Medical Devices: Page 172
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FDA rolls out plan to reduce third party 510(k) re-reviews
Commissioner Scott Gottlieb said outsourcing review of low-risk devices can enable FDA to focus more resources on high-risk and more complex devices.
By David Lim • Sept. 14, 2018 -
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AngioDynamics to buy RadiaDyne for radiotherapy devices
RadiaDyne thinks AngioDynamics' commercial infrastructure will help it to grow sales beyond the $6 million achieved over the past 12 months.
By Nick Paul Taylor • Sept. 14, 2018 -
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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 delays Inbrija drug-device combo
Regulators need more time to assess the biotech's Parkinson's drug-device combination, adding another layer of complexity to manufacturing and approval processes.
By Jacob Bell • Sept. 13, 2018 -
J&J buys EIT for 3D-printed titanium spinal implants
The devices are designed to increase the number of surgeries that are successful the first time.
By Nick Paul Taylor • Sept. 13, 2018 -
Apple
New Apple Watch adds FDA-cleared ECG application
Agency officials touted the clearance as heralding a new age of digital health. Still, risks include false positives and negatives, which could lead to unneeded procedures or misdiagnosis.
By David Lim • Sept. 12, 2018 -
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FDA advised to step up device cybersecurity checks premarket
In response to the watchdog report, FDA said it is already working on implementing the recommendations.
By Susan Kelly • Sept. 12, 2018 -
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Medtronic plants hit with FDA warning letters
The notices relate to two facilities that made recalled implantable cardioverter-defibrillators.
By Nick Paul Taylor • Sept. 12, 2018 -
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Cook resolves FDA warning letter that slammed quality processes
The close-out letter follows four years of work to improve quality management.
By Nick Paul Taylor • Sept. 12, 2018 -
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Medtronic to study one month of DAPT in high-bleeding-risk patients
The study will look at whether a shortened dual antiplatelet therapy regimen is enough to minimize stent thrombosis and other complications in patients.
By Susan Kelly • Sept. 11, 2018 -
AliveCor snags FDA breakthrough device status for bloodless hyperkalemia test
The agency has granted the designation, which fast tracks review, to 83 devices as of the end of July.
By David Lim • Sept. 11, 2018 -
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Stryker buys surgical lighting company for $190M
Photonics and intracavity lighting company Invuity is the latest acquisition in Stryker's ongoing purchasing spree.
By Rebecca Pifer • Sept. 11, 2018 -
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FDA raises concerns about feeding tube misconnections
The agency is recommending hospitals and clinicians use devices with connectors that meet International Organization for Standardization requirements.
By Susan Kelly • Sept. 10, 2018 -
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Becton Dickinson sells bioprocessing business to Thermo Fisher
Divesting the unit will allow Becton to better focus its life sciences division on disease and therapy research and clinical diagnostics.
By Susan Kelly • Sept. 10, 2018 -
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Bundled payment model cuts joint replacement costs in study
The evaluation of the Comprehensive Care for Joint Replacement program, prepared for CMS, found the drop in costs was primarily due to reduced use of post-acute care institutions.
By Susan Kelly • Sept. 10, 2018 -
FDA clears new version of Baxter bone graft substitute
Johnson & Johnson's DePuy Synthes unit, Medtronic and Stryker make competing synthetic bone grafts.
By Susan Kelly • Sept. 7, 2018 -
Livongo adds continuous glucose data via Abbott's FreeStyle Libre
Gathering continuous glucose data is intended to help diabetes patients and their doctors personalize treatment and improve decisions about care.
By Susan Kelly • Sept. 7, 2018 -
As EpiPen struggles, Walgreens, Kaleo ink Auvi-Q partnership
Auvi-Q will now be offered at Walgreens' roughly 9,800 locations at no cost for commercially insured patients eligible for Kaleo's patient support programs.
By Jacob Bell • Sept. 7, 2018 -
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BTG acquires Irish device maker Novate Medical
The $20 million cash deal could reach $150 million if certain business milestones are met.
By David Lim • Sept. 7, 2018 -
Boston Scientific inks $600M Augmenix buyout
The focus of the deal is a device to reduce the side effects of prostate cancer radiotherapy.
By Nick Paul Taylor • Sept. 7, 2018 -
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Life science CEOs see future in technology, disruption
A KPMG survey also showed that cybersecurity remains a major pain point, with 33% of executives calling it the top risk to their organization's growth.
By Meg Bryant • Sept. 6, 2018 -
MRI-compatible cardiac rhythm implants cost hospitals $400M a year: report
The analysis questions the value of paying extra for premium cardiac rhythm management devices.
By Nick Paul Taylor • Sept. 6, 2018 -
Watchdog slams Veterans Health Administration on device sterility
GAO investigators found failings in the oversight of reusable medical equipment cleaning.
By Nick Paul Taylor • Sept. 6, 2018 -
Gottlieb: UnitedHealth, CareFirst sign onto FDA pilot aiming to speed device coverage
The FDA chief also outlined new programs including "QUiK Review" aimed at cutting review times for low-risk 510(k) submissions "by as much as 30%."
By David Lim • Sept. 5, 2018 -
Developing afib after valve implant raises risks, study finds
Just a third of patients who developed atrial fibrillation after a transcatheter aortic valve replacement procedure got oral anticoagulation medication at discharge, according to a Duke University study.
By Susan Kelly • Sept. 5, 2018 -
Aetna to cover Abbott's non-opioid pain implant Proclaim
The decision opens up a potential market of 22 million people for the neurostimulation device.
By Nick Paul Taylor • Sept. 5, 2018
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