Diagnostics: Page 58
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Cognoa's autism devices win breakthrough status
The special FDA designation covers the company's digital devices designed to improve the diagnosis and treatment of autism.
By Nick Paul Taylor • Feb. 6, 2019 -
Healthcare groups urge CMS to keep coverage of NGS cancer tests
Sixty-three healthcare companies and organizations argued the agency's approach to covering next generation sequencing will restrict cancer patients' access to essential tests.
By Susan Kelly • Feb. 5, 2019 -
Oxipit AI-based tool for chest X-ray analysis gets CE mark
The Lithuania-based startup is betting the system can help radiologists increase productivity, detect hard-to-catch pathologies, decrease error rates and serve as a second opinion.
By Susan Kelly • Feb. 4, 2019 -
Deep Dive
Clinical lab lobbying spikes as PAMA cuts kick into effect
Paralleling​ CMS payment cuts that took effect at the start of last year, lobbying by Quest Diagnostics, LabCorp and the American Clinical Laboratory Association jumped to $4.4 million, up from $2.5 million in 2017.
By David Lim • Feb. 1, 2019 -
FDA approves OPKO's point-of-care PSA test
The immunoassay provides quantitative prostate-specific antigen results within 15 minutes, eliminating the need to send samples to laboratories.
By Nick Paul Taylor • Feb. 1, 2019 -
FDA sets neurology, microbiology device panel meetings for March
Advisory committees will discuss a De Novo application for an Alzheimer's therapy and new approaches to evaluate HPV screening devices.
By Maria Rachal • Jan. 31, 2019 -
Breast health and diagnostics drive Hologic to beat-and-raise quarter
Double-digit growth by Hologic's core businesses offset ongoing underperformance by its Cynosure medical aesthetics unit.
By Nick Paul Taylor • Jan. 31, 2019 -
Thermo Fisher posts 16% yearly sales growth, 7% specialty diagnostics bump
Some analysts sought more bullish 2019 goals. But company executives are waiting to see how Brexit, the U.S. trade war with China and other tariffs play out.
By Maria Rachal • Jan. 30, 2019 -
FDA awards breakthrough status to blood test for Alzheimer's risk
Developers at St. Louis-based C2N Diagnostics think the IVD will make broad screening of patients with early memory problems practical and affordable.
By Nick Paul Taylor • Jan. 30, 2019 -
Philips hits sales targets despite headwinds and patchy performance
The trade war between the United States and China is taking a toll on the multinational conglomerate.
By Nick Paul Taylor • Jan. 29, 2019 -
Deep Dive
Why home health tech is capturing investment in 2019
Startups and established providers alike are looking at the potential for devices and technology to help patients manage and receive their treatments from the comfort of home.
By Meg Bryant • Jan. 28, 2019 -
Top Senate Republican seeks HHS answers on lab payments
The Government Accountability Office stands by its report finding that CMS could end up paying billions more than intended for lab services.
By David Lim • Jan. 28, 2019 -
Thermo Fisher expands peanut allergy test menu
The company hopes the assay will lead to more tailored, effective allergy management strategies.
By Nick Paul Taylor • Jan. 24, 2019 -
Illumina TruSight assay gets FDA breakthrough designation
The DNA sequencing company is seeking clearance of the assay as a companion diagnostic.
By Susan Kelly • Jan. 23, 2019 -
Hereditary colorectal cancer screen is 23andMe's latest FDA nod
The test will look at the two most common genetic variants influencing MUTYH-associated polyposis, which can indicate heightened risk for cancers of the colon, rectum and thyroid.
By Maria Rachal • Jan. 23, 2019 -
Abbott misses sales expectations despite device, diagnostic unit growth
The medical device unit had the strongest quarter of four divisions, with double-digit growth in sales of diabetes, electrophysiology and structural heart products fueling its performance.
By Nick Paul Taylor • Jan. 23, 2019 -
J&J to study Apple Watch with heart health app
That medtech giant said it would investigate how the product can be used by seniors to flag atrial fibrillation and prevent stroke in conjunction with a J&J heart health app.
By Maria Rachal • Jan. 18, 2019 -
FDA finalizes guidance on development of antimicrobial tests
The document is intended to improve coordination between drug and diagnostic developers.
By Nick Paul Taylor • Jan. 18, 2019 -
Top House Democrat to focus on diagnostics revamp, drug prices in 2019
With Democrats now in power, the new chair of a key oversight subcommittee laid out her priorities, including proposals she argues will bolster the Affordable Care Act.
By David Lim • Jan. 17, 2019 -
JAMA study raises questions on lung cancer screening cost-effectiveness
Researchers found complication rates far higher than the National Lung Cancer Screening Trial did in community settings.
By David Lim • Jan. 16, 2019 -
After losses to Quest, LabCorp strikes exclusive Texas testing deal
The extension of the long-term relationship comes as LabCorp faces competition for key accounts.
By Nick Paul Taylor • Jan. 16, 2019 -
Neural network matches cardiologists in EKG analysis study
Researchers think the algorithm could improve the triaging of patients.
By Nick Paul Taylor • Jan. 16, 2019 -
Medtech therapeutic areas to track in 2019
Cardiovascular health, diabetes and oncology diagnostics are among the products with greatest consumer and investor interest.
By Maria Rachal • Jan. 15, 2019 -
Uncertainties abound with growing prospect of hard Brexit
The future for medtech companies in Europe was further complicated Tuesday with Britain's government firmly rejecting PM Theresa May's EU exit deal by a vote of 432 to 202, prompting debate of a no-confidence vote Wednesday.
By Meg Bryant • Updated Jan. 16, 2019 -
5 medtech trends to watch in 2019
FDA regulatory changes, diagnostics legislation, a sustained focus on cybersecurity, looming European Union regulations and China trade headwinds are likely to take center stage.
By David Lim • Jan. 11, 2019
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