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

Explore the Trendline➔

Medical 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

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

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

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

FDA pitches shorter grace period for UDI revision

The agency wants information submitted to the UDI database to be available to public users within one week, cutting back the 30 days companies have been given to edit their submissions for the last four years.

By Maria Rachal • 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

Information blocking rule blows past deadline

"Patients and providers have looked on with disappointment" at the delay, Health IT Now Executive Director Joel White said.

By Rebecca Pifer • Dec. 18, 2018

FDA outlines fast track vision for breakthrough devices

The agency also announced plans to establish a pathway for devices aimed at treating non-life-threatening diseases not eligible for the original program.

By David Lim • Dec. 18, 2018

FDA addresses manufacturing site changes in final guidance

The agency issued final guidance detailing when a medical device maker that plans a change in manufacturing site should submit a premarket approval application supplement.

By Susan Kelly • Dec. 17, 2018

FDA draft guidance aims to clarify X-ray radiation rules

The agency also said it plans to harmonize its performance standards with those of the International Electrotechnical Commission to simplify compliance for global manufacturers.

By Susan Kelly • Dec. 17, 2018

Texas judge rules ACA unconstitutional

The end of the Affordable Care Act would kill the medical device tax, but the ruling will almost certainly be appealed to a higher court.

By Tony Abraham • Dec. 14, 2018

FDA: Benefits beat risks with unregulated medical software

The agency reviewed safety and best practices for technologies like e-prescribing tools and mobile wellness apps, building on prior 21st Century Cures guidances addressing software as a medical device.

By Maria Rachal • Dec. 14, 2018

FDA walks back new device class definitions after industry blowback

AdvaMed and the Medical Device Manufacturers Association scored a temporary win after arguing the proposed revisions to the Class III definition could shift more devices into the high-risk category.

By David Lim • Dec. 14, 2018

Medtech industry cheers as NAFTA 2.0 edges forward

Trade groups heralded improved transparency in the recently-signed USMCA, which includes a provision that would enforce more timely reimbursement decision-making by national bodies.

By Nick Paul Taylor • Dec. 14, 2018

FDA touts progress in move toward global device audits

Participating manufacturing sites have spiked this year with 2,629 cumulatively added as of the third quarter of 2018, up from 777 at the end of 2017. 

By David Lim • Dec. 13, 2018