Congress skips surprise billing, passes LAB Act
December 23, 2019 -- President Donald Trump signed off on $1.4 trillion U.S. year-end spending legislation on December 20 that included the Laboratory Access for Beneficiaries (LAB) Act and did not include legislation aimed at curtailing out-of-network charges, or surprise medical billing.  Discuss
Top 10 LabPulse stories for 2019
December 23, 2019 -- Automation, artificial intelligence (AI), and utilization management were hot topics in lab medicine in 2019, at least according to the articles that were most viewed by members of LabPulse.com for the year. In fact, three out of the top five most-read stories revolved around automation and AI.  Discuss
Curetis plans Q1 U.S. launch for Unyvero pneumonia test
December 23, 2019 -- Curetis is planning a first-quarter launch in the U.S. of its Unyvero lower respiratory tract infection cartridge for bronchoalveolar lavage samples, after the product was granted 510(k) clearance by the U.S. Food and Drug Administration.
FTC blocks Illumina's PacBio buyout
December 18, 2019 -- The U.S. Federal Trade Commission (FTC) is blocking Illumina's planned $1.2 billion acquisition of Pacific Biosciences of California (PacBio) on the grounds that the deal would be anticompetitive.
Paige raises $45M, vows deeper dive into AI, cancer pathology
December 18, 2019 -- Artificial intelligence (AI) pathology company Paige has raised $45 million in a series B round and said it plans to use the cash to expand its portfolio, get products approved in the U.S., and rev up its commercial efforts in key global markets.
Out-of-network billing study points finger at pathologists
December 17, 2019 -- Out-of-network billing by pathologists and other specialists costs the healthcare system big bucks -- to the tune of $40 billion a year in the U.S. -- and needs to be remedied, Yale University researchers reported on December 16 in the journal Health Affairs.  Discuss
FDA clears DiaSorin's Simplexa varicella-zoster virus test
December 17, 2019 -- DiaSorin Molecular's Simplexa DNA swab test for the varicella-zoster virus is now cleared by the U.S. Food and Drug Administration (FDA).
Labs gear up to meet demand for genetic testing
December 16, 2019 -- Genetic testing and gene sequencing represent a paradigm shift in testing, but labs still have some time to develop a winning strategy for adapting to the new direction in which the field is heading.  Discuss
Labs may add 1st test for Duchenne muscular dystrophy
December 16, 2019 -- The U.S. Food and Drug Administration has cleared the first screening test for the rare genetic condition Duchenne muscular dystrophy -- PerkinElmer's GSP Neonatal Creatine Kinase-MM kit -- through its de novo premarket review pathway.
FDA moves to electronic-only device submissions
December 13, 2019 -- The U.S. Food and Drug Administration (FDA) now requires medical device premarket submissions to be sent electronically, eliminating the need for multiple paper submissions.