Medical Devices: Page 147
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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 -
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 -
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 -
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FDA posts draft guidance on testing of reproductive devices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 -
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 -
Deep Dive
Inside 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 -
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 -
Donor lung preservation system gains expanded indication
The approval allows TransMedics' lung preservation technology to be used for donor lungs initially deemed unacceptable for transplant due to the limitations of traditional cold storage.
By Susan Kelly • June 4, 2019 -
OIG issues alert on genetic testing scam
Scammers are trying to get personal information from Medicare beneficiaries by offering genetic testing through telemarketing calls, booths at public events, health fairs and door-to-door visits.
By Susan Kelly • June 4, 2019 -
UK regulators discourage use of paclitaxel devices to treat intermittent claudication
The notice is the latest signal of caution surrounding paclitaxel-eluting stents and coated balloons, coming two weeks before FDA is set to scrutinize the class of devices in a two-day meeting.
By Maria Rachal • June 4, 2019
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