FDA: Page 25
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Fraud risk increased among Medicare DME suppliers who enrolled under pandemic waivers: GAO
Of 208 providers that had their Medicare enrollment revoked between 2020 and 2022, 83% were durable medical equipment suppliers, according to a report from the Government Accountability Office.
By Elise Reuter • Dec. 19, 2022 -
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Click wins FDA breakthrough designation for prescription digital migraine therapy
The designation would give Click Therapeutics expedited review of its preventive treatment for episodic migraine in adults.
By Nick Paul Taylor • Dec. 19, 2022 -
Explore the Trendline➔
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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 -
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Healthcare groups urge Congress to pass diagnostic testing reform before year’s end
After the VALID Act was dropped from an FDA funding package, healthcare groups are asking legislators to add it to a year-end funding bill.
By Elise Reuter • Dec. 13, 2022 -
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EU Health Commissioner proposes MDR delay to prevent medical device shortages
Plans to delay MDR certification to 2027 for high-risk devices and 2028 for others may still not be enough to stave off shortages.
By Nick Paul Taylor • Updated Dec. 23, 2022 -
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Cochlear’s $120M purchase of hearing-implant maker stirs European scrutiny
The European Commission said the merger “threatens to significantly affect competition in the market for cochlear implants and bone conduction solutions.”
By Nick Paul Taylor • Dec. 9, 2022 -
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AdvaMed asks FDA to withdraw divisive draft guidance on LASIK surgery
Some comments were more supportive, with the American Optometric Association calling the agency’s proposal “timely and beneficial.”
By Nick Paul Taylor • Dec. 8, 2022 -
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FDA outlines benefits and risks of emerging augmented and virtual reality medical devices
AR/VR may increase access to healthcare and make procedures less invasive, but could potentially cause cybersickness and head and neck strain.
By Nick Paul Taylor • Dec. 8, 2022 -
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18M projected to lose Medicaid coverage at end of COVID-19 emergency
Many people who are currently enrolled in Medicaid will transition to other coverage, but 3.8 million people will completely lose insurance, according to the Robert Wood Johnson Foundation.
By Susan Kelly • Dec. 6, 2022 -
Courtesy of Getinge
Getinge heart support devices join FDA shortage list as raw-materials supply slows production
Maintenance cycles for pumps and batteries have been extended and Getinge asked hospitals to share underutilized devices.
By Nick Paul Taylor • Dec. 5, 2022 -
Permission granted by Becton Dickinson
Vulnerability in BD’s infusion pump flagged to US cybersecurity agency
An attacker with physical access to the device could exploit the vulnerability to change the configuration settings or disable the pump.
By Nick Paul Taylor • Updated Dec. 6, 2022 -
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The 10 biggest medtech stories of 2022
MedTech Dive reporting this year has explored how companies maintained momentum even amid supply shortages and rising inflation rates.
By MedTech Dive staff • Dec. 3, 2022 -
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European biomedical group backs delaying MDR certification deadline amid ‘looming crisis’
Pushing back the recertification deadline may buy time to address problems such as the shortage of capacity at certifying organizations.
By Nick Paul Taylor • Dec. 1, 2022 -
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Monkeypox to be renamed by WHO; ‘mpox’ will phase in over next year
The name change comes amid an outpouring of “racist and stigmatizing” language, the organization said.
By Peter Green • Nov. 28, 2022 -
Courtesy of Hillrom/Baxter
Baxter recall of connected incontinence pads ranked by FDA as Class I event
The recall was assigned to the highest risk category as it could affect medically necessary devices, including insulin pumps and fetal monitors.
By Nick Paul Taylor • Nov. 28, 2022 -
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Europe faces 2024 bottleneck in device reapprovals as submissions slow
While approval certificates for three-fourths of Europe’s medical devices will expire in 2024, a survey found no increase in the pace of submissions.
By Nick Paul Taylor • Nov. 28, 2022 -
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‘Tripledemic’ concerns spur FDA to issue emergency authorization for flu-COVID-19 combination test
Experts have warned “a viral hurricane is making landfall” as cases of RSV, influenza and COVID-19 rise simultaneously.
By Nick Paul Taylor • Nov. 23, 2022 -
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State AGs urge Apple to protect consumers’ reproductive health data
Apps holding sensitive health data should be required to delete nonessential information and clearly inform consumers what information they share with parties such as law enforcement, the 10 state attorneys general said.
By Rebecca Pifer • Nov. 22, 2022 -
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Zimmer lands 510(k) clearance for 3D-printed cementless knee replacement
The new joint uses anatomical data in combination with 3D printing to try to directly mimic the architecture of human spongy bone.
By Nick Paul Taylor • Nov. 22, 2022 -
Apple Watch app for monitoring Parkinson’s symptoms earns FDA clearance
The technology has been validated in a clinical trial, positioning h2o to create an app that enables real-time sharing of Parkinson’s symptom data.
By Nick Paul Taylor • Nov. 21, 2022 -
Michelle Rock/MedTech Dive, data from Getty Images
AdvaMed pushes Biden to use $52B chip program to support medtech supply chains
The group wants agencies to coordinate with the medtech industry to ensure investments are directed toward “technologies that power medical devices.”
By Nick Paul Taylor • Nov. 18, 2022 -
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Philips’ ventilator woes grow as FDA issues alert over replacement foam
Replacement noise reduction material in Trilogy ventilators can block the air inlet and let trace amounts of particulate matter into the air pathway.
By Nick Paul Taylor • Nov. 18, 2022 -
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Roche gets EUA for high-throughput monkeypox test
The test targets two regions of the monkeypox genome, which were picked as they are less prone to mutations than other parts of the virus.
By Nick Paul Taylor • Nov. 17, 2022 -
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5 takeaways from the FDA’s list of AI-enabled medical devices
As the number of devices increases, the agency is looking to adapt its regulatory framework to the new technology, including faster approval of algorithm updates.
By Elise Reuter • Nov. 7, 2022 -
Courtesy of Nuheara
Q&AQ&A: Nuheara CEO talks about market potential for OTC hearing aids
John Luna discusses how the FDA’s new category of medical-quality, non-prescription hearing aids is poised to change the market.
By Peter Green • Nov. 3, 2022 -
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BioIntelliSense adds skin-color sensitivity to pulse oximeter chips amid FDA concerns over fingertip devices
An IT-driven blood-oxygen meter may help reduce a racial disparity in care caused by erroneous readings.
By Peter Green • Updated Nov. 2, 2022
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