FDA: Page 21
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Permission granted by Erik Vollebregt
Q&AFriday Q&A: A regulatory attorney breaks down the EU MDR transition
Amsterdam-based regulatory expert Erik Vollebregt explains the agreement this week to extend the deadlines to comply with the EU’s Medical Device Regulation, and the issues that still need to be addressed.
By Susan Kelly • March 10, 2023 -
Courtesy of QuidelOrtho
QuidelOrtho COVID test is first to win FDA nod via premarket review
Special controls instituted by the FDA as part of the De Novo assessment pave the way for other tests to come to market without pandemic-era Emergency Use Authorization.
By Nick Paul Taylor • March 9, 2023 -
Explore the Trendline➔
Sitthiphong via Getty Images
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 -
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More woes for breast implants, as FDA links procedure to squamous cell carcinoma
Three deaths were related to the cancer cases, the agency said.
By Elise Reuter • March 8, 2023 -
Courtesy of Sooma
Sooma’s neuromodulation therapy for depression granted FDA breakthrough status
The patient-administered device, which uses a mild electrical current to improve depressive symptoms, showed promising results in a clinical trial.
By Nick Paul Taylor • March 8, 2023 -
AdvaMed calls Europe’s MDR extension a ‘strong step forward,’ but warns challenges remain
The extra time to certify medical devices in Europe is intended to prevent shortages, but the regulatory overhaul still poses problems for medtech firms, the U.S. lobbying group says.
By Susan Kelly • March 7, 2023 -
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Medtechs plan to centralize regulatory information management in modernization push: survey
The survey suggests that more than two-thirds of medtech firms need to update and automate their regulatory record-keeping and submission practices.
By Nick Paul Taylor • March 7, 2023 -
titoOnz via Getty Images
Medtech industry relieved as Europe’s MDR extension nears final approval
While the extra time to comply is aimed at preventing medical device shortages, the rules have still left some device makers and certifying bodies unclear about how to proceed, says one attorney.
By Susan Kelly • March 6, 2023 -
Win McNamee / staff via Getty Images
Elon Musk’s bid to study brain implant in humans rejected by FDA on safety grounds: report
The FDA reportedly raised concerns about the device’s lithium battery, the potential for its wires to migrate across the brain, and how it would be removed.
By Nick Paul Taylor • March 3, 2023 -
Sarah Silbiger via Getty Images
FDA Class I recalls hit 15-year high in 2022
The jump in activity happened in a year in which the number of all recalls rose by around 10%, including actions by Baxter, Medtronic and Philips.
By Nick Paul Taylor • March 3, 2023 -
Courtesy of Dexcom
Medicare to expand CGM coverage to more Type 2 diabetes patients
The updated policy could double the market for continuous glucose monitors, and will take effect in April.
By Elise Reuter • Updated March 2, 2023 -
Sarah Silbiger/Getty Images via Getty Images
FDA moving ahead with rulemaking on lab developed tests without waiting for Congress: BioWorld
A senior FDA official said the agency cannot “just stand by” given the failure of Congress to pass legislation addressing regulation of the increasingly complex tests.
By Nick Paul Taylor • March 2, 2023 -
Giuseppe Lombardo via Getty Images
Remote patient monitoring increasingly popular, even as pandemic eases, analysis of insurance claims shows
Cardiologists are the main users of RPM devices, with blood pressure diagnoses accounting for more than half of all claims made in 2021. Diabetes, which accounts for 16% of claims, is the next most active area.
By Nick Paul Taylor • March 2, 2023 -
Megan Quinn/MedTech Dive
AdvaMed unveils policy priorities with focus on breakthrough device coverage, global market access
Congress should also prioritize protecting the medtech manufacturing supply chain and enact diagnostic testing reform, the lobbying group said in releasing a set of nine policy goals.
By Susan Kelly • March 1, 2023 -
Courtesy of U.S. Food and Drug Administration
FDA authorizes first at-home flu-COVID-19 combination test days after its developer files for bankruptcy
Lucira filed for bankruptcy protection last week, saying the “protracted” authorization process caused it to miss out on test sales in the 2022 to 2023 flu season.
By Nick Paul Taylor • Feb. 27, 2023 -
Courtesy of Getinge
Getinge has CE marks suspended on life support sets over sterile packaging issues
Getinge said it is “aware of the severe situation this suspension puts on healthcare and critically ill patients” and is “working urgently to minimize the impact.”
By Nick Paul Taylor • Feb. 24, 2023 -
Courtesy of AliveCor
Biden upholds finding that Apple Watch violated AliveCor’s patents
A ban on the infringing Apple Watches could be enacted under a ruling by the International Trade Commission, but a separate patent case must be resolved first.
By Elise Reuter • Feb. 21, 2023 -
artJazz via Getty Images
Device makers gain more time to adapt to Europe’s MDR after EU vote
The European Parliament’s approval means that medtech manufacturers have until 2027 or 2028 to comply with the new rules, depending on device class.
By Susan Kelly • Feb. 17, 2023 -
Courtesy of GE HealthCare
GE’s nuclear imaging device can crush patients, FDA says, as Class I recall issued
GE HealthCare has told customers to stop using the machines until company technicians can inspect them and replace dangerous parts.
By Nick Paul Taylor • Feb. 17, 2023 -
bymuratdeniz via Getty Images
AI devices need dedicated FDA regulatory pathway to reduce bias risk, say researchers
Scientists argue for a new regulatory process to prevent AI software from reinforcing existing health disparities.
By Nick Paul Taylor • Feb. 16, 2023 -
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Boston Scientific, MDMA call for more transparency and oversight of Medicare Advantage plans
Privately offered Medicare Advantage plans “do not often provide a clear reason for the denial of coverage, and rarely offer any visibility into the evidence and methodology,” trade group MDMA and Boston Scientific said.
By Nick Paul Taylor • Feb. 15, 2023 -
Alex Wong via Getty Images
OpinionPatent trolls’ destructive lawsuits are curbing US medtech innovation
The Patent and Trademark Office must help stop frivolous litigation that is harming the industry, argues former HHS secretary Tom Price.
By Tom Price • Feb. 10, 2023 -
Courtesy of Philips
82 more deaths linked to Philips’ recalled devices reported to FDA, bringing total to 346
The rate of death reports per month has risen consistently since Philips began the recall in the summer of 2021.
By Nick Paul Taylor • Feb. 10, 2023 -
pcess609 via Getty Images
Abbott balloon device partner Surmodics cuts jobs after FDA approval delay
The workforce reduction, one of a growing number in the medtech sector, comes after the agency requested more data in a premarket review of the company’s device to treat narrowed leg arteries.
By Susan Kelly • Feb. 9, 2023 -
Chip Somodevilla via Getty Images
Biden zeroes in on drug costs during State of the Union address
The president called for extending Medicare's $35 insulin price cap to all Americans and blasted “big pharma” for record profits while at the same time “unfairly charging people hundreds of dollars.”
By Shannon Muchmore • Feb. 8, 2023 -
Pijitra Phomkham via Getty Images
Trade group pushes back on FDA’s clinical decision support guidance
The Clinical Decision Support Coalition is asking the agency to rescind its guidance and propose new rules that change how software tools are regulated as medical devices.
By Elise Reuter • Feb. 8, 2023
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