Medical Devices: Page 136
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Brian Tucker
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 -
Getty Images
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 -
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 -
Jacob Bell / BioPharma 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 -
National Institute on Drug Abuse, National Institutes of Health
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 -
AdvaMed
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 -
AdvaMed
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 -
Adobe Stock
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 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 -
Getty Images
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 -
Jacob Bell
NESTcc, ophthalmic imaging first up in FDA medical device 'collaborative communities'
Creation of these groups of manufacturers, payers, regulators, patients and health professionals is one of the device center's 2018-2020 strategic priorities.
By David Lim • Sept. 20, 2019 -
Active Implants gets FDA breakthrough status for knee implant
NUsurface is designed for patients who still suffer pain after undergoing a meniscectomy, one of the most widely performed surgical procedures.
By Nick Paul Taylor • Sept. 20, 2019 -
Jacob Bell / BioPharma Dive
FDA moves to end need for predicate comparisons in some 510(k)s
Draft guidance documents detail how four types of medical devices can come to market via the newly minted Safety and Performance Based Pathway rather than through the conventional approach.
By Nick Paul Taylor • Sept. 20, 2019 -
Senate lawmakers direct CMS to boost non-opioid device reimbursement
The medical device industry is seeking congressional support to force Medicare to increase payment after CMS rejected the idea in a hospital outpatient rule proposed in August.
By David Lim • Sept. 19, 2019 -
J&J settles with West Virginia over allegations on mesh, hips
The $3.9 million settlement resolves the state attorney general's claims that Ethicon and DePuy unlawfully marketed the much-litigated surgical mesh and hip replacement devices.
By Maria Rachal • Updated May 5, 2020 -
UK shares 'responsible person' advice as no-deal Brexit looms
The update comes against a backdrop of rising concerns that Britain will leave the European Union without a deal.
By Nick Paul Taylor • Sept. 19, 2019 -
FDA outlines new path to market, mirroring breakthrough designation
The agency Wednesday morning issued draft guidance for medical devices or device-led combination products expected to "significantly improve" safety compared to existing treatments for non-life-threatening diseases.
By David Lim • Sept. 18, 2019 -
Mesh as good as hysterectomy for prolapse, 3-year NIH data suggests
The latest clinical trial outcomes appear in JAMA five months after FDA said mesh manufacturers had failed to prove adequate safety and effectiveness of the devices in patients with pelvic organ prolapse.
By Maria Rachal • Sept. 18, 2019
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