Diagnostics: Page 8
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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 -
Mario Tama via Getty Images
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 -
deliormanli via Getty Images
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 -
Thermo Fisher to lay off 74 California workers in restructuring
The scientific instruments maker, which has been streamlining operations to cut costs, said the latest job reductions would be effective Feb. 1.
By Susan Kelly • Jan. 5, 2024 -
K-Kwanchai via Getty Images
Medicare spending on lab tests fell 10% in 2022, OIG finds
The decline was driven by lower volumes across most types of tests, including genetic and COVID-19 tests.
By Elise Reuter • Jan. 4, 2024 -
Courtesy of Roche
Roche to buy LumiraDx’s point-of-care technology for $295M
LumiraDx faces financial pressures amid declining test sales and a potential delisting from the Nasdaq.
By Elise Reuter • Jan. 2, 2024 -
Courtesy of Grail
Roundup: Illumina’s long goodbye to cancer test maker Grail
From the start, the DNA sequencing leader faced pressure to unwind its $8 billion acquisition of the cancer screening developer. As 2023 drew to a close, it has finally agreed.
By Susan Kelly • Dec. 21, 2023 -
Sarah Silbiger via Getty Images
FDA approves first DNA test for risk of opioid use disorder
The approval comes a little over one year after an FDA advisory committee overwhelmingly voted against an earlier version of the test.
By Ricky Zipp • Dec. 20, 2023 -
Permission granted by Grail
Grail CEO predicts ‘transformative’ 2024 amid Illumina split
The liquid biopsy maker, which Illumina plans to divest, said it has made progress on a PMA application with the FDA for its Galleri multi-cancer early detection test.
By Susan Kelly • Dec. 19, 2023 -
Courtesy of Illumina
Illumina to part with Grail, ending battle with regulators
Activist investor Carl Icahn, who is suing the company over its acquisition of Grail, continued to push for the removal of several board members in a letter to fellow shareholders.
By Susan Kelly • Dec. 18, 2023 -
Martin Barraud via Getty Images
BTIG analysts optimistic medtech will rebound in 2024 after ‘string of rough years’
Rising interest rates, fears about the impact of GLP-1 drugs and “choppy supply-chain dynamics” dragged on the industry this year, the analysts wrote.
By Nick Paul Taylor • Dec. 18, 2023 -
Mohammed Haneefa Nizamudeen via Getty Images
Freenome starts 20,000-subject study of lung cancer blood test
The privately held company claims its test could offer an alternative to CT imaging, which exposes people to radiation.
By Nick Paul Taylor • Dec. 14, 2023 -
Courtesy of Illumina
Illumina prepares to divest Grail with Form 10 filing
The DNA sequencer is preparing to unwind its 2021 acquisition of the liquid biopsy test maker while still appealing orders to do so from regulators in the U.S. and Europe.
By Susan Kelly • Dec. 13, 2023
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