Diagnostics
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Abbott heart attack test shows early promise in small study
The diagnostic was as successful at ruling out acute myocardial infarction as a lab-based assay.
By Nick Paul Taylor • Oct. 18, 2018
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Abbott medical device, diagnostic units drive Q3 growth
CEO Miles White said Abbott plans to submit its data to FDA in the coming weeks to back an expanded indication for MitraClip.
By David Lim • Oct. 17, 2018
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FDA clears Pfizer PARP drug, Myriad companion test for breast cancer
Patients must be selected for treatment based on Myriad's test to identify those eligible for talazoparib.
By Susan Kelly • Oct. 17, 2018
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Immunodiagnostic demand powers Roche Q3 results
The 6% sales growth at the diagnostic business extends the company’s streak of positive quarters.
By Nick Paul Taylor • Oct. 17, 2018
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FDA OKs DNA-based test for blood transfusion compatibility
Grifols unit Progenika Biopharma's product is the second molecular assay approved for use in transfusion medicine and the first approved to report genotypes as final results.
By Susan Kelly • Oct. 12, 2018
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Framework aims to employ e-triggers to improve diagnostic safety
Authors writing in BMJ Quality and Safety offer tools they say would not only detect potential diagnostic events and monitor error rates but also help to identify patients at greater risk of future adverse events.
By Meg Bryant • Oct. 10, 2018
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Prostate cancer imaging agent meets one of two study endpoints
The results mark Progenics Pharmaceuticals' second clinical trial for a prostate cancer imaging agent to show mixed results in as many months.
By Susan Kelly • Oct. 08, 2018
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Karius posts clinical data on heart infection test
The test identified the pathogen affecting one of the three patients failed by traditional methods.
By Nick Paul Taylor • Oct. 05, 2018
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UK recalls 58K pregnancy tests after false positive reports
The digital displays of some devices erroneously told users they were pregnant.
By Nick Paul Taylor • Oct. 05, 2018
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European Parliament passes device-friendly changes to draft HTA law
The amendments will limit the types of devices that undergo joint clinical assessments.
By Nick Paul Taylor • Oct. 04, 2018
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Regulatory professionals working in devices paid far less than pharma peers
Reg managers in the drug industry take home around 75% more than their device counterparts.
By Nick Paul Taylor • Oct. 04, 2018
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Ready or not, medtech braces for new EU landscape
Companies should not assume they'll get extra time to adapt, warned Vicki Anastasi, VP for medical device and diagnostics research at ICON.
By Kim Dixon • Oct. 01, 2018
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FDA clears NGS test to detect residual blood cancer cells
Adaptive Biotechnologies' assay detects and monitors minimal residual disease in multiple myeloma and B-cell acute lymphoblastic leukemia patients.
By Susan Kelly • Oct. 01, 2018
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New IMDRF committee to tackle cybersecurity threats
The FDA device chief laid out takeaways from the group's Beijing meeting.
By Kim Dixon • Sept. 27, 2018
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Global device industry set to grow 5.6% a year through 2024: report
In vitro diagnostics is projected to remain as the No. 1 specialty in 2024 with annual sales of $79.6 billion and a 13.4% share of the medical device industry.
By Susan Kelly • Sept. 26, 2018
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Premier gets FDA clearance for saliva-based opioid tests
The regulatory nod expands use of OralTox to oxycodone and methadone.
By Nick Paul Taylor • Sept. 26, 2018
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Medtech companies race to adapt amid vertical integration, new tech threats
The industry is increasingly sharing the risk with payers as a way to prove product value.
By Kim Dixon • Sept. 25, 2018
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AdvaMed chief: Success in warding off tariffs, but impact rising
While medical devices aren't explicitly on the most recent list of tariffs, the list likely includes component parts used by members of the industry.
By Kim Dixon • Sept. 25, 2018
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ACLA lab payment lawsuit dismissed by judge
The clinical lab lobby had argued HHS did not collect data from a wide enough range of laboratories when establishing Medicare payment rates.
By David Lim • Sept. 24, 2018
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Medicare lab test spending up slightly in 2017: OIG
The top five tests — four common blood tests and a test for Vitamin D3 levels — totaled $2.2 billion.
By Susan Kelly • Sept. 21, 2018
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US wins kickback case against clinical lab Calloway
Calloway Laboratories is on the hook for $1.3 million for submitting false claims to Medicare and other federal healthcare programs.
By Nick Paul Taylor • Sept. 21, 2018
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Thermo Fisher licenses CRISPR tech from Broad Institute
The instruments maker aims to meet the growing demand for contracting services from companies using CRISPR in drug R&D.
By Suzanne Elvidge • Sept. 19, 2018
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MYnd gets breakthrough tag for mental health decision support tool
The technology works by comparing the brain activity of a patient to those of people with similar patterns to zero in on the drugs that have worked in analogous situations in the past.
By Nick Paul Taylor • Sept. 19, 2018
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ACLA, AdvaMedDx urge CMS to delay payment cuts
The clinical lab trade group sued HHS last year over data collection from labs used to set Medicare reimbursement rates.
By David Lim • Sept. 18, 2018
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Intermountain, Geisinger form group to improve diagnostic accuracy
The two health systems are among more than 40 organizations calling for providers to take steps like improving how doctors communicate test results.
By Meg Bryant • Sept. 14, 2018