Medical machine-learning studies lack high-quality clinical trials, review shows

The findings “highlight areas of concern regarding the quality of medical machine learning RCTs and suggest opportunities to improve reporting.”

By Nick Paul Taylor • Oct. 4, 2022

Illumina ushers in $200 genome with the launch of new sequencers

The company’s machines are part of a long line of products that have enabled Illumina to dominate the market for short-read sequencing.

By Nick Paul Taylor • Oct. 3, 2022

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

Digital pathology gains momentum among US providers, vendors: report

Already popular in Europe, digital pathology technologies are primed for growth in the U.S., according to a report from KLAS research.

By Hailey Mensik • Sept. 30, 2022

FDA switches COVID-19 tests to De Novo, 510(k) pathways, limiting EUAs

The FDA will still review EUA requests from “experienced developers” of tests that meet certain criteria.

By Nick Paul Taylor • Sept. 28, 2022

BD launches research-use monkeypox test, plans EUA filing for clinical use

The rollout of the assay could benefit from the BD MAX machines that laboratories installed to test for SARS-CoV-2, according to the company.

By Nick Paul Taylor • Sept. 27, 2022

Hospital procedures have remained steady since H2 in boost for medtechs, survey finds

Evercore ISI analysts said the findings bode well for device companies, even as hospitals expect capital spending to drop next year.

By Elise Reuter • Sept. 26, 2022

Puerto Rico-based lab ceases COVID-19 test; FDA revokes EUA

The FDA disclosed the action alongside updates to the instructions for use for Thermo Fisher Scientific’s TaqPath COVID-19 test.

By Nick Paul Taylor • Sept. 26, 2022

Forget oximeters, smartphone cameras detect 79% of cases of low blood oxygen in small study

If the results are validated by wider studies, physicians will have a new tool to increase the number of people who can be monitored for chronic and acute respiratory conditions. 

By Nick Paul Taylor • Sept. 23, 2022

Watchdog faults FDA for rushing COVID-19 tests to market by easing emergency use rules

HHS’ Office of Inspector General found that by loosening emergency use authorization requirements to bring COVID-19 tests to market faster, the agency allowed inaccurate tests to be distributed.

By Elise Reuter • Sept. 21, 2022

Racial bias in pulse oximeters to be subject of FDA panel

The design of the ubiquitous fingertip monitors has inadvertently caused false blood oxygen readings in darker-skinned patients, a problem the FDA hopes to fix.

By Peter Green • Sept. 16, 2022

FDA eases authorization policy for monkeypox tests as lab group points to ‘lessons learned’ from Covid-19

Laboratory group says new agency guidance that offers templates and more time to submit data should help test developers.

By Elise Reuter • Sept. 15, 2022

Medtech firms increasingly positive about future as staffing, inflation pressures ease, say RBC analysts

Hospital staffing and supply chain issues are expected to improve, according to comments from Boston Scientific, J&J, Medtronic, and others.

By Nick Paul Taylor • Sept. 15, 2022

Amid merger turmoil, Illumina’s Grail unit reports downturn in accuracy of blood-based cancer test

New data on Grail’s cancer screening test could weaken the company’s competitive standing against rivals Guardant Health, Exact Sciences and Freenome.

By Nick Paul Taylor • Sept. 12, 2022

Friday Q&A: BD Life Sciences President Dave Hickey shares plans for expanded testing ‘menu’

Demand for COVID-19 tests may be slowing, but more laboratories have installed testing systems during the pandemic, the executive says.

By Elise Reuter • Sept. 8, 2022

FDA issues first EUA for monkeypox test

Quest Diagnostics' PCR test for monkeypox received emergency use authorization after the FDA issued guidance on how it will evaluate the tests.

By Elise Reuter • Sept. 8, 2022

HHS will allow EUAs for monkeypox tests to increase access in the US

The move follows the declaration of a public health emergency for the monkeypox outbreak on Aug. 4.

By Ricky Zipp • Sept. 7, 2022

Illumina’s hold on Grail depends now on separate appeals in US, Europe

Even as it plans to appeal a European Commission decision and the FTC plans to appeal a U.S. ruling, Illumina say it’s preparing for ‘strategic alternatives’ to its acquisition of early cancer detection firm Grail.

By Elise Reuter • Updated Sept. 7, 2022

Federal jury convicts medtech executive in $77M blood testing kickback case

Arrayit President Mark Schena’s conviction on nine federal charges carries a maximum sentence of more than 100 years in prison.

By Nick Paul Taylor • Sept. 6, 2022

Machine learning algorithm predicts unfavorable labor outcomes for mothers in retrospective study

The researchers plan to validate the model using Mayo Clinic patients before deploying it prospectively in maternity wards.

By Nick Paul Taylor • Sept. 6, 2022

Another COVID-19 test supplier ordered by FDA to take its products off the market

USA Medical has been warned by FDA that its rapid antigen tests had not been cleared or authorized by the agency.

By Elise Reuter • Sept. 1, 2022

Dispute over monkeypox test reimbursement rates may hurt effort to halt disease’s spread: experts

The CMS says regional administrators can set prices, even as lab group warns fees are too low for commercial firms to conduct testing.

By Elise Reuter • Aug. 31, 2022

Illumina opens first manufacturing facility in China to supply gene sequencing products

The company aims to produce all gene sequencing instruments and consumables locally within five years in a bid to expand its presence in the growing Chinese market.

By Nick Paul Taylor • Aug. 31, 2022

Olympus to sell microscope unit for $3.1B as it bolsters focus on medical technology

Bain Capital has taken the other side of the deal, paying $3.1 billion for a business it said is “at the frontier of digital optical technology in life sciences and industrial end markets.”

By Nick Paul Taylor • Aug. 30, 2022

Labcorp adds to hospital lab buying streak with New Jersey acquisition

The purchase comes as hospitals work to trim costs and testing firms seek stable revenue streams as COVID-19 testing winds down.

By Peter Green , Rebecca Pifer • Aug. 25, 2022

Lab group ACLA warns ‘inadequate’ payment rates may limit access to monkeypox testing

The trade group urged the CMS to ensure monkeypox testing claims are paid at its “reasonably derived” recommended rate to ensure access to testing.

By Nick Paul Taylor • Aug. 23, 2022