MedTech Europe pitches virtual audits to clear MDR coronavirus logjam

The trade group contends technology such as smart glasses and webcams can enable notified bodies to view facilities without having to visit in person.

By Nick Paul Taylor • June 11, 2020

Trump admin encourages return to elective care, with precautions

Major surgeries should still be limited as much as clinically possible among higher risk patients, and facilities should prepare to screen all visitors and staff for symptoms, according to new CMS guidelines.

By Shannon Muchmore • June 10, 2020

Cepheid developing test to distinguish COVID-19 from flu

The company, which plans to pursue the FDA's emergency use authorization pathway for the four-in-one combination test, is aiming to have it ready for next flu season, when a potential spike in coronavirus cases could occur.

By Susan Kelly • June 10, 2020

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

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

BARDA, Evidation team on early detection of COVID-19 using wearables

As part of an agency program to identify people infected with the virus, the company will analyze sleep and activity data, plus self-reported symptoms, aimed at creating an early warning algorithm.

By Nick Paul Taylor • June 5, 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

Pandemic causes expected wearable shipments to plummet by 27M this year

But analysts expect a drawn-out recovery for the sector as wearables bolster their advanced health monitoring features and consumers remain increasingly health-conscious coming out of the COVID-19 crisis.

By Rebecca Pifer • June 4, 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

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

Fitbit, NASA get latest FDA emergency authorizations for ventilators

Fitbit's invention is considered an emergency resuscitator, the same label given to a device manufactured by Boston Scientific. NASA's breathing machine builds on a version of a full-fledged ventilator that gained FDA's OK in April.  

By Nick Paul Taylor • 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

How 3 smaller medtechs are navigating COVID-19

Neuronetics, TransEnterix and CVRx are all specialized device makers seeking to maintain operations and win new customers at a time when medtech sales are disrupted and supplies to help resume them are tough to come by.

By Maria Rachal • June 1, 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

Health systems, ASCs see restart of elective care taking months despite steps to ease patient fears

The biggest worry among providers is the possibility of an outbreak or second wave, followed by low patient demand and inadequate supplies, according to a new survey from consulting firm Deloitte.

By Shannon Muchmore • May 28, 2020

EU group sets path for pre-MDR notified body renewal, coronavirus-era surveillance

A new guidance applies to designating authorities and medical device sector notified bodies whose designations would have expired between this week and the Medical Device Regulation's delayed go-live date next May.

By Maria Rachal • May 28, 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

Analysts saw 30% drop in TAVR growth in April, but Q2 may be better than feared

The Jefferies tracker suggests volume expectations for players in the transcatheter aortic valve replacement market, such as Edwards Lifesciences and Medtronic, may prove a bit conservative.

By Nick Paul Taylor • 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