FDA: Page 84
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FDA ends alternative reporting program, pledges to make MAUDE user friendly
The agency disclosed more than 6 million medical device adverse event reports were filed under the controversial system since 1997.
By David Lim • June 24, 2019 -
Label should warn patients of paclitaxel device mortality signal, FDA panel says
The advisory committee struggled through the two-day meeting evaluating the safety of the devices due to incomplete data. Members agreed more data is needed but differed on the method the agency should use to collect it.
By David Lim • June 21, 2019 -
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 -
SEC ends Misonix foreign corruption probe without action
The maker of ultrasonic devices triggered the investigation in 2016 when it contacted the SEC with information about the business practices of its Chinese distributor.
By Nick Paul Taylor • June 21, 2019 -
FDA safety panel pans lack of paclitaxel device postmarket data on Day 1
The agency's Circulatory System Devices Panel Advisory Committee agreed Wednesday there is a mortality signal associated with paclitaxel-coated balloons and paclitaxel-eluting stents.
By David Lim • June 20, 2019 -
OIG finds Medicare overpaid $125M for radiation services
The inspector general wants CMS to implement billing requirements and other changes intended to prevent further unnecessary payments.
By Nick Paul Taylor • June 20, 2019 -
Philips gets FDA approval for over-the-counter defibrillators
The devices were previously cleared for sale in the U.S. via the 510(k) pathway but now need PMA approval.
By Nick Paul Taylor • June 20, 2019 -
Foam to stop abdominal bleeding gets FDA breakthrough nod
Gel-e's Life Foam product is designed to stabilize the patient in battlefield conditions or in a traumatic accident where life-threatening internal bleeding occurs and immediate urgent care isn't available.
By Susan Kelly • June 19, 2019 -
Swiss notified body to exit sector, heightening EU capacity fears
QS Zürich’s withdrawal will leave Switzerland with one medtech notified body, as new rules for the bloc near.
By Nick Paul Taylor • June 19, 2019 -
FDA safety panel to weigh paclitaxel-coated stents, balloons
The advisory panel, which will meet for two days starting Wednesday, will examine mortality and causality issues surrounding the paclitaxel-coated devices sold by BD, Medtronic, Cook Medical, Philips and Boston Scientific.
By David Lim , Maria Rachal • Updated June 18, 2019 -
As CMS decision on TAVR looms, a push for broader access
Proposed agency rules would lower the bar for hospitals performing the less invasive heart procedure, but would also raise the eligibility requirements to offer the treatment.
By Nick Paul Taylor • June 18, 2019 -
Health Canada seeks advice on device action plan next steps
The agency is asking for public comments on proposed rule changes that would require device makers to provide post-market safety information about products.
By Susan Kelly • June 17, 2019 -
Lloyd's exits notified body services, leaving UK with 3
The withdrawal comes as Europe faces major concerns about capacity ahead of the new MDR and IVD regs.
By Nick Paul Taylor • June 14, 2019 -
Kendall Davis/MedTech Dive
DHS warns of severe security flaw with BD infusion pumps
The department gave the BD Alaris Gateway Workstation vulnerability the maximum score on a standard grading scale.
By Nick Paul Taylor • June 14, 2019 -
FDA issues draft advice on biotin interference with diagnostic testing
A 2017 agency safety communication reported a patient dying after high levels of biotin interference resulted in falsely low troponin results. Troponin tests are often used to detect heart attacks.
By David Lim • June 13, 2019 -
AMA adopts measures to shape development, uptake of AI systems in healthcare
The policies seek to ensure developers of AI, not physicians, are liable for medical errors involving the technologies.
By Nick Paul Taylor • June 13, 2019 -
FDA posts draft guidance on testing of reproductive devices
The agency details how developers and manufacturers of assisted reproduction technology devices can perform mouse embryo assays to assess embryotoxicity.
By Nick Paul Taylor • June 13, 2019 -
OIG estimates Medicare overpaid $269M for sleep studies
OIG thinks the problems occurred because CMS failed to provide the oversight needed to stop payments for noncompliant claims.
By Nick Paul Taylor • June 13, 2019 -
Germany, Ireland push EU to assess device regs preparedness
The delegations think a significant reduction in notified bodies is likely but hope to avoid delaying implementation "unless absolutely necessary."
By Nick Paul Taylor • June 12, 2019 -
EU names UDI issuers in move to new medtech regs
Four organizations will support implementation of UDI systems under the new EU Medical Device Regulation and In Vitro Diagnostics Regulation.
By Susan Kelly • June 11, 2019 -
Quest, LabCorp breach stirs questions of cybersecurity risk from outside vendors
The breach could result in new regulations and rules governing how U.S. companies select and assess their vendors, according to Moody's.
By Rebecca Pifer Parduhn • Updated June 11, 2019 -
Edwin Lopez/MedTech Dive
Medtech avoids tariff blow as US, Mexico reach deal
President Donald Trump late Friday called off plans for a 5% tariff set to go into effect today on imports from Mexico.
By Susan Kelly • June 10, 2019 -
Kendall Davis/MedTech Dive
Deep DiveInside Quest Diagnostics, LabCorp's supply chain breach
The intrusion happened inside the American Medical Collection Agency, but responsibility is shared through its partner ecosystem.
By Samantha Schwartz • June 6, 2019 -
FDA approves DT MedTech's total ankle replacement implant
The company will aim to compete with Stryker and Zimmer Biomet.
By Nick Paul Taylor • June 6, 2019 -
House committee passes 6% increase in FDA funding
The committee wants one FDA priority, the Transform Medical Device Safety, Cybersecurity, Review, and Innovation initiative, to make do with the same level of funding as it received in fiscal 2019.
By Nick Paul Taylor • June 5, 2019 -
Device industry praises FDA AI/ML framework, asks for Class III software inclusion
AdvaMed and the Combination Products Coalition applauded the agency's work on a regulatory approach for the emerging technology, but gave a slew of recommendations for FDA to consider as it develops a potential draft guidance.
By David Lim • June 4, 2019
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