Medical Devices: Page 170
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1 in 5 health IT execs say malware has hit devices
Out-of-date operating systems and unavailability of patch solutions remain major cybersecurity risks for medical devices.
By Susan Kelly • Oct. 8, 2018 -
Bose self-fitting hearing aid gets FDA approval
The product is the first to be cleared by the agency that can be purchased and programmed without a doctor's prescription.
By Susan Kelly • Oct. 8, 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 -
MobileSmith
Remote patient monitoring cuts hospital admissions, ER visits, report finds
Heart disease and COPD are the most popular uses, but other less acute chronic conditions are starting to find traction with the technology, the industry and KLAS report found.
By Meg Bryant • Oct. 8, 2018 -
Blackberry announces healthcare applications for Spark platform, blockchain ledger
The tech company also announced a secure, real-time software program to assist developers of connected medical devices.
By Meg Bryant • Oct. 5, 2018 -
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CMS tweaks local coverage policy to speed access to medical devices
AdvaMed CEO Scott Whitaker said that the CMS actions are commendable, but more should be done.
By David Lim • Oct. 4, 2018 -
European Parliament passes device-friendly changes to draft HTA law
The amendments will limit the types of devices that undergo joint clinical assessments.
By Nick Paul Taylor • Oct. 4, 2018 -
Regulatory professionals working in devices paid far less than pharma peers
Reg managers in the drug industry take home around 75% more than their device counterparts.
By Nick Paul Taylor • Oct. 4, 2018 -
Baxter, Mayo team up on outpatient kidney care center
The health system and device company will open a renal care center at Mayo's campus in Jacksonville, Florida, the first initiative to come out of a broader five-year agreement announced in 2017.
By Susan Kelly • Oct. 3, 2018 -
Artificial pancreas has edge over insulin pump therapy in study
New research adds to evidence that a hybrid closed-loop insulin delivery system, also known as the artificial pancreas, offers better blood sugar control than sensor-augmented pump therapy in patients with type 1 diabetes.
By Susan Kelly • Oct. 3, 2018 -
US pays 6 times more than Germany for cardiac implants, study finds
A dramatic divergence in the prices of stents and pacemakers was the most striking finding from an analysis of what hospitals in five countries pay.
By Nick Paul Taylor • Oct. 3, 2018 -
Stryker settles foreign corrupt practice charges, makes small acquisition
The company will pay $7.8 million to settle with the Justice Department. Separately, the medical device maker said it would acquire HyperBranch Medical Technology.
By Susan Kelly • Oct. 2, 2018 -
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FDA, ECRI, device group keep up drumbeat on cybersecurity risks
The agency is launching a cybersecurity playbook for healthcare providers and said it will publish a "significant update" to its 2014 premarket guidance.
By Susan Kelly • Oct. 2, 2018 -
AdvaMed
5 themes from The MedTech Conference
Mergers and acquisitions, digital health, FDA pilot programs and Netflix's The Bleeding Edge were among the hot topics in Philadelphia.
By David Lim , Kim Dixon • Oct. 1, 2018 -
David Lim
FDA exploring potential for IMDRF Medical Device Single Review Program
The idea is for the marketing authorization for a medical device by one country to be relied on in part or in whole by other participating jurisdictions, according to FDA device chief Jeff Shuren.
By David Lim • Oct. 1, 2018 -
Ready or not, medtech braces for new EU landscape
Companies should not assume they'll get extra time to adapt, warned Vicki Anastasi, VP for medical device and diagnostics research at ICON.
By Kim Dixon • Oct. 1, 2018 -
AngioDynamics posts bigger net loss, looks to oncology
Executives said the company's two recent acquisitions signal a shift in investment to the oncology section of the business.
By Tyler Woods • Oct. 1, 2018 -
FDA finds fault with some insulin pen use directions
The agency is asking manufacturers to review their directions for use and training materials and consider adding a label warning about the need to remove both the outer and inner needle covers.
By Susan Kelly • Oct. 1, 2018 -
Doctor survey finds strong interest in new urology devices
Jefferies analysts polled 50 high-volume urologists and reported Teleflex's UroLift device accounted for 15% of procedures for an enlarged prostate while Boston Scientific's Rezum was used in 10%.
By Susan Kelly • Oct. 1, 2018 -
Hologic acquires developer of breast cancer surgery marker
The company agreed to pay $125 million for Focal Therapeutics, the latest addition to its breast health product portfolio, two months after purchasing digital imaging systems maker Faxitron Bioptics in an $85 million deal.
By Susan Kelly • Sept. 28, 2018 -
Butterfly raises $250M in bid to upend ultrasound market
The goal is to replace large, cart-based ultrasound devices that cost tens of thousands of dollars and upend a sector dominated by the likes of GE Healthcare, Philips and Fujifilm.
By Nick Paul Taylor • Sept. 28, 2018 -
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New IMDRF committee to tackle cybersecurity threats
The FDA device chief laid out takeaways from the group's Beijing meeting.
By Kim Dixon • Sept. 27, 2018 -
FDA reopens comments on decade-old stent guidance
It comes days after physicians writing in The Lancet used data from a head-to-head comparison of Medtronic's Resolute Onyx and Biotronik's ultra-thin-strut stent Orsiro to highlight the limitations of noninferiority clinical trial designs.
By Nick Paul Taylor • Sept. 27, 2018 -
Jacob Bell / BioPharma Dive
FDA reclassifies female condoms to reduce regulatory burden
The products will be categorized as Class II devices eligible for the 510(k) pathway.
By Nick Paul Taylor • Sept. 27, 2018 -
FDA expands use of Baxter bone graft to spinal fusion
Rivals Medtronic, Johnson & Johnson, Stryker and Zimmer are all competing for the bone graft substitute piece of the advanced surgery market.
By Nick Paul Taylor • Sept. 27, 2018 -
Getty / Edited by BioPharma Dive
Global device industry set to grow 5.6% a year through 2024: report
In vitro diagnostics is projected to remain as the No. 1 specialty in 2024 with annual sales of $79.6 billion and a 13.4% share of the medical device industry.
By Susan Kelly • Sept. 26, 2018
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