Diagnostics: Page 3
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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 -
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 -
Trendline
Medical 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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
Masimo wins de novo authorization for measure of high blood oxygen levels
The ORi device is intended to support standard pulse oximetry by providing additional insights into patients with higher than normal oxygenation.
By Nick Paul Taylor • Oct. 16, 2023 -
Illumina details EC timeline, funding requirements for Grail divestment
The European Commission ordered the gene sequencing company to support Grail with two-and-a-half years of funding if it pursues a spinoff.
By Susan Kelly • Oct. 13, 2023 -
FDA prioritizes guidance on AI, cybersecurity, pulse oximeters in stacked schedule for 2024
The administration is ramping up production of medtech guidance, adding 18 draft documents to the list of priorities for the upcoming financial year.
By Nick Paul Taylor • Oct. 13, 2023 -
European Commission orders Illumina to divest Grail
The order includes an undisclosed timeline and potential additional fines. Illumina, which has been anticipating the decision, maintains the commission does not have jurisdiction over the completed merger.
By Susan Kelly • Oct. 12, 2023