FDA: Page 24
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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 -
Explore the Trendline➔
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 -
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 -
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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 -
Courtesy of Abbot Molecular
Abbott lands FDA emergency authorization for first commercial monkeypox test
Abbott’s testing process is fully automated to increase throughput to help control the spread of monkeypox.
By Nick Paul Taylor • Oct. 10, 2022 -
gchutka via Getty Images
NovaSight’s digital treatment for lazy eye gets FDA nod, providing alternative to patching
A randomized controlled trial found the digital device to be as effective as wearing an eye patch, the current gold standard for treatment, opening the way for more children to complete necessary therapy for amblyopia.
By Nick Paul Taylor • Oct. 10, 2022 -
Courtesy of Owlet
Owlet seeks clearance of blood-oxygen-measuring baby sock after FDA warning letter
Owlet now is a step closer to selling a prescription medical device designed to alert parents when their baby’s heart rate or oxygen saturation levels move outside of prescribed ranges.
By Nick Paul Taylor • Oct. 10, 2022 -
Courtesy of Bayer
‘Inadequate’ progress of Bayer’s study on birth-control implant called out by FDA as patients drop out
The FDA saw a rise in patients dropping out of a study on the Essure birth-control implant, prompting it to tell Bayer to develop and implement strategies to ensure the work continues.
By Nick Paul Taylor • Oct. 7, 2022 -
Retrieved from Abbott/PRNewswire on June 15, 2020
Dexcom, Abbott have ‘massive opportunity’ with new CGM coverage proposal: analysts
Analysts at J.P. Morgan said the proposal reads “very favorably” for the two leading makers of continuous glucose monitors and unlocks “a major near-term driver for growth.”
By Nick Paul Taylor • Oct. 7, 2022 -
Courtesy of Becton, Dickinson and Company
BD discloses cybersecurity vulnerability in cervical cytology processing machine
The company is advising users to address the threat by restricting access to the instrument while it works on a software patch.
By Nick Paul Taylor • Oct. 6, 2022 -
Courtesy of Dexcom
Dexcom starts global rollout of G7 CGM system, launching device in U.K. and Germany
Software updates have delayed the introduction of the product in the U.S. at a time when the company seeks to take market share from rival Abbott.
By Nick Paul Taylor • Oct. 6, 2022 -
iStock via Getty Images
Roche wins FDA approval for companion diagnostic to support breast cancer therapy
The approval positions Roche to support the rollout of AstraZeneca and Daiichi Sankyo’s Enhertu in HER2-low breast cancer.
By Nick Paul Taylor • Oct. 5, 2022 -
Courtesy of Grail
Illumina looks to resolve Grail acquisition ‘sooner rather than later’: analysts
With a divestiture order from the European Commission looming, Illumina is looking at strategic options for the maker of blood tests used to detect cancer.
By Elise Reuter • Oct. 4, 2022 -
Courtesy of https://www.livanova.com/advanced-circulatory-support/en-us
LivaNova recall of open-heart-surgery blood pump designated as Class I event by FDA
A software malfunction can mistakenly freeze the machine, set off an alarm that can’t be muted and lead to the heart pump stopping during surgery.
By Nick Paul Taylor • Updated Oct. 12, 2022 -
Kevin Dietsch via Getty Images
Medtech groups praise MDUFA passage as legislators plan to include reforms in end-of-year bill
The legislation will provide the FDA with as much as $1.9 billion over the next five years, but changes to diagnostics and medical device cybersecurity were slashed from a "clean version" of the bill.
By Elise Reuter • Oct. 3, 2022 -
Courtesy of Illumina
European AI Act could have ‘significant impact’ on manufacturers, medtech group warns
“Overregulation and misalignment” could create uncertainty and stop products from coming to market, MedTech Europe says.
By Nick Paul Taylor • Oct. 3, 2022 -
Wavebreakmedia via Getty Images
Pulse oximeter bias delayed treatment of Black COVID-19 patients by hours: study
An author of the paper called for manufacturers to “go back to the drawing board to provide clinicians with a tool that is free from bias.”
By Nick Paul Taylor • Sept. 30, 2022 -
Spencer Platt/Getty Images via Getty Images
Veterans Affairs, FDA partner to accelerate medical device development
The goal is to provide standardized, off-the-shelf tests that can streamline the regulatory process and reduce time to market.
By Nick Paul Taylor • Sept. 30, 2022 -
Drew Angerer via Getty Images
Congress passes continuing resolution reauthorizing FDA user fees; bill heads to Biden for signature
President Biden is expected to sign last-minute deal to fund the government, that includes a “clean” bill without amendments to fund FDA review activities for five years.
By Elise Reuter • Updated Sept. 30, 2022
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