Diagnostics: Page 9
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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 -
Explore the Trendline➔
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TrendlineTop 5 stories from MedTech Dive
From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
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 -
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
Intuitive’s 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 -
Karen Ducey via Getty Images
Laboratory trade group, providers oppose FDA’s lab developed test proposal
A CDRH spokesperson confirmed to MedTech Dive that a discrepancy in the submission system used for the proposed rule led to an initial overcount of public comments.
By Nick Paul Taylor • Updated Dec. 7, 2023 -
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GE HealthCare, Hologic put AI at center of radiology pitches
BTIG analysts said GE HealthCare believes AI can help clinicians and radiologists do their jobs better, which is important due to the “ongoing shortage of radiologists and the high rates of burn out.”
By Nick Paul Taylor • Dec. 1, 2023 -
Justin Sullivan via Getty Images
Labcorp to lay off 239 workers in New Jersey amid biotech slump
The job cuts are slated for the lab services company’s early development business, which has seen orders fall and cancellations increase as the biotech sector struggles.
By Susan Kelly • Nov. 22, 2023 -
Sarah Silbiger via Getty Images
LetsGetChecked secures first FDA authorization for at-home chlamydia and gonorrhea test
Jeff Shuren, director of the Center for Devices and Radiological Health, said the test will give patients “more information about their health from the privacy of their own home.”
By Nick Paul Taylor • Nov. 16, 2023 -
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Congress delays Medicare lab payment cuts for one year
The American Clinical Laboratory Association said it remains focused on getting legislation passed that would mitigate pending Medicare payment reductions.
By Susan Kelly • Nov. 16, 2023 -
Win McNamee/Getty Images via Getty Images
Biden initiative aims to accelerate women’s health research
AdvaMed endorsed the White House effort, stressing the need for equitable development and funding of new technologies.
By Susan Kelly • Nov. 14, 2023 -
Courtesy of Grail
Illumina explores options for Grail, hires advisers
The company, facing pressure from regulators to divest Grail, also formed a special committee to speed decisions on the fate of the liquid biopsy test maker.
By Susan Kelly • Nov. 10, 2023 -
Phil Walter via Getty Images
Acon receives first FDA clearance for over-the-counter COVID-19 antigen test
The FDA is encouraging manufacturers to transition to traditional review pathways now that the acute phase of the COVID-19 crisis is over.
By Nick Paul Taylor • Nov. 10, 2023 -
Retrieved from Siemsens Website on July 01, 2022
Siemens Healthineers’ Varian rebounds; execs mum on diagnostics sale rumors
The company's diagnostics unit continued to struggle amid layoffs and reports of a potential sale.
By Nick Paul Taylor • Nov. 8, 2023 -
Chip Somodevilla via Getty Images
White House orders HHS to start collecting reports on the safety of AI in healthcare
President Joe Biden outlined the planned program as part of an executive order on “safe, secure, and trustworthy” artificial intelligence.
By Nick Paul Taylor • Nov. 1, 2023
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