Diagnostics

Fitbit data suggests potential for early COVID-19 detection using wearables

While the algorithm would generate far more false than true positives even when prevalence is high, researchers argue it could encourage more testing and precautions. The results have yet to be validated in a prospective study.

By Nick Paul Taylor • Dec. 01, 2020

Grail inks commercial pact with UK government for multi-cancer blood test

As competition mounts among liquid biopsy developers, the agreement gives Illumina target Grail the chance to validate its early detection tool in the real world and potentially secure access to the broader U.K. market.

By Nick Paul Taylor • Nov. 30, 2020

IVDR notified body count inches up to 5 with TÜV Rheinland designation

The medtech notified bodies trade group urged swift action on potentially delaying the start date for the In Vitro Diagnostic Regulation if designations don't more than double by year's end.

By Nick Paul Taylor • UPDATED: Nov. 30, 2020 at 11:07 a.m.

Hospitals adopt new round of elective surgery restrictions, brace for Thanksgiving COVID-19 surge

The American College of Surgeons is among those placing new emphasis on factoring healthcare worker wellbeing into capacity decisions.

By Maria Rachal • Nov. 25, 2020

Breast cancer tech among FDA's latest breakthrough nods

Over the past month, designations for speedier review have also ranged from a migraine treatment to tissue regeneration tech for spinal cord injuries.

By Susan Kelly • Nov. 24, 2020

MedTech Europe backs proposed EU Health Union but flags potential hangups

The trade group fears moving responsibility for administering the IVDR and MDR expert panels to the European Medicines Agency could slow deployment.

By Nick Paul Taylor • Nov. 20, 2020

Notified bodies report early success with remote audits but challenges remain

While there have been benefits to going remote during the pandemic, 57% of those polled by a European trade group say they take longer than on-site assessments and most encounter problems due to poor network connections.

By Nick Paul Taylor • Nov. 20, 2020

HHS piloting Cue's NBA-tested rapid COVID-19 diagnostic in 5 states

Unlike lab-based molecular tests, which can take two to three days to turn around, Cue Health's point-of-care molecular test generates results in about 20 minutes.

By Maria Rachal • Nov. 19, 2020

Health insurers, labs point fingers over COVID-19 test coverage and prices

An AHIP study of claims data is the latest volley in a debate about who ultimately foots the bill for coronavirus diagnostics. ACLA blames "murky" tri-agency guidance for coverage denials and high out-of-pocket costs. 

By Nick Paul Taylor , Greg Slabodkin • Nov. 19, 2020

FDA OKs first fully at-网络百家家乐真人视频home COVID-19 test as US cases surge

An emergency use ization to biotech Lucira Health comes as some experts say the tests could help significantly boost capacity. Others say that's a long way off, and call for more guidance from regulators on proper use.

By Greg Slabodkin • Nov. 18, 2020

In shift, FDA ordered to provide 'timely' EUA reviews for COVID-19 lab developed tests

Testing czar Brett Giroir has reversed FDA's decision to no longer review emergency use ization requests for LDTs so that university labs can secure EUAs and get liability protection under the PREP Act.

By Greg Slabodkin • Nov. 17, 2020

EU regulators provide 7 rules for classifying diagnostics under IVDR

The European Commission's Medical Device Coordination Group placed IVDs into different risk categories based on how they will be used. Only one class can be self-certified.

By Nick Paul Taylor • Nov. 16, 2020

Labs face COVID-19 surges, warn of test result delays as CMS pay cuts loom

The American Clinical Laboratory Association sounded an alarm over nationwide capacity constraints, which may increase average time to results.

By Maria Rachal • Nov. 13, 2020

Quidel on defense after COVID-19 vaccine spurs questions of reduced testing demand

The company's stock has been under pressure following positive vaccine results. CEO Doug Bryant argued Thursday the demand for tests is "endless."

By Greg Slabodkin • Nov. 13, 2020

3 ways Biden's COVID-19 approach could impact medtech

A new administration — regardless of who's in power — means device makers can anticipate shifts at key government agencies like the FDA.

By Maria Rachal , Greg Slabodkin • Nov. 12, 2020

Qiagen seeks EUA for COVID-19 antigen test aiming for positive results in 2 minutes

The company claims 90% sensitivity, whereas other antigen tests sold by Abbott, Roche and Quidel have reported sensitivities of around 97%.

By Nick Paul Taylor • Nov. 12, 2020

Remote trials, US-Israel device partnership among pitches in FDA, HHS funding bills

The Senate appropriations committee released a series of budget proposals for fiscal 2021. FDA's device center is slated for a 5% funding increase, making it one of the only centers set to receive less than requested.

By Nick Paul Taylor • Nov. 11, 2020

UK fleshes out post-Brexit approach to regional medical device marking

The Medicines and Healthcare products Regulatory Agency further clarified conformity marking as medtechs prepare for the transition period to end.

By Nick Paul Taylor • Nov. 11, 2020

Abbott COVID-19 tests at center of squabble between Trump administration, states

HHS testing czar Brett Giroir on Monday said the government is halting the antigen test shipments to eight states until those already sent are distributed and used. At least one state pushed back on his assertions.

By Greg Slabodkin • Nov. 10, 2020

Quidel, Hologic, other test stocks sink as vaccine result brings hope for pandemic's end

The declines Monday, led by a 28% drop at Quidel, reflect concerns that availability of an effective COVID-19 vaccine will tamp down on the multibillion-dollar testing boom.

By Nick Paul Taylor • Nov. 10, 2020

What Intuitive is looking for through its new $100M venture fund

Surgical robots have been Intuitive's sweet spot. As the company moves into VC for the first time, its broader focus on minimally invasive care, including interest in digital tools and precision diagnostics, opens more opportunities.

By Maria Rachal • Nov. 09, 2020

Biden transition team names COVID-19 advisers, seeks dramatic testing scale-up with federal approach

The president-elect calls for doubling drive-through test sites and increasing capacity by "orders of magnitude" through investing in rapid at-网络百家家乐真人视频home tests. The transition team has already called in help from former FDA and BARDA heads.

By Greg Slabodkin • Nov. 09, 2020

GenScript wins 1st FDA nod to test for antibodies that could neutralize COVID-19

The Hong Kong-listed biotech's offering differs from earlier EUAs for serology tests from Abbott, Roche and Siemens Healthineers that only screen for antibodies that do not necessarily cut viral infection.

By Susan Kelly • Nov. 09, 2020

Guardant beats expectations but warns COVID-19 surges will hurt Q4 growth

On a more optimistic note, the blood test developer expects the recent FDA approval for its Guardant360 tumor profiling liquid biopsy will increase its CMS payment rate and expand reimbursement among private payers.

By Nick Paul Taylor • Nov. 06, 2020

Patients shirked diagnostic testing, in-person preventive care amid telehealth boom this spring

Routine preventive services that can't be done virtually, such as mammograms and colonoscopies, plunged 65% in March and April compared to the year prior, according to an analysis published in JAMA Network Open.

By Hailey Mensik • Nov. 05, 2020