Medical Devices: Page 150
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Paclitaxel device makers roll out revised labels, fresh safety analyses
Philips and BD highlighted independent analyses published this week defending their drug-coated balloons as manufacturers update product labels acknowledging a late mortality signal in peripheral artery disease patients.
By Maria Rachal • Oct. 3, 2019 -
IMDRF cybersecurity guidance favors total product life cycle approach
The International Medical Device Regulators Forum's draft mirrors U.S. regulators' support for a total product life cycle strategy, but does not include a tiered approach to categorizing risk laid out by FDA last year.
By Nick Paul Taylor • Oct. 3, 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 -
Some Class I devices could get 4 extra years to comply with EU MDR
The European Union's Medical Device Coordinating Group met with medical device stakeholders Monday in advance of an expected vote on a corrigendum to amend or modify some parts of major upcoming EU regulatory changes.
By Dana Elfin • Oct. 2, 2019 -
DME industry pans CMS' gap-fill proposal, but agrees current system is "fundamentally flawed"
CMS' proposed framework to compare new technology to older items is not sufficiently fleshed out and isn't transparent enough, the American Association for Homecare said.
By David Lim • Oct. 2, 2019 -
Third-party software vulnerability could endanger medical devices, FDA and DHS warn
The alerts expand the list of vendors whose operating systems could be exploited due to vulnerabilities known as URGENT/11. Medical devices affected include an infusion pump and an anesthesia machine, FDA said Tuesday.
By Susan Kelly • Oct. 2, 2019 -
Researchers automate EHR analysis for postmarket safety surveillance
Stanford researchers found an automated system extracted the vast majority of reports of complications and pain in electronic health records for hip replacement patients.
By Nick Paul Taylor • Oct. 2, 2019 -
Stryker inks Conformis deal to develop custom knee surgery instruments
The deal could give Stryker technology to rival devices used by Johnson & Johnson, Smith & Nephew and Zimmer Biomet.
By Nick Paul Taylor • Oct. 2, 2019 -
Robotics, navigation systems create buzz at spine meeting
Medtronic, NuVasive and Globus Medical showed off robotic applications at the North American Spine Society gathering in Chicago. "[A]doption of more advanced platforms is not an if, but a when," Jefferies analysts wrote.
By Susan Kelly • Oct. 1, 2019 -
Sterigenics abandons effort to reopen Willowbrook ethylene oxide sterilization facilities
The company behind the major medical device sterilization plant said it is "actively taking steps to ensure customer and patient needs continue to be met by our other facilities."
By David Lim • Sept. 30, 2019 -
Edwards shows improved quality of life, durability of TAVR systems in trio of studies
Among other data presented over the weekend at TCT, Boston Scientific's in-development Acurate Neo TAVR system failed to meet a non-inferiority goal on safety and efficacy when compared to Edwards' Sapien 3.
By Susan Kelly • Sept. 30, 2019 -
Abbott's MitraClip outperforms medical therapy in study at 3 years
In addition, a group of patients that began the study on medical therapy and crossed over to the MitraClip at two years saw benefits matching those who received the device from the start.
By Susan Kelly • Sept. 30, 2019 -
Implanted metal devices, dental amalgam to go under FDA's microscope
Citing the "growing body of evidence" suggesting some patients have inflammatory reactions and tissue changes to metal-containing implants, the agency announced a November advisory panel to discuss the topic.
By Maria Rachal • Sept. 30, 2019 -
Australia enforces new regs on all breast implant makers, suspends some devices
Even with Allergan's most controversial implants off the market, regulators opted to remove about 13% of Australia's available breast implant supply and enact new communication requirements on all remaining sellers.
By Maria Rachal • Sept. 27, 2019 -
Medtronic, Boston Scientific share data on stents with short-course antiplatelet therapy
The clinical trials provide data supporting the use of shorter regimens in coronary stent patients.
By Nick Paul Taylor • Sept. 27, 2019 -
TÃœV Rheinland designated as notified body under MDR
The approval by European authorities gives medical device companies another entity to turn to as they scramble to get ready for the 2020 implementation.
By Nick Paul Taylor • Sept. 27, 2019 -
FDA revises clinical decision support software draft after industry blowback
The decision to revise the draft guidance comes after feedback on the 2017 version asked the agency to reconsider its approach, Bakul Patel, FDA's director for digital health, told MedTech Dive.
By David Lim • Sept. 26, 2019 -
BD picks new CEO
COO Thomas Polen, who led the major acquisitions of C.R. Bard and CareFusion, will replace retiring chief executive of eight years Vincent Forlenza on Jan. 28, 2020.
By Maria Rachal • Sept. 26, 2019 -
Device chief says FDA could be open to making breakthrough designations public
The number of breakthrough designations has doubled every year since the program's 2016 inception, and "you're going to start seeing this [number of approvals] steamroll," FDA's Jeff Shuren said at The MedTech Conference.
By Dana Elfin • Sept. 26, 2019 -
Boston Scientific and Medtronic devices match on safety in 3-year TAVR trial
The Boston Scientific-backed trial found a similar rate of all-cause mortality between the two systems. Boston's device beat Medtronic's on rate of disabling stroke, but had more patients receiving a new pacemaker.
By Nick Paul Taylor • Sept. 26, 2019 -
Jacob Bell/MedTech Dive
FDA offers guidance on filing device applications electronically
The draft is the precursor to a series of documents that will detail the submission formats and implementation timelines for specific types of regulatory applications.
By Nick Paul Taylor • Sept. 26, 2019 -
EPA delays ethylene oxide sterilizer rule timeline amid industry pushback
Separately, it is unclear how long it will be until a second proposed rule that aims to address air pollution emissions from the ethylene production process is published.
By David Lim • Sept. 25, 2019 -
Medtronic plans to answer da Vinci with rival soft tissue robot
In a first look at the system Tuesday, CEO Omar Ishrak emphasized the company's effort is one of its most invested projects ever, calling it a "game changer." Medtronic anticipates FDA clearance in about two years.
By Susan Kelly • Sept. 25, 2019 -
To pitch Pre-Cert to Congress, FDA builds a case first
Enforcement mechanisms and the decision of how the experimental pathway will fit into the current 510(k), De Novo and PMA routes are among the details lawmakers will need to eventually address, an agency official said.
By Kim Dixon • Sept. 25, 2019 -
Device makers must adapt to rise of ASCs, analysts say
Bain & Company experts predict companies may consider new business models, such as taking equity stakes in ambulatory surgery centers to drive use of their latest devices.
By Nick Paul Taylor • Sept. 25, 2019 -
FDA grants breakthrough status to Aurora's concussion treatment
The non-invasive device uses near-infrared light to accelerate recovery from concussion.
By Nick Paul Taylor • Sept. 25, 2019
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