FDA: Page 16
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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 -
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Sarah Silbiger via Getty Images
TrendlineMedical device safety in spotlight after high profile recalls
From Philips’ massive recall of respiratory devices to ongoing health risks with breast implants, medical devices tied to patient harm have put a focus on product safety.
By MedTech Dive staff -
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 -
Courtesy of Vivos Therapeutics
Vivos receives FDA 510(k) clearance for oral devices to treat severe sleep apnea
The clearance positions the company to offer an alternative to continuous positive airway pressure devices and neurostimulation implants.
By Nick Paul Taylor • Nov. 30, 2023 -
Anna Shvets via Pexels
GE HealthCare gets 510(k) clearance for algorithm to detect collapsed lungs
The system provides immediate notifications to support the triaging of emergency room patients.
By Nick Paul Taylor • Nov. 29, 2023 -
Sara Silbiger via Getty Images
Unomedical recall of infusion sets tagged as Class I by FDA
The company notified Tandem Diabetes Care, its sole consignee, in October of the risk for infusion sets to detach from insulin pumps, disrupting insulin delivery.
By Nick Paul Taylor • Nov. 28, 2023 -
Matt Rourke/AP
Deep DiveWhy medical device companies are worried about the EPA’s planned sterilization regs
The EPA is expected to finalize new regulations in March that would limit ethylene oxide emissions from companies that sterilize medical devices.
By Elise Reuter , Shaun Lucas • Nov. 27, 2023 -
Sarah Silbiger via Getty Images
FDA withdraws from Global Harmonization Working Party
The agency has become “concerned with the divergent harmonization efforts for medical devices” and will focus on working with the International Medical Device Regulators Forum going forward.
By Elise Reuter • Nov. 27, 2023 -
Андрей Клеменков via Getty Images
FDA weighs in on SoClean’s field correction for CPAP cleaning machines
SoClean announced a voluntary field action last week to address user complaints related to improper set-up and unauthorized modifications.
By Nick Paul Taylor • Nov. 22, 2023 -
Courtesy of Medtronic
Medtronic wins pulsed field ablation CE mark, teeing up 2-front challenge to Boston Scientific
Medtronic received the mark for its single-shot PFA device, clearing the company to expand its portfolio of European atrial fibrillation devices.
By Nick Paul Taylor • Nov. 22, 2023 -
FDA concerned Cardinal Health failed to mitigate risk of incompatible syringes
Days after posting the Class 1 recall notice, the FDA said changes made to certain syringes could lead to overdose, underdose, or delays in therapy or alarms.
By Nick Paul Taylor • Nov. 21, 2023
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