Diagnostics: Page 3
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European Council approves extension of IVDR transition
The Council expects the European Parliament to vote on the plan, without seeking amendments, in April.
By Nick Paul Taylor • Feb. 26, 2024 -
Permission granted by QuidelOrtho
QuidelOrtho fires CEO Doug Bryant
Bryant, who led the company since 2009, was fired after a challenging quarter and confusion over earnings forecasts.
By Elise Reuter • Feb. 21, 2024 -
Explore the Trendline➔
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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 -
UK medical device reviewers form new association
The group intends to help the medical device sector navigate a post-Brexit regulatory landscape.
By Susan Kelly • Feb. 20, 2024 -
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Freenome raises $254M to study cancer screening tests
Roche and Quest Diagnostics were among those to invest in the company’s development of early cancer detection blood tests.
By Nick Paul Taylor • Feb. 16, 2024 -
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Invitae files for Chapter 11 bankruptcy
The genetic testing company hopes to keep its employees on payroll as it works through a court-overseen sale.
By Elise Reuter • Feb. 14, 2024 -
Courtesy of Cue Health Press Kit
Cue Health axes more jobs amid declining test sales
The company cut 94 workers at the beginning of last month and another 151 people on Jan. 25.
By Elise Reuter • Feb. 9, 2024 -
Permission granted by Illumina
Illumina cut 12% of global staff over past year: CEO
The genomics company, which initiated a fresh round of layoffs last month, expects to finalize its Grail divestiture by the end of June, Jacob Thaysen said Thursday.
By Susan Kelly • Feb. 9, 2024 -
Courtesy of Illumina
Illumina to lay off 111 people at San Diego headquarters
The job cuts, expected by March 12, include senior management positions, scientists and engineers.
By Susan Kelly • Feb. 8, 2024 -
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Invitae hires advisers, considers bankruptcy: WSJ
Sources told the Wall Street Journal a bankruptcy filing could come within weeks.
By Susan Kelly • Feb. 7, 2024 -
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Hologic wins FDA clearance for AI-enabled cervical cancer screening system
The product creates digital images of Pap test slides and uses an AI algorithm to identify cells for review.
By Nick Paul Taylor • Feb. 5, 2024 -
Permission granted by Veeva Systems
FDA to reclassify most high-risk IVDs, easing path to clearance
The effort comes ahead of the regulator’s plan to finalize a rule that would expand its oversight of laboratory-developed tests.
By Susan Kelly • Feb. 5, 2024 -
Joe Raedle/Getty Images via Getty Images
Califf backs increased LDT oversight despite industry opposition
At a Wednesday event, the FDA commissioner named the laboratory-developed test proposal as a top priority and addressed questions on AI.
By Ricky Zipp • Feb. 1, 2024 -
Courtesy of BD
BD partners with Techcyte to offer AI-enhanced cervical cancer screening
Techcyte has developed a system to reduce the amount of cells pathologists need to review.
By Nick Paul Taylor • Feb. 1, 2024 -
Permission granted by Agilent
Agilent, Incyte to partner on companion diagnostics
The collaboration comes after Agilent restructured and sold its liquid biopsy unit.
By Elise Reuter • Jan. 30, 2024 -
Courtesy of Abbott
Abbott says all four segments stronger than pre-pandemic
CEO Robert Ford said investing in its base business using COVID-19 testing revenues was “absolutely the right strategy.”
By Elise Reuter • Jan. 24, 2024 -
Carl Court via Getty Images
European Commission proposes delays for IVDR to prevent supply disruption
Officials are planning to give manufacturers another 31 months to get tests certified under the In Vitro Diagnostic Medical Devices Regulation.
By Nick Paul Taylor • Jan. 24, 2024 -
Nastassia Samal via Getty Images
Invitae sells reproductive health assets amid liquidity concerns
DNA testing firm Natera could pay up to $52.5 million total, and plans to move Invitae’s customers to its own tests.
By Elise Reuter • Jan. 22, 2024 -
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3 bellwether companies to watch as medtech earnings season begins
J&J, Intuitive Surgical and Abbott kick off this week with fourth-quarter reports.
By Nick Paul Taylor • Jan. 22, 2024 -
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FDA, CMS defend plans to increase oversight of laboratory developed tests
In a joint letter Thursday, leaders from the agencies outlined why they are opposed to using the Clinical Laboratory Improvement Amendments to address concerns with LDTs.
By Nick Paul Taylor • Jan. 19, 2024 -
Sarah Silbiger via Getty Images
FDA authorizes record number of new devices in 2023
The FDA shared the figures in the CDRH’s annual report, which also features updates on its work on MDUFA V goals.
By Nick Paul Taylor • Jan. 18, 2024 -
Courtesy of Dermasensor
Dermasensor wins FDA clearance for AI-enabled skin cancer detection device
A study found the sensitivity of the device was 96%, compared with 83% for primary care physicians.
By Nick Paul Taylor • Updated Jan. 22, 2024 -
Stock via Getty Images
Imvaria and Darmiyan receive FDA authorizations for AI-enabled diagnostic tools
The de novo classifications cover software for detecting a lung condition and assessing dementia risk.
By Nick Paul Taylor • Jan. 17, 2024 -
Retrieved from Wikimedia Commons on December 15, 2021
UK shares roadmap for creation of new medtech regulatory framework
The MHRA plans to have the “core elements” of the new framework for medical devices in place by the next year.
By Nick Paul Taylor • Jan. 12, 2024 -
Courtesy of Boston Scientific
Deep Dive5 medtech trends to watch in 2024
From the M&A outlook and tough year-over-year comparisons to emerging markets like pulsed field ablation, here are the top medical technology trends to watch this year.
By Ricky Zipp • Jan. 9, 2024 -
Permission granted by Delfi
Susan Tousi leaves Illumina to become CEO of liquid biopsy firm Delfi
Tousi is in charge of commercializing the lead liquid biopsy from a company that could compete with Grail, the multi-cancer early detection test maker Illumina plans to divest.
By Nick Paul Taylor • Jan. 9, 2024
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