Medical Devices: Page 155
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Final TAVR Medicare decision gets thumbs up from Edwards, Medtronic
The new policy eases volume requirements for hospitals and physicians to begin transcatheter aortic valve replacement programs but increases the number of valve procedures necessary to maintain a program.
By Susan Kelly • June 24, 2019 -
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 -
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 -
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 -
FDA
NIH’s Collins highlights progress on 3D printed human organs
Researchers at Rice University found a way to create an open-source bioprinting technology that grows soft hydrogel scaffolds one layer at a time.
By Susan Kelly • June 21, 2019 -
Glaukos strikes deal to buy retinal drug delivery company
The takeover will give Glaukos ownership of micro-invasive, sustained-released, bio-erodible drug delivery platforms.
By Nick Paul Taylor • June 21, 2019 -
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 -
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 -
Bursting balloon catheters prompt Cook Medical recall
The action comes less than a year after the Bloomington, Indiana-based device maker resolved an FDA warning letter faulting its quality management system.
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 approves cochlear implant designed for MRI
The implant is designed for safe access to magnetic resonance imaging scans and doesn’t require a head wrap or removal of the device’s internal magnet.
By Susan Kelly • June 18, 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 -
FDA ‘white hat’ hacking tools may combat medical misinformation
Cybersecurity techniques the agency uses to protect medical devices could also help fight the spread of medical misinformation, former FDA Commissioner Robert Califf wrote in a journal.
By Susan Kelly • June 17, 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 -
SaMD will increase device innovation: Fitch
FDA’s proposed regulatory framework will allow medical technology manufacturers to incorporate AI and machine learning while improving software monitoring.
By Susan Kelly • June 17, 2019 -
Margin for error ‘almost zero’ in testing pediatric devices
As barriers dog pediatric device development, one FDA-backed group is trying a different path.
By Maria Rachal • June 14, 2019 -
Many in need of knee cartilage repair excluded from studies, researchers say
More inclusive clinical trial designs would better reflect the broader population needing treatment, study authors say.
By Susan Kelly • June 14, 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 -
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 -
Device maker to pay $15M to resolve false claims allegations, ‘silent recall’
ACell failed to report a product recall to FDA and billed Medicare for indications sales reps knew were not backed by clinical data to receive inflated reimbursement, the Department of Justice said.
By David Lim • June 12, 2019 -
China leads world in digital health adoption, Philips survey finds
Healthcare professionals in China are more likely to recommend patients use digital health technologies than their peers in the West.
By Nick Paul Taylor • June 12, 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
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