FDA: Page 92
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FDA draft lays out submission paths for combo products
Commissioner Scott Gottlieb said the agency will develop additional guidances outlining specific premarket considerations for combo products.
By David Lim • Feb. 6, 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 -
Explore the Trendline➔
Permission granted by Boston Scientific
TrendlineNew medical devices are reshaping the medtech industry
From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.
By MedTech Dive staff -
Current Health's wearable vital sign monitor gets FDA nod
The 510(k) clearance covers an arm-worn device that monitors variables such as oxygen saturation and alerts healthcare professionals to deviations.
By Nick Paul Taylor • Feb. 6, 2019 -
Trump light on trade details in State of the Union address
The President's comments on trade were short and direct, calling for passage of the United States-Mexico-Canada Agreement (USMCA) and the lesser-known Reciprocal Trade Act.
By Emma Cosgrove • Feb. 5, 2019 -
Deep Dive
CMS eases study parameters in depression device coverage decision
LivaNova seeks to enroll clinical trial patients beginning in the third quarter of 2019. Those patients will only need to demonstrate response rather than remission, per CMS updates to the finalized decision memo.
By Maria Rachal • Updated Feb. 19, 2019 -
FDA warns cardiologists of high mortality in Abiomed post-approval study
The 17% survival rate in the post-approval study of its Impella temporary right heart pump system prompted FDA to write to healthcare professionals and wiped 6% of Abiomed's stock.
By Nick Paul Taylor • Feb. 5, 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 -
FDA redefines 'least burdensome' as critics fear chilling effect on reviewers
A watchdog argues the guidance is the agency's latest step to speed device approvals at the expense of robust patient protection.
By David Lim • Feb. 5, 2019 -
Jacob Bell/MedTech Dive
FDA announces warfarin test strips, IV fluid transfer systems recalls
The agency identified separate Class I recalls addressing malfunctions in certain Roche Diagnostics test strips and Vial2Bag fluid transfer systems made by West Pharmaceutical Services.
By Susan Kelly • Feb. 4, 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 -
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 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 -
HHS to seek changes to anti-kickback laws by year end
The bid to overhaul the Stark Law and Anti-Kickback Statute comes as lawmakers propose legislation to facilitate value-based arrangements connecting the price of a medical device or drug to clinical effectiveness.
By David Lim • Jan. 31, 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 -
Gottlieb, Shuren tout 2018 as 'record' year for novel devices
The FDA officials also cited progress with real world evidence, pondered expanding authorities to revamp the 510(k) system and floated creating a fast-track pathway for products addressing non-life-threatening diseases.
By Maria Rachal • Jan. 29, 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 -
Draeger Medical recalls single-use breathing circuits
The accessory works with a ventilator or anesthesia machine and could cause severe oxygen loss or death if the breathing hose short circuits and patients do not receive ventilation.
By Susan Kelly • Jan. 28, 2019 -
FDA grants breakthrough status to Liberate's ventilator device
The special designation covers a muscle stimulator designed to wean patients off mechanical ventilation.
By Nick Paul Taylor • Jan. 25, 2019 -
Device lobby pushes bill to let FDA take user fees amid shutdown
But the proposal does not appear to be poised for movement. Democrats on the House Energy & Commerce Committee oppose the legislation, a Democratic committee staffer told MedTech Dive.
By David Lim • Jan. 24, 2019 -
Duke report identifies barriers to adoption of AI healthcare systems
The authors think more evidence and effective risk management will be necessary before AI plays a major role in the diagnosis of disease.
By Nick Paul Taylor • Jan. 24, 2019 -
Hospitals call on medtech to ease interoperability by boosting security
"Medical device manufacturers must do more to confront the privacy challenges that unsecurable devices may pose to hospitals and health systems," the American Hospital Association and six other groups said in a report.
By Meg Bryant • 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 -
FDA expands Abbreviated 510(k) guidance, seeks predicate input
FDA Thursday extended the comment period by 30 days for its request for feedback on its proposal to overhaul the 510(k) program to encourage use of more modern predicate devices.
By David Lim • Updated April 12, 2019 -
Sponsored by ZS
How the FDA's new 510(k) guidelines could help or hurt medtech
Recently, the FDA announced new steps to modernize its 510(k) regulatory clearance pathway. Three major changes will impact medtech companies.
By Matt Singer and Sundeep Karnik • Jan. 22, 2019 -
NESTcc plans pay-for services once FDA funding ends
Once a business plan is in place, the Medical Device Innovation Consortium's real-world evidence center intends to create products and services to sell to the medical device industry.
By Nick Paul Taylor • Jan. 22, 2019
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