FDA: Page 81
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EU issues device, diagnostics database requirements
The documents detail what data manufacturers will need to include in the European Database on Medical Devices for devices and in vitro diagnostics under its new regulations.
By Susan Kelly • May 6, 2019 -
Boston Scientific wins FDA approval for Vici stent
The go-ahead creates competition for BD's Venovo stent, approved in March. Cook Medical and Medtronic are currently working to get their own versions to market.
By David Lim • May 6, 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 -
FDA seeks info on how patients view risks and benefits of devices
One health policy analyst was skeptical of the initiative, pointing to what she characterized as industry recruitment of desperate patients willing to use insufficiently tested products.
By Dana Elfin • May 3, 2019 -
FDA plan to limit old predicates not happening soon, 510(k) regulator says
A decision to cut off use of old predicates at a specific age would "be awful," Marjorie Shulman, the assistant director of 510(k)s at FDA, said.
By David Lim • May 3, 2019 -
FDA ends summary reporting, says it will not ban any breast implants
The agency laid out plans to improve the accessibility of safety information about breast implants and also announced it will make public all prior adverse event reports related to the devices within a matter of weeks.
By Maria Rachal • May 3, 2019 -
CMS to revamp coding for new medical technology
Medical device companies will now be able to apply for a new permanent Healthcare Common Procedure Coding System code twice a year instead of annually.
By David Lim • May 3, 2019 -
Medtronic gets FDA approval for wireless pacemaker programmer
The device is the follow-up to CareLink 2090, which has been dogged by cybersecurity weaknesses.
By Nick Paul Taylor • May 3, 2019 -
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 -
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 -
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
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