FDA: Page
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UK steps up no-deal planning as Brexit clock ticks down
MHRA updated its advice on registering devices against a backdrop of concerns about supply disruptions.
By Nick Paul Taylor • March 21, 2019 -
FDA warns Sientra, J&J's Mentor on lax post-approval breast implant studies
The action comes a week before the agency is set to hold a public meeting on risks related to the controversial devices.
By Susan Kelly • Updated March 20, 2019 -
Explore the Trendline➔
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TrendlineTop 5 stories from MedTech Dive
From the effects of layoffs at the Food and Drug Administration and President Donald Trump’s tariff policies to the top medtech trends of 2026, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
Alzheimer's device De Novo on the line at FDA panel
An advisory committee got started on a transcranial magnetic stimulation device Thursday morning, coming the same day as Biogen halted trials of one of the last late stage drug candidates to treat the disease.
By Susan Kelly • March 20, 2019 -
Lab industry pushes CMS to withdraw 'highly disruptive' coding changes
Nine trade groups called for reversal of certain lab and pathology section updates to National Correct Coding Initiative policy manuals.
By Nick Paul Taylor • March 20, 2019 -
Abbott gets CE mark for molecular diagnostics machine
The device expands the company's fast-selling portfolio of Alinity laboratory testing instruments.
By Nick Paul Taylor • March 20, 2019 -
FDA outlines new device priorities in budget justification report
A new agency document sheds light on proposed initiatives related to cybersecurity, approval pathways and special controls.
By Susan Kelly • March 19, 2019 -
Breast implants, metal hips and other device materials under new FDA scrutiny
Symptoms such as fatigue, rash, joint and muscle pain or weakness may not appear until years after a device is implanted, FDA said.
By David Lim • March 18, 2019 -
Jacob Bell/MedTech Dive
JDRF-backed Korean medtech gets breakthrough nod for closed loop system
EOFlow is developing a closed loop automated insulin delivery system for people with Type 1 diabetes as more companies aim to introduce alternatives to Medtronic's 670G MiniMed system.
By Maria Rachal • March 18, 2019 -
FDA: Avoid paclitaxel-coated PAD devices for most patients
BD Thursday joined Medtronic in pushing back against the agency's findings, saying it stands behind the safety of the Lutonix drug-coated balloon.
By Susan Kelly • Updated March 22, 2019 -
FDA greenlights device for treating carbon monoxide exposure
The De Novo-winning Thornhill device accelerates a patient’s breathing rate to get poison out of the body.
By Nick Paul Taylor • March 15, 2019 -
Fresenius gets breakthrough status for hemodialysis software
The experimental software makes recommendations to improve fluid management and thereby cut the rate of complications.
By Nick Paul Taylor • March 15, 2019 -
FDA ramps up major CDRH reorg, aiming for 'super office'
The restructuring will integrate pre and postmarket offices and shift to teams based on product type rather than life cycle. It kicks off Monday.
By Nick Paul Taylor • March 14, 2019 -
HemoSonics gets De Novo nod for POC coagulation device
The test uses ultrasound to quickly analyze blood samples at the point of care.
By Nick Paul Taylor • March 14, 2019 -
Navigating FDA's evolving device pathways: A primer
The agency is touting the biggest alterations to medtech approval processes in the decades since it began reviewing devices. Here's a roundup of the current regulatory framework and what's potentially changing.
By Meg Bryant • March 13, 2019 -
Jacob Bell/MedTech Dive
FDA qualifies test for traumatic brain injury
The OsiriX CDE test can now be used by medical device developers to identify and enroll patients in studies of TBI, which has been researched for years but has no effective treatment.
By Susan Kelly • March 13, 2019 -
NCI Director Ned Sharpless to be named FDA acting commissioner
Sharpless will succeed FDA Commissioner Scott Gottlieb in early April. He has served as director of the National Cancer Institute since October 2017.
By David Lim , Maria Rachal • Updated March 12, 2019 -
NCI Director Ned Sharpless to be FDA acting commissioner
Sharpless will succeed FDA Commissioner Scott Gottlieb in early April. He has served as director of the National Cancer Institute since October 2017.
By Maria Rachal • March 12, 2019 -
FDA digital health efforts highlighted in Trump budget
The blueprint calls for Medicare coverage for breakthrough devices.
By David Lim • March 12, 2019 -
UK to probe safety of paclitaxel cardiovascular devices
The investigation will review data linking drug-coated balloon catheters and drug-eluting stents to increased death rates, including studies of those sold by Boston Scientific, Cook Medical, C.R. Bard, Medtronic and others.
By Nick Paul Taylor • March 12, 2019 -
Latest FDA Pre-Cert working model garners tepid support
AdvaMed argued the program's promise may be compromised without legislation giving the agency more authority.
By David Lim • March 12, 2019 -
Jacob Bell/MedTech Dive
AdvaMed raises concerns with FDA's proposed De Novo model
In comments on FDA's proposed De Novo classification rule, the medical device lobby said it is concerned the framework would impose some requirements that replicate the premarket approval application review.
By Susan Kelly • March 11, 2019 -
FDA flags surgical stapler risks, plans advisory meeting
The agency alerted healthcare providers to an increasing number of medical device reports associated with use of surgical staplers, including at least 366 deaths and more than 9,000 serious injuries.
By Susan Kelly • March 11, 2019 -
CMS updates 2021 DME bidding round plans, adds new product categories
The American Association for Homecare argued addition of non-invasive ventilators to the competitive bidding program will drive companies out of business.
By David Lim • March 11, 2019 -
Bard pulls mesh implants from EU
Despite thousands of adverse event reports globally, the BD subsidiary cited the burden of generating clinical data required by new EU rules as the reason for ceasing distribution and sales.
By Nick Paul Taylor • March 8, 2019 -
FDA advisers weigh in on HPV screens
The non-voting advisory committee's recommendations aimed to broaden clinical study participation and predicate evaluation of new tests on relative performance against a clinical endpoint comparator.
By Maria Rachal • Updated March 19, 2019
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