FDA: Page 94
-
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 -
Explore the Trendline➔
Permission granted by Boston Scientific
TrendlineNew medical devices are reshaping the medtech industry
From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.
By MedTech Dive staff -
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 -
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 -
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 Parduhn • 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 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 -
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 -
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 -
FDA adds information on device BLAs to user fee guidance
The revised document features additional information on the fees for device biologics license applications.
By Nick Paul Taylor • Dec. 13, 2018 -
FDA rates GE ventilator safety guard recall as Class I event
The recall was triggered after the tech giant discovered the device has the potential to disconnect from the patient's breathing circuit.
By Nick Paul Taylor • Dec. 13, 2018 -
Retrieved from Apple on September 12, 2018
Apple EKG, artificial iris among FDA 2018 device decisions
De Novos are on the rise, but both premarket approvals and 510(k)s appear to be slightly down from 2017, according to nearly year-end data from FDA.
By Meg Bryant • Dec. 12, 2018 -
Australia plans reclassification of medical software to better reflect risk
The country's regulator thinks the current system underestimates the threat posed by software as a medical device.
By Nick Paul Taylor • Dec. 12, 2018 -
Lawmakers impatient for ONC interoperability rule
"It is hard to explain to people that Congress provided the tools necessary for doctors and patients to better coordinate their care through the sharing of patient data, but nothing has changed," Rep. Michael Burgess, R-Texas, said at a House health subcommittee hearing.
By Rebecca Pifer Parduhn • Dec. 11, 2018 -
Thermo Fisher gets FDA nod for plazomicin immunoassay
The antibiotic, marketed as Zemdri, is used to treat patients with complicated urinary tract infections.
By Susan Kelly • Dec. 11, 2018 -
Duodenoscope studies find higher-than-expected contamination rate, FDA says
Across studies run by Olympus, Fujifilm and Pentax, 6% of sampled devices were contaminated with microorganisms including pathogenic strains such as E. coli.
By Nick Paul Taylor • Dec. 11, 2018
Previous
