Diagnostics: Page 10
-
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 -
Explore the Trendline➔
Permission granted by Boston Scientific
TrendlineNew medical devices are reshaping the medtech industry
From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.
By MedTech Dive staff -
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 -
Getty Images
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 -
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 -
Getty Images
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 -
Getty Images
FDA holds firm on 60-day comment period for lab-developed test rule
The agency is proposing to expand its oversight of tests made by laboratories because it says risks associated with the diagnostics have increased.
By Susan Kelly • Nov. 1, 2023 -
Thermo Fisher cuts 2023 forecast, citing volatile economic conditions
Customer spending remains constrained overall, while economic conditions in China have weakened, CEO Marc Casper said on a Wednesday earnings call.
By Susan Kelly • Oct. 25, 2023 -
Courtesy of Illumina
Icahn sues to remove Illumina board members, asks for at least $476M in damages
The activist investor claims board members breached their duties in the acquisition of Grail.
By Nick Paul Taylor • Oct. 24, 2023 -
Courtesy of Abcam
Danaher Q3 revenue declines as demand challenges continue
Better-than-expected respiratory testing revenue was a bright spot, but the company’s overall orders are “bouncing along” at a bottom, CEO Rainer Blair said on a Tuesday earnings call.
By Susan Kelly • Oct. 24, 2023 -
Scott Olson via Getty Images
US trade commission explores impact of patent rules on COVID diagnostics
The USITC report presents conflicting testimony from the medtech industry and advocacy groups about the impact of compulsory licensing.
By Nick Paul Taylor • Oct. 23, 2023 -
Courtesy of Abbott
Abbott raises outlook amid strong Q3, sees momentum into 2024
Sales of the FreeStyle Libre continuous glucose monitor rose nearly 31% despite investor worries about the potential impact of weight-loss drugs on demand.
By Susan Kelly • Oct. 18, 2023 -
Spencer Platt via Getty Images
Siemens Healthineers partners to improve tuberculosis screening using AI
The company will work with the Global Fund to Fight AIDS, Tuberculosis and Malaria, providing free licenses and helping to integrate AI-enabled processes into clinicians’ workflows.
By Nick Paul Taylor • Oct. 18, 2023 -
Courtesy of Thermo Fisher Scientific
Thermo Fisher buys Olink Holding for $3.1B, pushing further into proteomics
Olink’s high-throughput protein analysis technology is expected to complement Thermo Fisher’s mass spectrometry and life sciences platforms.
By Susan Kelly • Oct. 17, 2023
Previous
