Diagnostics: Page 8
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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 -
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 LumiraDxās 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: Illuminaās 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 ātransformativeā 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 āstring of rough yearsā
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 -
Courtesy of Hologic, Inc.
Hologic promotes Essex Mitchell to COO
Mitchell joined Hologic as vice president of sales and commercial excellence for the GYN surgical division in 2017.
By Nick Paul Taylor • Dec. 11, 2023 -
Courtesy of GE Healthcare
Advamed adds medical imaging division, names new board chair
The medtech association is bringing on staff from the Medical Imaging & Technology Alliance to lead the new division.
By Elise Reuter • Dec. 11, 2023 -
Courtesy of Becton Dickinson
BD receives 510(k) clearance for fingerstick blood test sample collection device
The clearance positions BD and partner Babson Diagnostics to support blood collection from community sites such as pharmacies.
By Nick Paul Taylor • Dec. 8, 2023 -
Courtesy of U.S. Food and Drug Administration
White House sets April target for finalization of FDA rule on lab developed tests
TD Cowen analysts said it is “unclear if and when FDA will finalize the rule as it has faced considerable opposition.”
By Nick Paul Taylor • Dec. 8, 2023 -
Courtesy of Dexcom, Nick Jonas Super Bowl kit
Dexcom, Hologic picked to outperform in 2024: William Blair
For the medtech industry overall, the analysts wrote that procedure volume growth is likely to normalize after declining due to the COVID-19 pandemic.
By Nick Paul Taylor • Dec. 7, 2023 -
Courtesy of Intuitive Ventures
Intuitiveās venture capital arm launches second investment fund
The $150 million fund will back early-stage companies focused on healthcare access, digital health, and precision diagnostics and interventions.
By Susan Kelly • Dec. 5, 2023
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