FDA: Page 87
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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 -
Explore the Trendline➔
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TrendlineMedical device industry continues to turn to AI
While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.
By MedTech Dive staff -
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 -
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 -
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 -
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 -
As shutdown stalls IPOs, companies mull creative paths to market
Biotechs in the process of going public are considering legal workarounds to bypass a hamstrung SEC, but the Nasdaq appears to be proceeding warily.
By Andrew Dunn • Jan. 18, 2019 -
FDA flags mortality risk of paclitaxel with stents, balloons for PAD
The letter to physicians follows a study identifying increased risk of death for patients two years after treatment for peripheral artery disease with a drug-coated balloon or drug-eluting stent.
By Susan Kelly • 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 -
No one solution to patient matching challenge, GAO says
Questions about the accuracy of digital matching tools force providers to recheck results manually, according to the government watchdog.
By Meg Bryant • Jan. 16, 2019 -
Senate Democrats question Gottlieb on FDA shutdown impact
FDA Commissioner Scott Gottlieb wrote Tuesday on Twitter the agency has returned 100 inspection staff to work to oversee high-risk medical device facilities.
By David Lim • Updated Jan. 16, 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 -
Empatica gets FDA clearance for epilepsy monitor in children
The device analyzes motion and physiological signals to detect when the wearer is having a seizure.
By Nick Paul Taylor • Jan. 11, 2019 -
FDA denies citizen petition calling for electroconvulsive therapy ban
The agency dismissed claims that the devices pose an unreasonable risk of injury.
By Nick Paul Taylor • Jan. 10, 2019 -
Grassley to zoom in on drug pricing, insurance mergers as Senate panel chair
The new Republican chairman of the Senate Finance Committee laid out his agenda for the year ahead.
By David Lim • Jan. 10, 2019 -
UK updates no-deal Brexit advice as vote on withdrawal agreement nears
Companies will need a designated individual based in the U.K. to register medical devices in the country.
By Nick Paul Taylor • Jan. 10, 2019 -
Medicare joint replacement program could succeed in more regions, Health Affairs study says
The mandatory bundled payment model first implemented in 2016 has shown some ability to cut spending without negatively affecting care quality.
By Les Masterson • Jan. 9, 2019 -
JPM19: FDA warns it won't be long before user fee funding runs dry
With no end in sight to the government shutdown, Commissioner Scott Gottlieb said medical device user fee programs have about two to three months of funding left.
By Jacob Bell • Jan. 9, 2019 -
LabCorp and Quest prepare for year of M&A as price cuts hit small labs
The laboratory testing giants expect reimbursement reductions to wipe out profits at smaller rivals, triggering a period of heavy consolidation.
By Nick Paul Taylor • Jan. 9, 2019 -
Health Affairs study calls for Medicare coverage of hearing care services
Research found that lower-income people with a hearing aid are twice as likely to experience trouble hearing compared to those with a higher income.
By David Lim • Jan. 8, 2019 -
FDA targets De Novo path to shepherd medical software through Pre-Cert
One industry lawyer questioned if the agency's most recent iteration will limit the program's potential by relying on the De Novo pathway, historically used rarely compared to its 510(k) program.
By David Lim • Jan. 8, 2019 -
CMS issues new DME strategy for patients dually-eligible for Medicare, Medicaid
The change is intended to eliminate a barrier to accessing durable medical equipment.
By Nick Paul Taylor • Jan. 8, 2019
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