Diagnostics: Page 4
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EU poised to mandate Illumina sell Grail liquid biopsy unit: FT
Regulators could order the divestment of the business as soon as next week to punish Illumina for defying their authority and “illegally” acquiring Grail.
By Nick Paul Taylor • Oct. 10, 2023 -
Delfi launches lung cancer blood test based on DNA fragmentation
The test, FirstLook Lung, applies machine learning to whole-genome sequencing data to identify cfDNA patterns associated with lung cancer.
By Nick Paul Taylor • Updated Oct. 9, 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 -
Q&A
GE HealthCare imaging CEO Jan Makela talks Mayo Clinic partnership
GE and Mayo Clinic plan to collaborate on imaging, artificial intelligence and cancer treatment.
By Elise Reuter • Oct. 6, 2023 -
Dana-Farber spinout Precede exits stealth with blood test technology and $57M
Precede has used the money to develop a platform that reveals the activity of genes and pathways.
By Nick Paul Taylor • Oct. 5, 2023 -
Labcorp buys Baystate’s outreach lab business, furthering consolidation blitz
The deal, Labcorp’s fourth outreach takeover since May, will give the company control of service centers in Massachusetts.
By Nick Paul Taylor • Oct. 5, 2023 -
Duke researchers find app improves autism screening in NIH-funded study
Participants who screened positive for autism had a nearly 41% probability of being diagnosed with the condition.
By Nick Paul Taylor • Oct. 4, 2023 -
Invitae test for hereditary cancers gains FDA de novo nod
The test analyzes DNA from a single blood sample to identify hundreds of variants in 47 genes associated with predispositions for a range of cancer types.
By Susan Kelly • Oct. 3, 2023 -
Mayo Clinic partner earns 510(k) clearance for heart failure screening algorithm
The algorithm analyzes 12-lead ECGs to show if a patient may be developing heart failure.
By Nick Paul Taylor • Oct. 2, 2023 -
FDA to regulate lab-developed tests under proposed rule
The tests have come under scrutiny by the agency and lawmakers, but the FDA is still likely to face pushback on the changes.
By Elise Reuter • Sept. 29, 2023 -
FDA posts guidance on how to simplify updates to antimicrobial resistance tests
The advice focuses on predetermined change control plans, a mechanism the regulator sees as a way to streamline updates in multiple areas.
By Nick Paul Taylor • Sept. 29, 2023 -
Harbinger Health raises $140M to study blood-based cancer screening test
The test developer will use the series B funding to complete a 10,000-subject clinical trial ahead of a planned launch in 2025.
By Nick Paul Taylor • Sept. 28, 2023 -
FDA shares draft medical device harmonization plan to meet MDUFA V goal
The FDA outlined deadlines for actions it will take, including creating a mechanism for working with regulatory partners.
By Nick Paul Taylor • Sept. 25, 2023 -
Hologic allies with Bayer to support uptake of contrast-enhanced mammography
The companies will provide a product package and training intended to support adoption of the imaging technique.
By Nick Paul Taylor • Sept. 22, 2023 -
Is bigger better? McKinsey predicts the return of large medtech mergers
The analysts argue that pressure to improve margins and become the partner of choice to hospitals favors large deals.
By Nick Paul Taylor • Sept. 22, 2023 -
Limited resources constrain federal oversight of medical device ads, GAO finds
U.S. agencies took 322 enforcement actions related to medtech advertising between 2018 and 2022.
By Nick Paul Taylor • Sept. 21, 2023 -
CMS leader defends breakthrough device reimbursement proposal at House hearing
Dora Hughes made the case for restricting the Transitional Coverage for Emerging Technologies pathway to five reviews a year.
By Nick Paul Taylor • Sept. 20, 2023 -
MedTech Europe says MDR, IVDR framework needs ‘structural reform’
Patients may face delayed access to treatments unless changes are made to the new regulatory system, 35 European trade groups warned in an open letter.
By Susan Kelly • Sept. 18, 2023 -
FDA finalizes breakthrough device changes to target health inequities
The proposals received positive feedback from groups including AdvaMed, leading the FDA to finalize the changes with only minor revisions.
By Nick Paul Taylor • Sept. 18, 2023 -
GE HealthCare partners with Mayo Clinic to accelerate work on imaging and AI
The organizations will collaborate on the application of AI to MRI and the automation of diagnostic and interventional ultrasound.
By Nick Paul Taylor • Sept. 15, 2023 -
Study suggests AI could provide second reading of mammograms
In a separate commentary, researchers described the study as launching “the arrival of prospective trials of AI in the breast screening setting.”
By Elise Reuter • Sept. 12, 2023 -
Walgreens to pay $44M to settle claims over fraudulent Theranos tests
If a judge approves the settlement, patients who bought a Theranos blood test would receive double the amount they paid for it.
By Elise Reuter • Sept. 8, 2023 -
Microsoft, Paige team to use supercomputers to train cancer pathology AI models
Microsoft will support development of a new model that is “orders-of-magnitude larger” than any in use today.
By Nick Paul Taylor • Sept. 8, 2023 -
FDA proposes 3 guidances to improve 510(k) clearance process
The agency has made recommendations for selecting predicate devices, using clinical data and conducting performance testing for implants.
By Nick Paul Taylor • Sept. 7, 2023 -
Cue Health board pressured by investor to review strategy, cut costs
Tarsadia Investments called for the board to “take immediate action to prevent further destruction of stockholder value.”
By Nick Paul Taylor • Sept. 6, 2023 -
Guardant abandons cancer blood test trial early, restates confidence in product line
Guardant stopped enrolling new patients in the study because of its design and use of an older generation test, analysts said.
By Nick Paul Taylor • Sept. 6, 2023