FDA: Page 74
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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 -
Explore the Trendline➔
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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 -
Wikipedia user Coolcaesar / edited by Industry Dive
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 -
Jacob Bell / BioPharma Dive
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 -
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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 -
Jacob Bell
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 -
Jacob Bell / BioPharma Dive
FDA floats idea for assessing the risk-benefit profile of weight-loss devices
Concerned that some patients lack access to effective weight-loss devices, the agency is seeking feedback to inform guidance that it says will help device developers offer a wider variety of tools.
By Nick Paul Taylor • Sept. 6, 2019 -
More Blue Cross plans now covering Senseonics' implantable glucose monitor
The medtech recently snagged a new positive coverage decision from Health Care Services Corporation, the nation's fourth largest insurer, which operates Blue Cross Blue Shield plans covering 16 million members across five states.
By Nick Paul Taylor • Updated Oct. 15, 2019 -
Jacob Bell
Prescient gets FDA breakthrough status for colorectal cancer test
If eventually approved, the test's competition includes Exact Sciences' Cologuard and an older test for blood in fecal samples.
By Nick Paul Taylor • Sept. 5, 2019 -
FDA sets November ethylene oxide sterilization, duodenoscope safety advisory panel
The dual-topic expert panel will be tasked with developing recommendations for FDA on two of the largest challenges currently facing the Center for Devices and Radiological Health.
By David Lim • Sept. 3, 2019 -
Regulators put out call for experts to join device advisory committees
FDA is seeking people to sit on 18 panels that review medical device data and manufacturing regulations.
By Nick Paul Taylor • Sept. 2, 2019 -
FDA urges providers, manufacturers to transition to duodenoscopes with disposable parts
Boston Scientific told investors last year single-use duodenoscopes represent a market opportunity of more than $1 billion dollars.
By David Lim • Aug. 30, 2019 -
Jacob Bell / BioPharma Dive
Summer slowdown drags on for De Novos
The FDA has not announced a De Novo clearance in 12 weeks. Two-thirds of the way through 2019, pacing suggests the overall number of novel device approvals won't match 2018's high.
By Maria Rachal • Aug. 30, 2019 -
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McKesson, Philips devices flagged by DHS for cyber vulnerabilities
Certain cardiovascular IT systems and ultrasound devices could be exploited by hackers, the Department of Homeland Security wrote in separate notices.
By Nick Paul Taylor • Aug. 30, 2019 -
Jacob Bell
AdvaMed wins some, loses some in FDA guidance on managing uncertainty
While the agency tweaked parts of the document in line with feedback from AdvaMed and other groups, it maintained its plan to hold advisory committee meetings on certain postmarket data and kept other contested proposals.
By Nick Paul Taylor • Aug. 30, 2019
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