FDA: Page 102
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House repeals medical device tax, Senate path muddied
The device industry has successfully put off the tax, one of several imposed on industry in the Affordable Care Act, for years.
By David Lim • Updated July 24, 2018 -
5 key parts of the FDA Medical Device Safety Action Plan
The ambitious proposal focuses on a total lifecycle approach to device safety.
By Meg Bryant • July 23, 2018 -
Explore the Trendlineâž”
Courtesy of Intuitive Surgical
TrendlineTop 5 stories from MedTech Dive
From the top medtech trends to watch in 2026 to haphazard layoffs at the Food and Drug Administration and the evolving use of AI in the medtech sector, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
Deep Dive
Pharma and AI? Let's try augmented intelligence first
Pharma will need collaborations and in-house capabilities to successfully use AI across drug development.
By Lisa LaMotta • July 23, 2018 -
Bayer to stop selling Essure birth control implant in US
The German pharma said it stands by the product's safety, despite thousands of lawsuits claiming it caused harm.
By Susan Kelly • July 23, 2018 -
Maryland broadens hospital price transparency initiative
The Maryland Health Care Commission website helps consumers compare prices for common non-emergency procedures.
By Tony Abraham • July 20, 2018 -
Industry seeks clarity on latest FDA Pre-Cert working model
A software coalition questioned the agency's statutory authority to run a pilot test in 2019.
By David Lim • July 19, 2018 -
FDA finalizes guidance on use of EHRs in clinical trials
Industry groups including AdvaMed and BIO were broadly supportive of an earlier draft.
By Nick Paul Taylor • July 19, 2018 -
FDA reiterates concern about off-label use of bile-duct stents
In 2016, Abbott won a whistleblower lawsuit by a former sales representative who accused the company of off-label marketing of bile-duct stents to treat peripheral artery disease.
By Susan Kelly • July 18, 2018 -
Calls to revamp physician self-referral law grow louder
Device makers, lab, imaging and hospital companies all back changes to the Stark law, arguing it impedes the move toward alternative payment and value-based care.
By Susan Kelly • July 18, 2018 -
Jacob Bell/MedTech Dive
FDA approves Stryker flow diverter, creating competition for Medtronic
The device gives surgeons another way to treat unruptured intracranial aneurysms.
By Nick Paul Taylor • July 18, 2018 -
Device industry lobbies FDA on combo product classification
AdvaMed argues the agency too often concludes a product’s primary mode of action is that of a drug or biologic rather than a device.
By Susan Kelly • July 17, 2018 -
HHS kills clinical guidelines website, cites budget cuts
The National Guideline Clearinghouse, a 20-year-old archive of best medical practices, was shut down this week. On Tuesday, the nonprofit that maintained the site said it will keep a fee-based version to launch in the fall.
By Rebecca Pifer Parduhn • July 17, 2018 -
Quest study contends value-based care adoption has slowed
The survey found that 57% of health plan executives believe physicians do not have the necessary tools to succeed in a value-based system, up from 45% last year.
By David Lim • July 17, 2018 -
Abbott device to repair leaky heart valves approved
Artificial heart valve pioneer Edwards LifeSciences is developing treatments for mitral regurgitation that would compete with Abbott's MitraClip.
By Susan Kelly • July 16, 2018 -
CMS targets data gaps in setting lab payments
The American Clinical Laboratory Association said it "will urge Congress as well as CMS to address significant shortfalls in the data collection process that jeopardize care for the most vulnerable seniors."
By Susan Kelly • July 16, 2018 -
Deep Dive
Transition clock ticking on new EU device regs
"It's a problem because how do you comply with a new standard when you don't know what the standard is?" said AdvaMed's Joe Gatewood.
By Meg Bryant • July 16, 2018 -
More insurers using outcomes-based deals with drug, device companies
Heart, infectious diseases and oncology are the top three therapeutic areas where the contracts are used, according to an Avalere survey.
By Meg Bryant • July 13, 2018 -
Medtronic gets expanded FDA label for cardiac pacing lead
The label expansion covers use of the device in His bundle pacing.
By Nick Paul Taylor • July 13, 2018 -
Medtech spared as US unveils tariffs on imports worth $200B
Most medical devices will not be affected by the proposed 10% levy.
By Nick Paul Taylor • July 13, 2018 -
CMS proposes putting Durable Medical Equipment bidding on pause
Administrator Seema Verma said the agency's ideas will result in a more competitive bidding program, and an industry group initially seems pleased with the proposals.
By David Lim • July 12, 2018 -
Medtronic gets FDA approval for less-invasive LVAD
The regulatory nod gives the device giant an advantage over rival Abbott.
By Nick Paul Taylor • July 12, 2018 -
Medtronic, UnitedHealthcare say value-based pact cut diabetes costs
The biggest U.S. payer and largest medical device company saw encouraging results in the program's first year.
By Susan Kelly • July 11, 2018 -
Gottlieb: Investment into leveraging RWD will benefit device, drug safety
Allowing FDA to use de-identified EHR clinical medical information would boost safety monitoring and shift more development to a post-market setting, the FDA commissioner said.
By David Lim • July 11, 2018 -
New body to improve patient EHR matching advised by experts
Advisers convened by Pew want the entity to create best practices and standards to better link patients to health records.
By Nick Paul Taylor • July 11, 2018 -
Better cybersecurity safeguards urged for medical devices, EHRs
A congressional panel issued a request for information on how to improve cybersecurity in the medical device sector, amid concerns that older “legacy” technologies may be more vulnerable to security threats than their modern counterparts.
By Susan Kelly • July 10, 2018
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