FDA tries to spur patient shaping of clinical trial design with draft guidance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

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

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Medical 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

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The agency issued draft guidance proposing a program to accredit testing labs that would perform premarket evaluations for device makers to determine if a product earns a declaration of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

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Draft guidance documents detail how four types of medical devices can come to market via the newly minted Safety and Performance Based Pathway rather than through the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