
TrendlineNew 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 -
Abbott
Abbott's COVID-19 testing surprise suggests demand softening faster than sector forecast
The medtech on Tuesday cut its 2021 outlook blaming a sharp, rapid decline in demand for its coronavirus-related tests on vaccinations. The sudden hit to test volumes could be a harbinger for the diagnostics sector.
By Greg Slabodkin • June 2, 2021 -
Courtesy of Abbott
Abbott cuts 2021 outlook, blaming rapid decline in COVID-19 testing demand
CEO Robert Ford described a "sharp and rapid" drop-off in demand, a trend the company expects to continue. Shares slumped 7% on the news.
By Greg Slabodkin • June 1, 2021 -
ACLA appeals dismissal of PAMA lawsuit, pushes legislative fixes
The lab trade group for Quest, LabCorp and others argues the Protecting Access to Medicare Act is a case of "harmful regulatory overreach" that forces an "unsustainable reimbursement model" on its members.
By Nick Paul Taylor • June 1, 2021 -
Courtesy of Abbott, PRNewswire
HHS commits $4.8B to COVID-19 testing for the uninsured
The American Clinical Laboratory Association, with members including LabCorp and Quest Diagnostics, had urged the Biden administration in February to make more money available.
By Susan Kelly • May 26, 2021 -
MDR challenges remain as regulation goes into effect: MedTech Europe
The European trade group contends that while the Medical Device Regulation's May 26 effective date marks a significant milestone, hurdles limit industry’s ability to "seamlessly supply certified devices under the new rules."
By Greg Slabodkin • May 26, 2021 -
Courtesy of Quest Diagnostics
Quest partners with Paige to create AI-enabled cancer pathology products
The two will initially focus on developing regulatory-approved products that support the diagnosis of solid tumors such as cancers of the prostate, breast, colorectal region and lung.
By Nick Paul Taylor • May 26, 2021 -
MDR is live. Here are 5 things to know on where the rule stands.
The device industry has resolved some near term pressures as the EU's delayed landmark regulation comes into effect, but challenges related to IVDR, Brexit and more remain.
By Nick Paul Taylor • May 25, 2021 -
Courtesy of Quest Diagnostics
Labs urge HHS to back new regulatory regime for diagnostic tests
The trade group for Quest, LabCorp and others wants the Biden administration to back legislation to create a framework for laboratory developed tests separate from medical devices.
By Susan Kelly • May 24, 2021 -
FDA 'working around the clock' with COVID-19 workload, all reviews impacted: CDRH chief
Jeff Shuren said Wednesday the agency might miss some Medical Device User Fee Amendments performance goals for PMA applications and 510(k) submissions.
By Greg Slabodkin • May 20, 2021 -
Sean Gallup via Getty Images
FDA opposes COVID-19 antibody testing to assess post-vaccination immunity
The warning comes as some medtechs bet on the tests. Beckman Coulter unveiled a fully quantitative one just as the agency issued the safety notice.
By Nick Paul Taylor • May 20, 2021 -
OrbiMed, RA Capital top healthcare investors in Q1: CB Insights
OrbiMed topped the list in part because of the investment firm's activity in the medtech industry, where it put money into companies including AnchorDx, Noctrix Health and Adicon.
By Nick Paul Taylor • May 19, 2021 -
Courtesy of Exact Sciences
US panel trims colorectal cancer screening age, opens door to annual Cologuard use
William Blair said the recommendations are a positive for Exact Sciences, which has framed the guidance as a chance to drive growth by targeting 19 million people in the screening cohort.
By Nick Paul Taylor • May 19, 2021 -
Adeline Kon/Healthcare Dive/MedTech Dive
PerkinElmer inks $155M Immunodiagnostic buyout, continuing deal spree
The flurry of M&A means PerkinElmer has struck more deals, at a higher aggregate value, in the first six months of 2021 than in the years since it bought Euroimmun for $1.3 billion in 2017.
By Nick Paul Taylor • May 18, 2021 -
Cue raises $235M to build on point-of-care COVID-19 testing
Updates from Abbott and Quidel suggest the U.S. market for rapid COVID-19 tests has softened in recent months, but the San Diego startup still expanded its investor syndicate to raise its biggest financing round yet.
By Nick Paul Taylor • May 14, 2021 -
Nathan Howard via Getty Images
Thermo Fisher, Quest step up K-12 COVID-19 testing as school districts look to safely reopen
Color Health and Thermo Fisher are providing tests to students, teachers and staff as part of a screening pilot in Ohio, while Quest has teamed up with Ginkgo Bioworks to offer pooled testing to schools across the U.S.
By Nick Paul Taylor • May 13, 2021 -
Stefani Reynolds / Stringer via Getty Images
Lawmakers, industry urge CMS to push breakthrough payment rule as May 15 deadline looms
Amid speculation of another delay, Democrats in Congress wrote to acting CMS administrator Liz Richter voicing support for the Medicare Coverage for Innovative Technology rule.
By Nick Paul Taylor • May 13, 2021 -
Lintao Zhang / Staff via Getty Images
EU plans to impose additional regulations on medtech AI products, other 'high-risk' systems
The proposed legal framework, which addresses potential artificial intelligence risks, seeks to regulate the technology and issue fines for noncompliance that could total billions of dollars, positioning Europe for a leading AI role globally.
By Nick Paul Taylor • May 12, 2021 -
Alex Wong via Getty Images
CMS implementation of breakthrough payment rule may be further delayed: Cowen
The agency will most likely push the start date back further to address the concerns of critics of the contentious Medicare Coverage of Innovative Technology initiative, an analyst contends.
By Nick Paul Taylor • May 10, 2021 -
Permission granted by Quidel Corporation
Quidel says COVID-19 testing 'not forecastable' as it targets alternative, at-home markets
CEO Doug Bryant on Thursday's first-quarter earnings call said the company sees increasing revenue opportunities tied to at-home, back-to-school and back-to-work tests but "it's impossible for us to model at this stage."
By Greg Slabodkin • May 7, 2021 -
Mario Tama via Getty Images
NeoGenomics inks $390M Inivata buyout to enter liquid biopsy space
William Blair analysts wrote that NeoGenomics got a good price by setting the buyout fee last year.
By Nick Paul Taylor • May 6, 2021 -
Courtesy of BD/PRNewswire
BD grows Q2 revenue despite COVID-19 test dip, spins off diabetes business
The spin off for the separate publicly traded company is expected to be completed in the first half of calendar year 2022. The move will not impact BD's ability to fulfill orders related to COVID-19 vaccinations, execs said.
By Greg Slabodkin • May 6, 2021 -
Sarah Silbiger via Getty Images
AI, digital health feature in latest batch of FDA breakthrough device designations
The agency granted regulatory privileges to artificial intelligence products, including software designed to enable the early detection of cancer and technology to help surgeons tell if cancer is still present after surgical excision.
By Nick Paul Taylor • May 5, 2021 -
Courtesy of Qiagen
Qiagen braces for COVID-19 testing volatility as sales hold steady in Q1
Coronavirus-related revenues were flat sequentially, helping the company to grow above its outlook. However, the consistency masks changes in where tests are in demand with region-to-region variability expected to continue.
By Nick Paul Taylor • May 4, 2021
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