FDA: Page 83
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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 -
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 -
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 -
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 -
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 -
FDA unveils framework for AI-based medical devices
The agency argued a total product lifecycle approach, including performance monitoring, is needed to regulate artificial intelligence and machine learning software as a medical device.
By David Lim • April 3, 2019 -
Industry groups seek safe harbor in comments to senator's cybersecurity query
A think tank's analysis of several organizations' recommendations highlights the need for a national strategy and greater collaboration among various stakeholders.
By Meg Bryant • April 3, 2019 -
FDA repeals some regs on radiation-emitting devices
The agency said it believes its revised rules will continue to protect patients and health professionals against harmful radiation exposure from electronic products and medical devices.
By Susan Kelly • April 1, 2019 -
CMS to tackle lab payments codes in pair of public meetings
The agency will meet on June 24 to hear comments on setting payment amounts for codes being considered under the Clinical Laboratory Fee Schedule for 2020.
By Susan Kelly • April 1, 2019 -
FDA finalizes rules for anthrax bacteria tests, spine devices
Both devices have been classified as Class II, with special controls, and will continue to require a 510(k) premarket notification.
By Susan Kelly • April 1, 2019 -
FDA floats 5-day notice for device inspections in draft guide
The agency is filling an obligation under the FDA Reauthorization Act of 2017 to adopt uniform standards around not-for-cause inspections.
By David Lim • March 29, 2019 -
Cardiologists push digital health tools as answer to healthcare funding pressures
A European Society of Cardiology working group wants health systems to reimburse digital health tools for more efficient chronic disease care.
By Nick Paul Taylor • March 29, 2019 -
UK provides more no-deal Brexit advice as logjam drags on
The latest guidance, covering certain types of marketing authorizations and the provision of scientific advice, comes the same week Britain had planned to leave the EU.
By Nick Paul Taylor • March 29, 2019
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