FDA: Page 75
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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The agency issued draft guidance proposing a program to accredit testing labs that would perform premarket evaluations for device makers to determine if a product earns a declaration of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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TrendlineMedical device safety in spotlight after high profile recalls
From Philips’ massive recall of respiratory devices to ongoing health risks with breast implants, medical devices tied to patient harm have put a focus on product safety.
By MedTech Dive staff -
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 -
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Draft guidance documents detail how four types of medical devices can come to market via the newly minted Safety and Performance Based Pathway rather than through the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 -
FDA creates agencywide tech modernization roadmap
The agency plans to spend the next one to two years upgrading its infrastructure to meet emerging data handling needs.
By Nick Paul Taylor • Sept. 19, 2019 -
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 -
TAVR surgical bailout rate fuels talk of relaxing requirements
Some cardiologists argued the results suggest transcatheter aortic valve replacements can be performed by facilities that lack on-site surgical standby.
By Nick Paul Taylor • Sept. 18, 2019 -
CMS mandatory radiation oncology model should be scaled back, industry argues
The model would examine effectiveness of site-neutral episode-based payments for treatment of 17 cancer types to radiotherapy providers and suppliers in randomly selected geographic areas.
By David Lim • Sept. 17, 2019 -
Establishment Labs gets IP boost ahead of pitch for breast implant market
The patent news is a positive for efforts to claim a slice of the volatile breast implant market, analysts at Cowen said.
By Nick Paul Taylor • Sept. 17, 2019 -
FDA warns closure of Atlanta Sterigenics facility could impact medical device supply
Sterigenics said it aims to complete construction of technology upgrades at the plant, designed to reduce ethylene oxide emissions, by early October.
By David Lim • Sept. 16, 2019 -
FDA finalizes 4 guidances to clarify 510(k) pathways
The documents spell out the agency's initiatives for improving the 510(k) premarket review pathway to promote faster access to new medical technologies.
By Susan Kelly • Sept. 13, 2019 -
American Kidney Fund lobbies White House on charitable premium assistance
Insurers are pushing for a reexamination of policies they argue allow financially interested third parties to steer end-stage renal disease patients eligible for Medicare or Medicaid to private plans.
By David Lim • Sept. 13, 2019 -
FDA clears GE's AI-powered x-ray algorithms for triaging collapsed lungs
GE Healthcare said the technology will help hospitals identify high-priority cases and fast track treatment.
By Nick Paul Taylor • Sept. 13, 2019 -
EU sets out requirements for MDR expert panel members
Notified bodies must consult with the panels before clearing certain high-risk devices for marketing.
By Nick Paul Taylor • Sept. 12, 2019 -
US needs cyber-savvy doctors as connected device use rises, FDA panel says
Patients deserve cybersecurity training as part of the informed consent process, but healthcare providers aren't well-equipped to offer it, an FDA advisory committee said Tuesday.
By Maria Rachal • Sept. 11, 2019 -
Notified body BSI certifies 1st device under EU MDR
The new law will require a plethora of products that formerly didn't need certification by a notified body to undergo review.
By Dana Elfin • Sept. 11, 2019 -
Physicians push FDA to shed light on device comparators
In a paper published in JAMA Network Open on Wednesday, physicians analyzed evidence used in the authorizations of products under the Humanitarian Device Exemption pathway.
By Nick Paul Taylor • Sept. 11, 2019 -
EBR gets FDA breakthrough tag for wireless cardiac pacing system
The device is designed to synchronize the left and right ventricles without subjecting patients to lead implantation.
By Nick Paul Taylor • Sept. 11, 2019 -
FDA looks to define 'triggers' for medical device cybersecurity warnings
When do the benefits of notifying patients of potential risks outweigh possible harms? The agency's Patient Engagement Advisory Committee is weighing in Tuesday.
By Maria Rachal • Sept. 10, 2019 -
Doubt cast on value of Exact Sciences' Cologuard
Research commissioned by CMS found the test is "less effective and considerably more costly" than other colorectal cancer screening methods.
By Nick Paul Taylor • Sept. 10, 2019 -
FDA finalizes guidance for accepting De Novo requests
In the guidance, the agency explains procedures and criteria for assessing whether a device manufacturer's De Novo classification request should be accepted for a substantive review.
By Susan Kelly • Sept. 9, 2019 -
FDA finalizes guidance on HDEs after AdvaMed scrutiny
Industry advocates had criticized FDA's tight parameters on which humanitarian use devices are eligible to turn a profit, but the final guidance largely mirrors the draft.
By Susan Kelly • Sept. 6, 2019
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