FDA: Page
-
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 -
Explore the Trendline➔
Sarah Silbiger via Getty Images
TrendlineTop 5 stories from MedTech Dive
From the effects of layoffs at the Food and Drug Administration and President Donald Trump’s tariff policies to the top medtech trends of 2026, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
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 -
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 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 -
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 -
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 -
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 -
Device tax repeal reintroduced in House, Senate (again)
AdvaMed Chairman and Stryker CEO Kevin Lobo said the repeal of the tax, set to go back into effect at the end of the year, is the top priority for the device lobby. But signs of movement may be months away.
By David Lim • April 11, 2019 -
Australia stops short of breast implant ban
Diverging from Canadian and French restrictions on certain breast implants, Allergan, Mentor and other manufacturers have 10 working days to provide information before regulators reconsider pulling products from the market.
By Maria Rachal • April 10, 2019 -
CMS floats broadening ambulatory blood pressure monitoring coverage
The proposed decision memo comes nearly a year after the American Heart Association and American Medical Association requested the agency consider expanding reimbursement.
By David Lim • April 9, 2019 -
Google, Fitbit, AdvaMed join to advance AI tools
The Consumer Health Technology-led initiative will provide standards and best practices for AI use in healthcare, including ethics and bias issues.
By Meg Bryant • April 8, 2019 -
LabCorp partners with Qiagen to speed launch of companion diagnostics
The collaboration leverages Qiagen's lab program for newly approved cancer drugs and targeted IVDs.
By Meg Bryant • April 5, 2019 -
FDA serves warning letter to Virginia lab over pharmacogenetic claims
The reprimand to Inova Genomics Laboratory comes as Congress considers granting the agency more authority to regulate laboratory developed tests.
By David Lim • April 5, 2019 -
Canada, France take hard action on textured breast implants
Australia's Therapeutic Goods Administration called a meeting of its BIA-ALCL expert working group to "inform decision making" in response to recent reviews of breast implants by FDA and other international regulators.
By Maria Rachal • Updated April 8, 2019 -
Australia strategizes to tighten medical device oversight
Regulators are considering mandating greater clinical evidence for certain high-risk devices, including spinal implants, diabetes management devices, medical devices used for IVF and companion diagnostics.
By David Lim • April 5, 2019
Previous
