FDA: Page 82
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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 -
Explore the Trendlineâž”
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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 -
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 -
FDA seeks to step up mammography oversight, info sharing
A new rule would standardize how facilities are required to inform patients of their breast tissue density, which can impact imaging efficacy and overall breast cancer risk.
By Maria Rachal • March 28, 2019 -
PwC predicts device makers, pharma to benefit from FDA digital health regulations
The consultants think pharma is well placed to benefit from FDA's changes, but acknowledge medtech has an early advantage.
By Nick Paul Taylor • March 28, 2019 -
Neuronetics gets Japanese coverage for antidepressant device
The coverage decision for the transcranial magnetic stimulation device was supported by an observational study of 307 patients with major depressive disorder.
By Nick Paul Taylor • March 28, 2019 -
Grassley slams Verma over lab overpayment answers
CMS Administrator Seema Verma acknowledged the agency relied on maximum payment rates as a baseline for the clinical laboratory fee schedule rather than average rates.
By David Lim • March 27, 2019
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