FDA: Page 92
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FDA targets late 2019 for hearing aid proposed rule
The plan comes two weeks after Bose won clearance to sell the first self-fitting hearing aid that can be programmed without the help of a healthcare provider.
By David Lim • Oct. 18, 2018 -
FDA floats changes to cybersecurity guidance to strengthen safeguards
Proposals include creation of lists of all hardware and software components used in a device that could be vulnerable to attack.
By Nick Paul Taylor • Oct. 18, 2018 -
Explore the Trendline➔
Sitthiphong via Getty Images
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 -
FDA boosts medical device cybersecurity coordination with Homeland Security
The DHS Office of Cybersecurity and Communications and FDA's device center will increase information sharing of potential and confirmed device vulnerabilities and threats.
By David Lim • Oct. 16, 2018 -
Anthem shells out $16M to settle biggest health data breach in history
The fund will pay for four years of credit monitoring and all other claims, costs and fees for affected individuals, according to the settlement.
By Rebecca Pifer • Oct. 16, 2018 -
Endologix recalls cardiac implants amid ongoing rupture risk
The Class I recall stems from reports of some devices failing to divert blood away from aneurysms.
By Nick Paul Taylor • Oct. 16, 2018 -
Blue Button 2.0 doubles developers to 1,200, but beneficiary uptake tiny
CMS Administrator Seema Verma tells MedTech Dive that 11 organizations have "production apps" in place using live data.
By David Lim • Oct. 15, 2018 -
National Academy of Medicine argues barriers to interoperability are organizational, not technical
An extensive report outlining challenges and recommendation for data sharing comes as the industry awaits a rule from HHS that attempts to thwart information blocking.
By Rebecca Pifer • Oct. 15, 2018 -
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 -
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 -
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 • 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, 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 -
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
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