Policy & Regulation: Page 2
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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 -
Johnny Greig via Getty Images
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 -
Explore the Trendline➔
Sitthiphong via Getty Images
TrendlineMedical device industry continues to turn to digital health, AI
While the industry continues to embrace digital health and artificial intelligence, there are still questions about how the new technologies and services need to be regulated and if they are effective.
By MedTech Dive staff -
titoOnz via Getty Images
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 -
Joe Raedle via Getty Images
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 -
artJazz via Getty Images
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 -
Mario Tama via Getty Images
‘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 -
Drew Angerer/Getty via Getty Images
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 -
Sasirin Pamai via Getty Images
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 -
Patrik Stollarz / Staff via Getty Images
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 -
iStock via Getty Images
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 -
the rads via Getty Images
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 -
Wavebreakmedia via Getty Images
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 -
Sarah Silbiger via Getty Images
FDA breakthrough device designations fall in Q3 but record year still within reach
If activity accelerates after the summer months, the agency will post another record year for designations.
By Nick Paul Taylor • Oct. 31, 2022 -
Courtesy of Baxter/Hillrom
Baxter warns hospitals to stop using connected incontinence pads over interference risk
The interference may affect insulin pumps, fetal monitors, telemetry devices, bladder scanners and infusion pumps.
By Nick Paul Taylor • Oct. 27, 2022 -
Sarah Silbiger via Getty Images
Accelerate Diagnostics withdraws BD-partnered device after FDA demands 510(k) clearance
An analyst said they were “somewhat surprised” by the FDA’s decision as “Arc does not directly lead to a patient result.”
By Nick Paul Taylor • Oct. 25, 2022 -
Courtesy of Abiomed
Abiomed wraps up Impella post-approval studies requested by FDA
Abiomed’s studies linked the device to a 22% to 45% improvement in the volume of blood pumped after 90 days, suggesting it’s a viable alternative to balloon therapy.
By Nick Paul Taylor • Oct. 21, 2022 -
adamkaz via Getty Images
FDA moves to make effect on health equity part of breakthrough device considerations
If it finalizes the proposal, the agency will expand its breakthrough program to devices that improve accessibility.
By Nick Paul Taylor • Oct. 21, 2022 -
Brendan Hoffman via Getty Images
Testing overhaul faces a ‘narrow pathway’ to pass before year end, industry groups say
Despite bipartisan support, a bill to allow the FDA to regulate lab-developed tests still faces hurdles to inclusion in an omnibus spending package.
By Elise Reuter • Oct. 20, 2022 -
Sarah Silbiger via Getty Images
FDA seeks feedback on plans to draft and finalize medical device guidance in 2023
The agency’s review includes guidance on transitioning away from emergency use authorizations, while abandoning plans for guidance on software as a medical device.
By Nick Paul Taylor • Oct. 19, 2022 -
Courtesy of Lucid
Lucid enters OTC hearing aid market, undercutting rivals with devices starting at $200
Lucid joins Sony and the Bose-partnered Lexie Hearing with aids priced thousands of dollars below prescription devices, putting auditory assistance within reach of tens of millions of Americans.
By Nick Paul Taylor • Oct. 18, 2022 -
FatCamera via Getty Images
Coloplast told by FDA to keep transvaginal mesh off market after 36-month surveillance study
The mesh provides similar effectiveness and safety outcomes to native tissue repair but also comes with additional risks, regulators concluded.
By Nick Paul Taylor • Oct. 18, 2022
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