FDA: Page 87
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Abbott gets WHO prequalification for point-of-care HIV test
The diagnostic can expand access to viral load testing in resource-limited settings and improve management of HIV, Abbott said.
By Nick Paul Taylor • May 3, 2019 -
FDA launches 'super office' to link pre and postmarket review
Agency leaders said the pilot tested over the past year has yielded "significant improvements" in identifying safety issues, and industry should see benefits as well.
By David Lim • May 2, 2019 -
Explore the Trendline➔
Permission granted by Boston Scientific
TrendlineNew medical devices are reshaping the medtech industry
From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.
By MedTech Dive staff -
Tunbridge named interim MHRA medical device chief as Wilkinson retires
Graeme Tunbridge has been with the agency since 2011 and has spent the bulk of his time working on measures to strengthen medical device regulation.
By Nick Paul Taylor • Updated Oct. 21, 2019 -
Japanese ortho device market grows, despite steep barriers to entry
The second largest market for U.S.-made medical devices comes with unique regulatory and reimbursement hurdles.
By Meg Bryant • May 1, 2019 -
FDA publishes guidance on device performance bench tests
The document outlines what manufacturers ought to include in test report summaries, test protocols and complete test reports.
By Susan Kelly • April 26, 2019 -
FDA cautions against off-label use of Stryker's Wingspan stent system
The agency flagged increased risk of stroke and death from non-indicated uses of the intracranial stenosis device, citing postmarket data from a study mandated by regulators in 2012.
By Maria Rachal • Updated April 29, 2019 -
Jacob Bell/MedTech Dive
Manufacturers get finalized guidance from FDA on orthopaedic device material
The text is intended to help companies understand what data to submit when seeking clearance for devices made with a biomaterial commonly found in spinal implants and knee and hip replacements.
By Nick Paul Taylor • April 26, 2019 -
FDA hits Abaxis with warning letter over changes to assay
The warning letter comes nine months after Zoetis paid $2 billion to acquire Abaxis and its portfolio of veterinary point-of-care diagnostics.
By Nick Paul Taylor • April 25, 2019 -
FDA pitches stronger controls, new labeling for surgical staplers
The proposed order follows an agency review that found the widely used tools were linked to numerous problems and serious complications, including 366 deaths, over a seven-year period.
By Susan Kelly • April 24, 2019 -
CMS floats new add-on payment route for breakthrough devices
The agency's proposed rule for 2020 outpatient payments pitches a similar alternative pathway aimed at speeding coverage for select medical technologies.
By David Lim • Updated July 31, 2019 -
Playing catch up, Boston Scientific gets FDA approval for Lotus TAVR device
The U.S. OK comes 30 months after an issue with the delivery system locking mechanism led Boston Scientific to stop installations of the product in Europe.
By Nick Paul Taylor • April 24, 2019 -
FDA advisory panels set for surgical staplers, paclitaxel devices
Regulators are seeking expert advice regarding paclitaxel-coated devices in peripheral artery disease patients, and on surgical staplers, which FDA suggests should be reclassified after a spike in adverse event reports.
By Maria Rachal • April 23, 2019 -
Sponsored by ZS
What it takes for multinational medtech companies to succeed in China
With a population of 1.4 billion, China is a market that most medtech companies can’t afford to ignore. However, there are a lot of obstacles that make navigating the Chinese market a challenge.
April 23, 2019 -
Trade groups seek to guide suppliers past pitfalls of new CMS bidding process
The new lead item bidding model could lead to significant reductions in Medicare rates for medical equipment.
By Nick Paul Taylor • April 23, 2019 -
USMCA would boost medtech industry, ITC report finds
AdvaMed urged Congress to ratify the agreement "as expeditiously as possible," arguing the International Trade Commission report demonstrates it would be an improvement over the North American Free Trade Agreement.
By David Lim • April 22, 2019 -
FDA wants details on nitinol in premarket device applications
The agency aims to gather more thorough information from manufacturers in its effort to gauge the widely used metal's potential to corrode or cause allergic reactions.
By Susan Kelly • April 22, 2019 -
CDC rule removes barrier to sale of escape respirators
The deregulatory action was inspired by concern that underground coal miners could face a dangerous shortage of the breathing devices, relied on as a means of survival in emergencies.
By Susan Kelly • April 22, 2019 -
FDA grants breakthrough status to preeclampsia device
Advanced Prenatal Therapeutics designed the device to remove pathogenic factors from a mother's blood, seeking to prevent a pregnancy condition that can be fatal.
By Nick Paul Taylor • April 18, 2019 -
WHO weighs in on digital health tools in new report
The World Health Organization reviewed 10 digital health interventions, backing use of mobile devices for functions like clinical decision support and telemedicine. Still, a top official said the strategies are "not a silver bullet."
By Nick Paul Taylor • April 18, 2019 -
FDA orders Boston Scientific, Coloplast to pull transvaginal mesh from market
The medtechs have 10 days to submit a withdrawal plan, two months after an agency advisory panel noted a worrisome lack of long-term safety and effectiveness data for the much-litigated pelvic organ prolapse repair devices.
By Maria Rachal • April 17, 2019 -
FDA progressive device approval proposal raises eyebrows
Former FDA Commissioner Scott Gottlieb told MedTech Dive during his last week in office he believes stepwise approval should only be used for animal drugs, not human medical products.
By David Lim • April 16, 2019 -
EU device group clarifies incoming database requirements
The publication of the guidelines comes as Europe races to be ready for the implementation of new medical device regulations.
By Nick Paul Taylor • April 16, 2019 -
Deep Dive
CDRH Director Shuren: Safety and innovation are 'two sides of same coin'
The device chief said in a wide-ranging interview with MedTech Dive a major challenge for the agency is fighting the perception that speeding new devices to market comes at the cost of patient safety, or vice versa.
By David Lim • April 15, 2019 -
FDA flags breathing tube shortage tied to sterilization plant closing
The temporary scarcity of Smiths Medical tracheostomy tubes, especially for pediatric use, is FDA's first confirmation of a specific device shortage tied to the shutdown of Illinois contract sterilization company Sterigenics.
By Susan Kelly • April 15, 2019 -
Contaminated duodenoscopes linked to 3 new deaths, 45 more infections, FDA says
The agency signaled impatience with manufacturers Olympus, Fujifilm and Pentax for failing to comply with timelines for completing post-market studies.
By Susan Kelly • April 15, 2019
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