Diagnostics: Page 58
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FDA warns breast infrared imaging tool should not replace mammography
Total Thermal Imaging's thermography system has not been cleared as a standalone diagnostic tool, and the technology lacks scientific evidence to support its use in breast cancer screening, the agency said.
By Susan Kelly • Feb. 26, 2019 -
Philips' camera-guided digital imaging system gets FDA OK
The nod comes after Philips reported fourth quarter growth in image-guided therapy, ultrasound and diagnostic imaging.
By Meg Bryant • Feb. 21, 2019 -
Explore the Trendline➔
Sara Silbiger via Getty Images
TrendlineTop 5 stories from MedTech Dive
From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
Intuitive gains FDA clearance for Ion lung catheter
The robot-assisted surgery pioneer said it plans a measured U.S. rollout of the system with customer shipments beginning in the second quarter.
By Susan Kelly • Feb. 20, 2019 -
ACLA, AdvaMedDx clash on lab test overhaul bill
The latest version of draft legislation incorporated suggestions from FDA, including a precertification program. The Pew Charitable Trusts cautioned that may open up patients to risk from unreviewed products.
By David Lim • Feb. 20, 2019 -
FDA grants breakthrough status to concussion-detecting VR headset
The SyncThink device analyzes the wearer's eye movements. The medtech has deals with the Golden State Warriors and hospitals including Mass General.
By Nick Paul Taylor • Feb. 20, 2019 -
FDA grants breakthrough status to amyloid beta Alzheimer's test
The assay analyzes the ratio of two forms of amyloid beta in cerebrospinal fluid to help determine if a patient has Alzheimer's.
By Nick Paul Taylor • Feb. 15, 2019 -
Headwinds stiffen as Quest revenues, earnings miss Q4 estimates
Elements of the fourth quarter financial results align with performance of chief rival LabCorp. Both companies are contending with Medicare rate reductions as a result of PAMA.
By Nick Paul Taylor • Feb. 14, 2019 -
Software products face high-risk upclassing in Australia
The Therapeutic Goods Administration wants to significantly increase the regulatory burden on medical software, with some products potentially jumping from the lowest to highest risk category.
By Nick Paul Taylor • Feb. 14, 2019 -
GenomeDx pays $2M to settle genetic test false claims allegations
The U.S. government accused the company of billing Medicare for unnecessary prostate cancer tests.
By Nick Paul Taylor • Feb. 13, 2019 -
Industry strikes back at GAO's 'flawed and dangerous' PAMA report
AdvaMedDx and the other trade groups want to meet with the watchdog to discuss the dispute over the contention the payment law would cost Medicare billions rather than save.
By Nick Paul Taylor • Feb. 13, 2019 -
Rapid test for brain injury gets FDA breakthrough status
The test measures protein biomarkers released from the brain into the bloodstream after a head trauma, producing results in as little as 90 seconds.
By Susan Kelly • Feb. 12, 2019 -
LabCorp diagnostics' operating income tumbles as PAMA hits home
Reimbursement changes wiped $18 million off LabCorp's adjusted operating income, contributing to a 22% drop at the diagnostics unit.
By Nick Paul Taylor • Feb. 7, 2019 -
FDA categorizes Edwards' cardiac diagnostic recall as Class I event
Edwards pulled the catheters from the market after learning that an assembly error was causing the devices to display inaccurate information.
By Nick Paul Taylor • Feb. 7, 2019 -
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
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