Medical Devices: Page 164
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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 -
Explore the Trendlineâž”
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 -
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 -
Beta Bionics, Insulet seek shake-up of insulin delivery market at ADA
Data presented at the American Diabetes Association meeting move the companies a step closer to challenging Medtronic and Tandem.
By Nick Paul Taylor • June 11, 2019 -
Stimulation device for IBS pain in children gains De Novo clearance
The non-invasive nerve stimulator is placed behind the patient’s ear to send electrical pulses to cranial nerve bundles.
By Susan Kelly • June 10, 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 -
Device interoperability, CGM for Type 2 patients among ADA 2019 standouts
More options for automated insulin dosing systems are emerging, particularly as FDA established new device classifications for interoperable pumps and glycemic controller algorithms via the De Novo pathway.
By Maria Rachal • June 10, 2019 -
Harvard's Wyss Institute receives $131M gift
The contribution comes from founder Hansjörg Wyss, the former CEO of Swiss device maker Synthes, whose vision for the institute has led to several medical breakthroughs over the past decade.
By Susan Kelly • June 10, 2019 -
Abbott and Tandem in the spotlight at diabetes meeting
Abbott is sharing details of its FreeStyle Libre 2 CGM system, and Tandem is presenting data on its automated insulin delivery system.
By Nick Paul Taylor • June 7, 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 -
Executives expect AI to transform healthcare within 3 years
Almost 90% of industry leaders are trying AI and other emerging technologies, and high percentages also believe health IT can help them identify unmet consumer needs, according to a report from Accenture.
By Nick Paul Taylor • June 6, 2019 -
Photo by Mike C. Valdivia on Unsplash. (N/A). "Mike C. Valdivia New York skyline photo" [Photograph]. Retrieved from https://unsplash.com/photos/kZokA2VTKn4.
After Varian deal, New York opens 1st proton therapy center
The East Harlem-based treatment facility struck a 10-year, $115 million service agreement with Varian Medical Systems for its ProBeam equipment in 2015.
By Nick Paul Taylor • 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 -
Apple Watch, mesh slings among new NESTcc projects
The real-world evidence hub selected 12 new test cases to evaluate its model in medical device regulatory and clinical decision-making.
By Susan Kelly • June 5, 2019
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