FDA: Page 98
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FDA monitoring 11 device firms for shortages in aftermath of Hurricane Michael
In addition, HHS has moved 400 medical and public health professionals and medical equipment into impacted areas.
By David Lim • Oct. 12, 2018 -
Jacob Bell/MedTech Dive
FDA warns of Medtronic device cybersecurity risk
The alert follows discovery that hackers could adjust the settings of cardiac devices. While the FDA has not received reports of patient harm, Medtronic has disabled the online software update.
By Nick Paul Taylor • Oct. 12, 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 -
Congress expands Sunshine payment reporting rules
A bill expected to be signed by the president requires companies report payments to physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists and certified nurse-midwives.
By Nick Paul Taylor • Oct. 11, 2018 -
Top Democrats question FDA Pre-Cert program safety, statutory authority
Concern that the agency may be overstepping its authority echoes comments submitted by the Clinical Decision Support Coalition.
By David Lim • Oct. 11, 2018 -
Deep Dive
FDA takes aim at lack of pediatric devices
"Funding is a huge challenge because of the inherently small market," Reed McCarty, co-founder and partner at SandBox Medical, told MedTech Dive.
By Meg Bryant • Oct. 8, 2018 -
Bose self-fitting hearing aid gets FDA approval
The product is the first to be cleared by the agency that can be purchased and programmed without a doctor's prescription.
By Susan Kelly • Oct. 8, 2018 -
UK recalls 58K pregnancy tests after false positive reports
The digital displays of some devices erroneously told users they were pregnant.
By Nick Paul Taylor • Oct. 5, 2018 -
CMS tweaks local coverage policy to speed access to medical devices
AdvaMed CEO Scott Whitaker said that the CMS actions are commendable, but more should be done.
By David Lim • Oct. 4, 2018 -
Survey exposes lack of understanding of EU device regulations
Most companies are unsure of the full implications of the soon-to-be-enforced rules.
By Nick Paul Taylor • Oct. 4, 2018 -
European Parliament passes device-friendly changes to draft HTA law
The amendments will limit the types of devices that undergo joint clinical assessments.
By Nick Paul Taylor • Oct. 4, 2018 -
Regulatory professionals working in devices paid far less than pharma peers
Reg managers in the drug industry take home around 75% more than their device counterparts.
By Nick Paul Taylor • Oct. 4, 2018 -
Medical device companies see upside in NAFTA 2.0
The deal mandates cross-border recognition of quality audits and publication of information about how each country sets reimbursement rates. The changes could lessen the non-tariff barriers faced by U.S. companies.
By Nick Paul Taylor • Oct. 3, 2018 -
US pays 6 times more than Germany for cardiac implants, study finds
A dramatic divergence in the prices of stents and pacemakers was the most striking finding from an analysis of what hospitals in five countries pay.
By Nick Paul Taylor • Oct. 3, 2018 -
Patient-matching tools nowhere near perfect, Pew says
A report recommends clarifying government funding restrictions for unique identifiers, agreeing on standardized demographics, assessing privacy ramifications and researching referential matching using third-party data.
By Rebecca Pifer Parduhn • Oct. 2, 2018 -
FDA, ECRI, device group keep up drumbeat on cybersecurity risks
The agency is launching a cybersecurity playbook for healthcare providers and said it will publish a "significant update" to its 2014 premarket guidance.
By Susan Kelly • Oct. 2, 2018 -
Stryker settles foreign corrupt practice charges, makes small acquisition
The company will pay $7.8 million to settle with the Justice Department. Separately, the medical device maker said it would acquire HyperBranch Medical Technology.
By Susan Kelly • Oct. 2, 2018 -
FDA starts 510(k) pilot in bid to shorten reviews
The effort will test the expanded criteria for Special 510(k) Program filings.
By Nick Paul Taylor • Oct. 2, 2018 -
5 themes from The MedTech Conference
Mergers and acquisitions, digital health, FDA pilot programs and Netflix's The Bleeding Edge were among the hot topics in Philadelphia.
By David Lim , Kim Dixon • Oct. 1, 2018 -
FDA exploring potential for IMDRF Medical Device Single Review Program
The idea is for the marketing authorization for a medical device by one country to be relied on in part or in whole by other participating jurisdictions, according to FDA device chief Jeff Shuren.
By David Lim • Oct. 1, 2018 -
FDA clears NGS test to detect residual blood cancer cells
Adaptive Biotechnologies' assay detects and monitors minimal residual disease in multiple myeloma and B-cell acute lymphoblastic leukemia patients.
By Susan Kelly • Oct. 1, 2018 -
FDA finds fault with some insulin pen use directions
The agency is asking manufacturers to review their directions for use and training materials and consider adding a label warning about the need to remove both the outer and inner needle covers.
By Susan Kelly • Oct. 1, 2018 -
FDA floats changes to Special 510(k) program
The update will expand use of the program to a wider range of device modifications.
By Nick Paul Taylor • Sept. 28, 2018 -
New IMDRF committee to tackle cybersecurity threats
The FDA device chief laid out takeaways from the group's Beijing meeting.
By Kim Dixon • Sept. 27, 2018 -
Shuren: Funds needed to launch FDA Center of Excellence for Digital Health
The device center head's warning comes as Commissioner Scott Gottlieb stresses the importance that Congress keep investing in the FDA.
By David Lim • Sept. 27, 2018 -
FDA reopens comments on decade-old stent guidance
It comes days after physicians writing in The Lancet used data from a head-to-head comparison of Medtronic's Resolute Onyx and Biotronik's ultra-thin-strut stent Orsiro to highlight the limitations of noninferiority clinical trial designs.
By Nick Paul Taylor • Sept. 27, 2018
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