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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 -
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 -
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 -
Hospitals see 'modest' 3% savings using Medicare joint replacement model, study finds
Those participating didn't see a significant difference in complications or percentage of procedures among high-risk patients, according to the report in the New England Journal of Medicine.
By Les Masterson • Jan. 4, 2019 -
5 scariest health data breaches of 2018
They weren't all the biggest, but each shed light on how the industry isn't improving quickly on the cybersecurity front.
By Tony Abraham • Jan. 4, 2019 -
Booz Allen gives FDA device center progress high marks
Agency staff said better access to information about prior regulatory decisions of similar devices and more structured electronic submissions from manufacturers would help improve review efficiency.
By David Lim • Jan. 4, 2019 -
OIG finds Pacific Medical received unallowable Medicare payments
The oversight body wants the provider of orthotic braces to refund almost $250,000.
By Nick Paul Taylor • Jan. 4, 2019 -
HL7 releases latest FHIR version
The new iteration brings normative status, meaning future changes will be backward compatible.
By Meg Bryant • Jan. 3, 2019 -
Deep Dive
What's in a connected medical device? Cybersecurity regulators want to know
FDA could require device makers to publicize a software bill of materials as early as the premarket application process to more quickly identify vulnerabilities in the event of a cyberattack.
By Meg Bryant • Jan. 3, 2019 -
HHS issues voluntary guidelines amid rise of cyberattacks
The department, together with an industry-led task force, compiled best practices on how to protect patients and health systems from growing cyberthreats.
By Samantha Liss • Jan. 2, 2019 -
CMS sets user fee increase for CLIA-certified labs
User fees will go up 20%, the first increase in two decades, to cover general program administration costs.
By Susan Kelly • Dec. 31, 2018 -
FDA reclassifies some electroconvulsive devices in final order
The agency has given manufacturers of devices not covered by the reclassification 90 days to file PMAs.
By Nick Paul Taylor • Dec. 23, 2018 -
Brian Tucker/MedTech Dive
Regulatory makeovers and international game changers: MedTech Dive's top stories of 2018
Hard looks at cybersecurity and digital health's hot streak also left their mark on the year.
By Maria Rachal • Dec. 22, 2018 -
Government shutdown partially shutters FDA
Hitting its 12th day, 7,053 employees, or more than 40% of the agency's workforce, is furloughed. Commissioner Scott Gottlieb said new guidance on ongoing activities will come later Wednesday.
By David Lim • Updated Jan. 2, 2019 -
Bayer, FDA lengthen Essure postmarketing study to 5 years
The German pharma announced in July it would no longer sell the birth control implant in the U.S. due to falling sales.
By David Lim • Dec. 21, 2018 -
Health Canada unveils plan to improve medical device safety
The action plan follows an extensive journalistic investigation which uncovered deficient testing of medical devices and underreporting of injuries and deaths resulting from implants.
By Susan Kelly • Dec. 21, 2018 -
Allergan loses CE mark for textured breast implants, opening EU market
FDA plans to hold a meeting on breast implant safety in 2019 as it "monitors the known risks associated with breast implants, such as capsular contracture, implant rupture and breast implant-associated anaplastic large cell lymphoma."
By David Lim • Dec. 20, 2018 -
UK regulator puts brakes on Thermo Fisher-Gatan deal
The Competition and Markets Authority said Thermo Fisher’s proposed $925 million acquisition of Roper Technologies' Gatan business could raise prices or lower quality for customers using specialized microscopes.
By Susan Kelly • Dec. 20, 2018
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