FDA: Page 12
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Retrieved from Wikimedia Commons on December 15, 2021
UK shares roadmap for creation of new medtech regulatory framework
The MHRA plans to have the “core elements” of the new framework for medical devices in place by the next year.
By Nick Paul Taylor • Jan. 12, 2024 -
Courtesy of Resmed
Resmed’s magnetized masks linked to 6 patient injuries, FDA says
The company contacted customers in November after determining magnets should be kept away from active implants and metallic medical devices.
By Nick Paul Taylor • Jan. 12, 2024 -
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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 -
Sara Silbiger via Getty Images
FDA adds vaporized hydrogen peroxide as sterilization alternative to EtO
The change supports the agency's efforts to reduce the use of ethylene oxide and strengthen the medical device supply chain.
By Elise Reuter • Updated Jan. 11, 2024 -
Sarah Silbiger via Getty Images
GE Healthcare notice about ventilator formaldehyde risk triggers FDA alert
The company warned customers about elevated levels of the toxic gas when its EVair or EVair 03 optional compressors are used in certain conditions.
By Nick Paul Taylor • Jan. 10, 2024 -
Sara Silbiger via Getty Images
J&J’s Megadyne restricts use of electrodes over burn risk, triggering Class I FDA notice
The J&J unit limited the use of the product in children after receiving reports of burn injuries that could be particularly harmful to them.
By Nick Paul Taylor • Jan. 9, 2024 -
Permission granted by Nanowear
Nanowear gets FDA clearance for undergarment that estimates blood pressure
The company’s continuous blood pressure monitor allows clinical investigators to remotely capture data on patients.
By Nick Paul Taylor • Jan. 5, 2024 -
magicmine via Getty Images
Renovos secures FDA breakthrough status for bone graft alternative
When injected, Renovite acts as a scaffold for cells and helps localize and retain molecules that stimulate healing.
By Nick Paul Taylor • Jan. 5, 2024 -
Sarah Silbiger via Getty Images
FDA warns providers not to buy or implant Synovo’s total hip system
Last year, the FDA sent a warning letter to Synovo after finding that its femoral resurfacing cup had been “significantly changed or modified.”
By Nick Paul Taylor • Jan. 4, 2024 -
Justin Sullivan via Getty Images
Apple Watch sales resume after latest twist in Masimo patent case
An appeals court has granted Apple’s emergency motion to pause the U.S. International Trade Commission’s ban on sales of its watches with a pulse oximetry feature.
By Susan Kelly • Jan. 3, 2024 -
Permission granted by Boston Scientific
Boston Scientific pulls forward expected approval for Farapulse PFA system
Analysts said a first quarter approval would increase their confidence in the company’s potential for sales growth of 10% or more.
By Nick Paul Taylor • Jan. 3, 2024 -
Patrik Stollarz / Staff via Getty Images
Philips recalls MRI machines due to risk of explosion
The Food and Drug Administration labeled the recall as a Class I event. There has been one report of a machine exploding in the 22 years the system has been in use.
By Nick Paul Taylor • Dec. 22, 2023 -
Resmed posts notice about risk of mask magnets interfering with medical implants
Like its rival Philips, Resmed has determined that patients should not wear magnetized masks near some implants.
By Nick Paul Taylor • Dec. 22, 2023 -
Courtesy of Grail
Roundup: Illumina’s long goodbye to cancer test maker Grail
From the start, the DNA sequencing leader faced pressure to unwind its $8 billion acquisition of the cancer screening developer. As 2023 drew to a close, it has finally agreed.
By Susan Kelly • Dec. 21, 2023 -
Permission granted by Grail
Grail CEO predicts ‘transformative’ 2024 amid Illumina split
The liquid biopsy maker, which Illumina plans to divest, said it has made progress on a PMA application with the FDA for its Galleri multi-cancer early detection test.
By Susan Kelly • Dec. 19, 2023 -
Sara Silbiger via Getty Images
FDA drafts guidance outlining real-world evidence for medical device submissions
By issuing the new guidance, the agency is meeting the requirements of a year-end spending bill.
By Elise Reuter • Dec. 19, 2023 -
Courtesy of Illumina
Illumina to part with Grail, ending battle with regulators
Activist investor Carl Icahn, who is suing the company over its acquisition of Grail, continued to push for the removal of several board members in a letter to fellow shareholders.
By Susan Kelly • Dec. 18, 2023 -
Permission granted by Glaukos Corporation
Glaukos wins FDA approval for drug-releasing eye implant to treat glaucoma
William Blair analysts said the product “should revolutionize how glaucoma is treated by addressing noncompliance with drops.”
By Nick Paul Taylor • Dec. 15, 2023 -
Alex Wong/Getty Images via Getty Images
In wake of Philips recall, senators urge review of FDA medical device oversight
Sens. Richard Durbin and Richard Blumenthal said the sleep apnea device maker “did nothing” while patients suffered.
By Susan Kelly • Dec. 14, 2023 -
HadelProductions via Getty Images
Zimvie’s collaboration with Brainlab delivers 510(k) win for spinal fixation system
Amid recent struggles in its spine unit, Zimvie has been expanding its Brainlab partnership.
By Nick Paul Taylor • Dec. 13, 2023 -
Courtesy of Illumina
Illumina prepares to divest Grail with Form 10 filing
The DNA sequencer is preparing to unwind its 2021 acquisition of the liquid biopsy test maker while still appealing orders to do so from regulators in the U.S. and Europe.
By Susan Kelly • Dec. 13, 2023 -
Courtesy of Becton Dickinson
BD receives 510(k) clearance for fingerstick blood test sample collection device
The clearance positions BD and partner Babson Diagnostics to support blood collection from community sites such as pharmacies.
By Nick Paul Taylor • Dec. 8, 2023 -
Courtesy of U.S. Food and Drug Administration
White House sets April target for finalization of FDA rule on lab developed tests
TD Cowen analysts said it is “unclear if and when FDA will finalize the rule as it has faced considerable opposition.”
By Nick Paul Taylor • Dec. 8, 2023 -
Karen Ducey via Getty Images
Laboratory trade group, providers oppose FDA’s lab developed test proposal
A CDRH spokesperson confirmed to MedTech Dive that a discrepancy in the submission system used for the proposed rule led to an initial overcount of public comments.
By Nick Paul Taylor • Updated Dec. 7, 2023 -
Tim Boyle via Getty Images
Baxter sends another safety notice about syringe infusion pump errors
The company shared “reinforced guidance” to mitigate the risk of underdosing and interruptions to treatment.
By Nick Paul Taylor • Updated Dec. 6, 2023 -
Permission granted by Becton Dickinson
BD tells customers not to use Cardinal’s Monoject syringes with Alaris pumps
The FDA labeled BD's safety notice as a Class I event. The warning comes amid several actions from the agency on the safety of syringes.
By Nick Paul Taylor • Dec. 4, 2023
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