DOJ charges medtech exec with $69M in COVID-19 test fraud, notes Theranos parallel

The Department of Justice said the case against an Arrayit Corporation exec is the first criminal securities fraud prosecution in relation to the pandemic.

By Nick Paul Taylor • June 10, 2020

Ex-FDA chief scientist slams 'chaos' caused by agency approach to antibody tests

Jesse Goodman said the agency’s decision to allow developers of COVID-19 serology tests to self-validate their products led unqualified entities to flood the market.

By Nick Paul Taylor • June 10, 2020

Explore the Trendline➔

Medical device industry continues to turn to AI

While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.

By MedTech Dive staff

Siemens Healthineers, Geisinger ink 10-year digital health partnership

It's one of the medtech's largest partnerships of its kind in North America, as it plans to provide diagnostic imaging and artificial intelligence-enabled applications to the health system over the next decade.

By Greg Slabodkin • June 9, 2020

FDA expands at-home, saliva-based coronavirus testing with nod to Phosphorus

Individuals can obtain a test kit from the genomics startup without using an outside telemedicine platform.

By Nick Paul Taylor • June 9, 2020

Lawmakers push HHS to funnel funds to clinical labs amid routine testing decline

Members of Congress on both sides of the aisle argue the investments laboratories are making to scale up COVID-19 testing mean they need more targeted financial support, which should come out of a $25 billion relief fund.

By Nick Paul Taylor • June 9, 2020

COVID-19 false negatives fuel call for urgent focus on asymptomatic patients

Harvard and Yale physicians writing in the New England Journal of Medicine called for development of a reference standard for measuring sensitivity of coronavirus tests in those without symptoms who may infect others.

By Nick Paul Taylor • June 8, 2020

Healthcare sector adds 312K jobs in May, but hospitals left out

A collective uptick of roughly 124,000 jobs in health professional and physician offices suggests patients who have been delaying non-urgent medical care are back and seeking treatment outside hospitals. 

By Hailey Mensik • Updated June 8, 2020

FDA warns of cyanide gas risk with certain media if used with Hologic coronavirus test

The agency alerted clinical labs and healthcare providers to the potential for bleach to react with guanidine materials and produce deadly gas, making it unsafe to use some transport media with Hologic’s assays.

By Nick Paul Taylor • June 5, 2020

Months into pandemic, Trump admin mandates labs report demographic data of COVID-19 tests

HHS is now requiring labs to submit a much broader range of data related to testing. However, the American Clinical Laboratory Association said it's difficult for labs to get information to public health agencies without help from providers.

By Rebecca Pifer • June 4, 2020

European Commission lays out timeline for next steps toward MDR, IVDR

Targets for issuing upcoming implementing acts, including those on reprocessing single-use medical devices and the delayed Eudamed database, range from the coming quarter to two years from now.

By Nick Paul Taylor • June 4, 2020

PMA major deficiency letters tick up, 510(k) asks for info flatline: MDUFA report

FDA's second quarter report for fiscal 2020, which covered January through March, also showed that the agency still has many guidance document priorities to check off its list.

By Maria Rachal • June 4, 2020

Governors plead for Trump admin to streamline swab, reagent distribution

"We're competing against other states and sometimes our own federal government," Colorado Gov. Jared Polis, a Democrat, told a House subcommittee Tuesday of challenges procuring COVID-19 testing supplies.

By Rebecca Pifer • June 3, 2020

US needs 10-fold increase in COVID-19 testing, analysts say

Jefferies' analysis predicts such an uptick could give test suppliers including Abbott, Hologic and Thermo Fisher a collective $16 billion boost, while LabCorp and Quest Diagnostics may share in a $50 billion tailwind.

By Nick Paul Taylor • June 2, 2020

Tests to detect cancer, guide treatment heat up with barrage of data at ASCO

Exact Sciences, Guardant Health and Oncocyte were among the companies to share data on products targeting breast and lung cancers.

By Nick Paul Taylor • June 1, 2020

At-home COVID-19 test kits set to climb as Quest, LetsGetChecked get FDA nods

Direct-to-consumer startup LetsGetChecked currently has capacity for 300,000 of the self-collection products per week. Quest hasn't yet launched its offering but said more than 500,000 of its sampling kits will be available by end of June.

By Maria Rachal • May 29, 2020

Widespread shortages for COVID-19 test materials persist, poll says

The survey by the Association for Molecular Pathology also found Abbott and Roche make the first-choice assays in 16% and 17% of centers, respectively — the most popular after in-house diagnostics with EUAs.

By Nick Paul Taylor • May 29, 2020

Emergency authorization granted to COVID-19 ICU prediction software

The FDA nod for CLEW Medical's system is among a series of regulatory OKs for products designed to inform care for infected patients.

By Nick Paul Taylor • May 28, 2020

FDA offers reference panel to validate coronavirus tests amid false negatives

The aim is to aid commercial and lab developers in ensuring diagnostic testing quality with independent performance validation. Recent studies flagged double-digit rates of false negatives among such tests.

By Nick Paul Taylor • May 28, 2020

FDA Breakthrough Devices Program nears 300 designations

The agency has tapped 50 devices so far this year, with recent nods to Orteq, Thermedical, ArcherDX, Helius, PhotoPharmics and Terumo.

By Susan Kelly • May 27, 2020

CDC seeks to limit false positives with COVID-19 antibody testing, as immunity question lingers

The interim guidelines promote using high-specificity assays and conducting confirmatory tests when appropriate. However, the agency won't yet use serologic test results to sway public health recommendations.

By Nick Paul Taylor • May 27, 2020

Abbott, Roche ink deals with UK for 10M coronavirus antibody tests

The notice from the government, which bought $20 million in unreliable antibody tests early in the crisis, came as FDA removed 28 products from a list of the tests that can be used without emergency use authorizations.

By Nick Paul Taylor • May 22, 2020

Hospitals push FEMA to form broad supply pact with medtech

The agency on Thursday is set to discuss a proposed five-year voluntary agreement with industry to better distribute medical products, which health systems hope will go beyond personal protective equipment.

By Nick Paul Taylor • Updated May 26, 2020

Labs welcome CMS rate for coronavirus antibody testing

Analysts at William Blair said the roughly $42 rate for common serological tests is higher than expected, which may bode well for antigen testing reimbursement.

By Nick Paul Taylor • May 20, 2020

Coronavirus pushes Mayo Clinic's operating income into free fall

Operating income plunged 88% by the end of the first quarter due to the pandemic and the near closure of the health system's outpatient business. Still, Mayo has become a leader in COVID-19 testing. 

By Samantha Liss • May 19, 2020

Philips lung ultrasound, Beckman sepsis diagnostic receive BARDA coronavirus backing

The separate projects aim to incorporate machine learning algorithms to enhance technologies meant to support COVID-19 patients.

By Susan Kelly • May 19, 2020