FDA: Page 27
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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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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’ 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 -
Courtesy of https://news.medtronic.com/newsroom-medtronic-hits-the-road-mobile-labs
Medtronic, in a first, secures expanded label for cardiac pacing lead
The approval is part of Medtronic’s push to expand its share of the market for cardiac conduction system pacing.
By Nick Paul Taylor • Oct. 18, 2022 -
Joe Raedle / Staff via Getty Images
Avellino, Cepheid, GeneMatrix update COVID-19 test EUAs amid shift in FDA’s approach
COVID-19 test manufacturers have amended their fact sheets to state that diagnostics cleared or approved by the agency should be used instead of their emergency-authorized kits.
By Nick Paul Taylor • Oct. 17, 2022 -
courtneyk via Getty Images
Johnson & Johnson, Alcon agree on $75M settlement to resolve contact-lens antitrust claims
A class-action suit accused the manufacturers of violating federal antitrust law by setting the same minimum price for their lenses.
By Nick Paul Taylor • Oct. 17, 2022 -
Ijubaphoto via Getty Images
Bose-partnered Lexie to launch $999 OTC hearing aid, challenging Sony, Eargo in nascent market
Lexie has matched the price of the first Sony device and is seeking to differentiate itself through the use of a rechargeable battery.
By Nick Paul Taylor • Oct. 14, 2022 -
Courtesy of Sony Electronics
Sony begins sale of OTC hearing aids with entry-level price of $999
Lower-cost, over-the-counter hearing aids are becoming available to the 70% of older Americans who need the devices but don’t have them.
By Peter Green • Oct. 13, 2022 -
Retrieved from Jiangsu Well Biotech Co. on October 12, 2022
Jiangsu Well Biotech distributed unapproved COVID-19 tests, FDA says
The company is the latest firm to recall rapid antigen tests that had never received an emergency use authorization or clearance from the regulator.
By Elise Reuter • Oct. 12, 2022 -
Sarah Silbiger via Getty Images
FDA starts advisory program pilot to reduce ‘valley of death’ risk for medical devices
A plan to ensure more medical devices pass from testing to clinical application aims to help dozens of devices through the approval process each year.
By Nick Paul Taylor • Oct. 12, 2022 -
Scott Olson/Getty Images via Getty Images
Software to predict risk of sepsis, stroke should be regulated as a medical device, says FDA
Clarity on rules welcomed by some device makers, who also cautioned that products may take longer to come to market.
By Elise Reuter • Oct. 11, 2022 -
Sarah Silbiger via Getty Images
FDA finalizes postapproval study guidance in light of AdvaMed, Foundation Medicine feedback
The agency resisted calls to give sponsors more time to prepare protocols for post-approval studies.
By Nick Paul Taylor • Oct. 11, 2022
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