FDA: Page 73
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FDA experts weigh evidence on patients' adverse reactions to common device metals
Suggestions from speakers at Wednesday's advisory panel included conducting comparative effectiveness studies, bolstering the informed consent process and requiring more stringent adverse event reporting.
By Maria Rachal • Nov. 13, 2019 -
Boston Scientific faces lower reimbursement despite White House lobbying bid
In an Office of Management and Budget meeting days before release of CMS' hospital outpatient payment final rule, execs argued the change would deter doctors from a procedure using a device that could reduce opioid dependence.
By David Lim • Nov. 13, 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 -
Paige gets CE mark for prostate cancer detection technology
The software is designed to make it easier for pathologists to analyze biopsies for signs of cancer.
By Nick Paul Taylor • Nov. 13, 2019 -
Eudamed 2-year delay doesn't mean free pass for manufacturers
"The Eudamed project is expensive both in time and resources. It is not just an IT project, this is a change project," said Eudamed.eu CEO Richard Houlihan.
By Dana Elfin • Nov. 12, 2019 -
FDA grants breakthrough status to AI-based gastric cancer diagnostic
The technology uses artificial intelligence to analyze endoscopy images for signs of gastric cancer.
By Nick Paul Taylor • Nov. 12, 2019 -
Duodenoscope reprocessors' poor work conditions exacerbate infection problem, FDA panel says
The advisory meeting followed FDA disclosing reports of three deaths, 45 patient infections and 159 cases of device contamination related to inadequate device reprocessing between October 2018 and March 2019.
By David Lim • Nov. 8, 2019 -
Medtronic reveals high-risk cyber vulnerability in electrosurgical generators
The Department of Homeland Security rated the vulnerability, which could be exploited remotely by a low-skilled hacker, a 9.8 on a 10-point risk scale.
By Nick Paul Taylor • Nov. 8, 2019 -
Deep Dive
Ethylene oxide plant closures put US on 'cusp of a major medical logistical failure'
FDA should consider asking HHS Secretary Alex Azar to declare a public health emergency and override state legislation to get sterilization plants back online, one advisory panel member said.
By David Lim • Nov. 8, 2019 -
Medicare overpays for certain orthotic devices, OIG finds
Medicare and beneficiaries reportedly paid $341.7 million more than other payers for certain orthotic devices, building on prior investigations' findings that CMS has overpaid for services like radiation and sleep studies.
By Nick Paul Taylor • Nov. 7, 2019 -
FDA pitched progressive device pathway to Warren and Murray, reversing Gottlieb
The former FDA chief told lawmakers last year that such a framework would not be suitable for human products, but now the agency says it could speed devices for children.
By David Lim • Nov. 6, 2019 -
7 questions about ethylene oxide as FDA panel convenes
Agency advisers are meeting again Thursday, having already encouraged FDA to incentivize lower industry reliance on EtO, while acknowledging state regulators' potential to strain sterilization capacity and create device shortages.
By David Lim • Updated Nov. 7, 2019 -
As Essure implant return deadline nears, FDA study enrollment inches up
The birth control device, which Bayer stopped selling in December 2018, has been linked to nearly 33,000 reports of adverse events, including 49 deaths.
By Susan Kelly • Nov. 5, 2019 -
Myriad shares plunge 40% after missing targets, slashing outlook
Investors punished the genetic test maker after it reported double-digit drops in sales of its key cancer and depression products.
By Nick Paul Taylor • Nov. 5, 2019 -
5 breakthrough devices qualify under finalized faster outpatient payment path
CMS said Medicare spending on the five approved devices, which do not need to meet substantial clinical improvement requirements to qualify for the pass-through payments, will be about $116 million in 2020.
By Susan Kelly • Nov. 4, 2019 -
Price transparency rule on ice in win for providers
The final outpatient payments rule from CMS did include plans to implement controversial site neutral provisions and cuts to 340B drug payments, both of which have been successfully challenged in court.
By Samantha Liss • Nov. 1, 2019 -
Trump picks MD Anderson's Stephen Hahn for FDA chief
Pending Senate confirmation, the Texas cancer center's chief medical executive and former American Society for Radiation Oncology board member will fill the agency's top seat.
By Maria Rachal • Updated Nov. 1, 2019 -
New tech add-on payment for innovative dialysis products final in ESRD, DME rule
Following criticism from industry, CMS did not go through with a plan to use technology assessments to determine comparableness to older items to help establish fee schedule amounts for durable medical equipment.
By David Lim • Nov. 1, 2019 -
Medtronic thoracic stent graft system approved in Japan
The device addresses common attributes and conditions in the Japanese patient population such as greater aortic fragility, smaller anatomy and aortic wall stress, the director of the Japanese Society for Vascular Surgery said.
By Nick Paul Taylor • Nov. 1, 2019 -
Warren, Murray, Smith redouble scrutiny of FDA over Pre-Cert safety, authority
FDA maintains it has the statutory authority to conduct the software Pre-Cert pilot, but acknowledged it will need help from Congress to update what it calls a 40-year-old regulatory paradigm for 21st century technologies.
By David Lim • Oct. 31, 2019 -
FDA puts J&J's Ethicon surgical stapler recall in top risk category
Ethicon had learned of seven serious injuries and one death related to the recalled products by the time it began pulling the devices from the market.
By Nick Paul Taylor • Oct. 31, 2019 -
It's official: EC confirms 2-year Eudamed delay
The database will now go live in May 2022, giving the industry a reprieve and more time to complete projects.
By Dana Elfin • Oct. 30, 2019 -
CMS proposes lifting restrictions on NGS cancer testing
The agency revised its proposed national coverage determination after receiving more than 80 comments, with potential plans to extend coverage of next generation sequencing tests to earlier-stage and hereditary cancers.
By Nick Paul Taylor • Oct. 30, 2019 -
Jacob Bell/MedTech Dive
Surmodics gets breakthrough tag for critical limb ischemia device
The Minnesota medtech, which is also in the midst of testing a drug-coated balloon licensed by Abbott, now has a boost from FDA in bringing to market a sirolimus-delivering device designed to prevent amputation and death.
By Nick Paul Taylor • Oct. 30, 2019 -
Eudamed reportedly delayed 2 years, IVDR gets 2nd notified body
BSI joins Dekra Germany as designated under the In Vitro Diagnostic Regulation ahead of its 2022 implementation date.
By Dana Elfin • Oct. 28, 2019 -
UK regulator mulls blocking Illumina's $1.2B PacBio takeover
The watchdog said the union "would result in a significant reduction of competition," leading some analysts to predict the deal won't go through.
By Nick Paul Taylor • Oct. 25, 2019
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