Diagnostics: Page 3

Abbott's Panbio antigen test misses half of asymptomatic COVID-19 cases in Irish study

The finding led Ireland to recommend against using single, standalone antigen kits for the purposes of such screening.

By Nick Paul Taylor • June 15, 2021

FDA rejects Verily filing for wrist-worn Parkinson's clinical trial device

The sister company of Google developed the feature to collect data on the motor function of Parkinson's patients in between visits to trial sites. However, the agency questioned the wearable's ability to have a meaningful effect. 

By Nick Paul Taylor • June 14, 2021

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How medtechs are navigating the sales environment through the pandemic

The impact of the pandemic on the industry was far from even, given the diversity of companies in the space — from those that make heart valves to artificial hips and knees to robotics to point of care testing.

By MedTech Dive staff

FDA blasts Innova for shipping unapproved COVID-19 test, using false or misleading labeling

The agency hit the California-based medtech with a flurry of actions on Thursday, firing off a warning letter alongside notice of a Class I recall and a press release telling the public to stop using the antigen test. 

By Nick Paul Taylor • UPDATED: June 11, 2021 at 11:43 a.m.

HHS warns providers, insurers COVID-19 testing must be free for patients

The American Clinical Laboratory Association, which includes Quest Diagnostics and LabCorp, has complained that guidance on the topic had only served to muddy what they saw as clear congressional mandates.

By Greg Slabodkin • June 10, 2021

EU provides plan to meet 'serious challenge' of readiness for IVDR

The document by the Medical Device Coordination Group is designed to ensure "limited resources" are focused on the activities that are critical to being ready by May 2022.

By Nick Paul Taylor • June 10, 2021

Amazon offers COVID-19 test online to consumers with a website for viewing results

The tech giant's coronavirus diagnostic, which received FDA emergency authorization in March, was originally designed for use by company employees but is now available for $39.99 to the public.

By Nick Paul Taylor • UPDATED: June 16, 2021 at 10:43 a.m.

BD doubles down on COVID-19 testing outlook, despite Abbott warning about demand drop-off

CEO Tom Polen told investors the company stands by its guidance for the rest of the year of $1.8 billion to $1.9 billion in revenue for coronavirus diagnostics, regardless of "anything our competitors have announced."

By Greg Slabodkin • June 08, 2021

OraSure gets EUAs to enter shrinking COVID-19 antigen test market

The technology is differentiated from other rapid antigen tests but is coming to market amid what Abbott characterized as a "sharp and rapid" drop in demand.

By Nick Paul Taylor • June 08, 2021

Cancer tech dominates FDA's latest batch of breakthrough devices

The agency's recent breakthrough designations feature a clutch of oncology devices and diagnostics from companies including Viome and Avenda Health.

By Nick Paul Taylor • June 07, 2021

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 07, 2021

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 03, 2021

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 02, 2021

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 01, 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 01, 2021

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

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

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

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

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

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