Medical Devices: Page 143
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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 -
Explore the Trendline➔
Sara Silbiger via Getty Images
TrendlineTop 5 stories from MedTech Dive
From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
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 -
TÜV 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The decision to revise the draft guidance comes after feedback on the 2017 version asked the agency to reconsider its approach, Bakul Patel, FDA's director for digital health, told MedTech Dive.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 -
Public health alert or legal advertising? It can be hard to tell.
AdvaMed applauded the FTC's move to send letters warning lawyers and lead generating firms over potentially unfair and deceptive ads seeking clients for personal injury suits.
By Dana Elfin • Updated Sept. 26, 2019 -
AdvaMed pegs medical device tax repeal hopes on year-end legislative package
A letter Tuesday from more than 600 other stakeholder organizations urges congressional leadership to permanently repeal the tax. But Stryker CEO Kevin Lobo said Monday a multi-year suspension is the most likely scenario.
By David Lim • Sept. 24, 2019 -
Can you pay for docs to work on cadavers in Las Vegas? Consult the updated ethics code.
"It's a demonstration of self-regulation and gives the industry that much more credibility as the government looks at these arrangements," Matt Wetzel, senior counsel with Akin Gump, said Monday at The MedTech Conference.
By Dana Elfin • Sept. 24, 2019 -
FDA tries to spur patient shaping of clinical trial design with draft guidance
"Patient experiences and insight can help us understand the benefits most important to patients and what risks patients may or may not be willing to tolerate," acting FDA Commissioner Ned Sharpless said in a statement.
By Nick Paul Taylor • Sept. 24, 2019 -
Medtronic updates Evolut TAVR system, gains FDA nod
The approval of the version designed for better delivery and sealing of the implant comes about a month after the agency authorized use of Medtronic's platform for patients considered at low mortality risk for open heart surgery.
By Susan Kelly • Sept. 23, 2019 -
EU changes for IVDs called a 'sea change,' revolutionary
The new in vitro diagnostic regulation, slated to come into effect May 2022, will for the first time subject as many as 90% of these diagnostics to review. Previously, most companies could self-certify.
By Dana Elfin • Sept. 23, 2019 -
Medtechs keep shareholders happy, potentially at pipeline's expense: EY
The industry recorded its highest revenues ever within the last year, an analysis by the consultancy shows. Even as R&D spending grew 11%, those investments fell short of the proportion of cash returned to investors.
By Maria Rachal • Sept. 23, 2019 -
FDA
FDA lays out vision for device conformity testing pilot
The agency issued draft guidance proposing a program to accredit testing labs that would perform premarket evaluations for device makers to determine if a product earns a declaration of conformity.
By Susan Kelly • Sept. 23, 2019 -
US exempts X-ray components, other devices from China tariffs
Varian said certain components sourced from China for linear accelerators made in the U.S. were exempted.
By David Lim • Updated Sept. 24, 2019
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