Diagnostics: Page 30
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Courtesy of Quest Diagnostics
Labs urge HHS to back new regulatory regime for diagnostic tests
The trade group for Quest, LabCorp and others wants the Biden administration to back legislation to create a framework for laboratory developed tests separate from medical devices.
By Susan Kelly • May 24, 2021 -
Danielle Ternes
FDA 'working around the clock' with COVID-19 workload, all reviews impacted: CDRH chief
Jeff Shuren said Wednesday the agency might miss some Medical Device User Fee Amendments performance goals for PMA applications and 510(k) submissions.
By Greg Slabodkin • May 20, 2021 -
Explore the Trendline➔
Sitthiphong via Getty Images
TrendlineMedical 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 -
Sean Gallup via Getty Images
FDA opposes COVID-19 antibody testing to assess post-vaccination immunity
The warning comes as some medtechs bet on the tests. Beckman Coulter unveiled a fully quantitative one just as the agency issued the safety notice.
By Nick Paul Taylor • May 20, 2021 -
OrbiMed, RA Capital top healthcare investors in Q1: CB Insights
OrbiMed topped the list in part because of the investment firm's activity in the medtech industry, where it put money into companies including AnchorDx, Noctrix Health and Adicon.
By Nick Paul Taylor • May 19, 2021 -
Courtesy of Exact Sciences
US panel trims colorectal cancer screening age, opens door to annual Cologuard use
William Blair said the recommendations are a positive for Exact Sciences, which has framed the guidance as a chance to drive growth by targeting 19 million people in the screening cohort.
By Nick Paul Taylor • May 19, 2021 -
Adeline Kon/Healthcare Dive/MedTech Dive
PerkinElmer inks $155M Immunodiagnostic buyout, continuing deal spree
The flurry of M&A means PerkinElmer has struck more deals, at a higher aggregate value, in the first six months of 2021 than in the years since it bought Euroimmun for $1.3 billion in 2017.
By Nick Paul Taylor • May 18, 2021 -
Cue raises $235M to build on point-of-care COVID-19 testing
Updates from Abbott and Quidel suggest the U.S. market for rapid COVID-19 tests has softened in recent months, but the San Diego startup still expanded its investor syndicate to raise its biggest financing round yet.
By Nick Paul Taylor • May 14, 2021 -
Nathan Howard via Getty Images
Thermo Fisher, Quest step up K-12 COVID-19 testing as school districts look to safely reopen
Color Health and Thermo Fisher are providing tests to students, teachers and staff as part of a screening pilot in Ohio, while Quest has teamed up with Ginkgo Bioworks to offer pooled testing to schools across the U.S.
By Nick Paul Taylor • May 13, 2021 -
Stefani Reynolds / Stringer via Getty Images
Lawmakers, industry urge CMS to push breakthrough payment rule as May 15 deadline looms
Amid speculation of another delay, Democrats in Congress wrote to acting CMS administrator Liz Richter voicing support for the Medicare Coverage for Innovative Technology rule.
By Nick Paul Taylor • May 13, 2021 -
Lintao Zhang / Staff via Getty Images
EU plans to impose additional regulations on medtech AI products, other 'high-risk' systems
The proposed legal framework, which addresses potential artificial intelligence risks, seeks to regulate the technology and issue fines for noncompliance that could total billions of dollars, positioning Europe for a leading AI role globally.
By Nick Paul Taylor • May 12, 2021 -
Alex Wong via Getty Images
CMS implementation of breakthrough payment rule may be further delayed: Cowen
The agency will most likely push the start date back further to address the concerns of critics of the contentious Medicare Coverage of Innovative Technology initiative, an analyst contends.
By Nick Paul Taylor • May 10, 2021 -
Permission granted by Quidel Corporation
Quidel says COVID-19 testing 'not forecastable' as it targets alternative, at-home markets
CEO Doug Bryant on Thursday's first-quarter earnings call said the company sees increasing revenue opportunities tied to at-home, back-to-school and back-to-work tests but "it's impossible for us to model at this stage."
By Greg Slabodkin • May 7, 2021 -
Mario Tama via Getty Images
NeoGenomics inks $390M Inivata buyout to enter liquid biopsy space
William Blair analysts wrote that NeoGenomics got a good price by setting the buyout fee last year.
By Nick Paul Taylor • May 6, 2021 -
Courtesy of BD/PRNewswire
BD grows Q2 revenue despite COVID-19 test dip, spins off diabetes business
The spin off for the separate publicly traded company is expected to be completed in the first half of calendar year 2022. The move will not impact BD's ability to fulfill orders related to COVID-19 vaccinations, execs said.
By Greg Slabodkin • May 6, 2021 -
Sarah Silbiger via Getty Images
AI, digital health feature in latest batch of FDA breakthrough device designations
The agency granted regulatory privileges to artificial intelligence products, including software designed to enable the early detection of cancer and technology to help surgeons tell if cancer is still present after surgical excision.
By Nick Paul Taylor • May 5, 2021 -
Courtesy of Qiagen
Qiagen braces for COVID-19 testing volatility as sales hold steady in Q1
Coronavirus-related revenues were flat sequentially, helping the company to grow above its outlook. However, the consistency masks changes in where tests are in demand with region-to-region variability expected to continue.
By Nick Paul Taylor • May 4, 2021 -
Alex Wong via Getty Images
LabCorp inks $150M takeover of Myriad Genetics autoimmune testing unit
The diagnostics giant discussed its interest in M&A last week, outlining plans to use up to $2 billion in free cash flow to strengthen its businesses through acquisitions.
By Nick Paul Taylor • May 4, 2021 -
Courtesy of Siemens Healthineers
Siemens raises outlook as COVID-19 antigen tests blast past original sales target
The company's bullish prospect for its rapid antigen test business comes as rivals like Abbott Laboratories and Quidel, which are more exposed to the U.S. market, fell short of expectations in the first quarter.
By Nick Paul Taylor • May 3, 2021 -
MIND_AND_I/iStock / Getty Images via Getty Images
Illumina sues European Commission to block competition probe into Grail buyout
The EU probe is the latest glitch in the takeover bid, which was panned by Wall Street and also faces scrutiny from the FTC. Analysts have said Exact Sciences could benefit from delays.
By Nick Paul Taylor • April 30, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from Flickr.
Hologic, Thermo Fisher cautious on COVID-19 test demand as vaccines roll out
Hologic CEO Stephen MacMillan told investors late Wednesday demand has fallen significantly since January amid vaccinations. Both companies expect recent M&A to be a crucial part of post-pandemic strategies.
By Greg Slabodkin • April 29, 2021 -
CMS pitches extra year of add-on payments for Boston Scientific, Stryker, other devices
Boston Scientific's Eluvia drug-eluting stent, Cook Medical's Hemospray and Stryker's SpineJack system are among those that would get the extension under the proposed fiscal 2022 inpatient hospital rule.
By Nick Paul Taylor • April 28, 2021 -
Abbott
Abbott, Quest look to post-pandemic home testing beyond COVID-19
With development of at-home coronavirus tests, the companies see opportunities for over-the-counter and direct-to-consumer diagnostics for other diseases and conditions, from respiratory ailments to cancer.
By Greg Slabodkin • April 27, 2021 -
GE Healthcare grows sales as routine screening, elective procedures return
The results provide further evidence that the resumption of elective procedures has driven up demand for imaging and other healthcare products and services. GE saw volumes return for cardiac, oncology and neurology screening.
By Nick Paul Taylor • April 27, 2021 -
Permission granted by Quidel Corporation
Quidel shakes Wall Street with bearish COVID-19 test forecast
The company late Thursday pre-announced first-quarter revenue nearly $100 million below analyst expectations, with Craig-Hallum's Alex Nowak now calling the business unforecastable.
By Greg Slabodkin • April 23, 2021 -
National Institute of Allergy and Infectious Disease. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from Flickr.
Science groups urge caution against using certain COVID-19 test data
The Association for Molecular Pathology and the Infectious Diseases Society of America say relying on cycle threshold (Ct) values runs the risk of being misinterpreted due to a lack of standardization across test methods.
By Susan Kelly • April 23, 2021
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