Policy & Regulation
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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 -
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 -
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 • Oct. 4, 2022 -
Kevin Dietsch via Getty Images
Medtech groups praise MDUFA passage as legislators plan to include reforms in end-of-year bill
The bill will provide the FDA with as much as $1.9 billion over the next five years, but changes to diagnostics and medical device cybersecurity will have to wait until Congress returns after the mid-term elections.
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 -
Sarah Silbiger via Getty Images
FDA finalizes guidance on how clinical decision support software is regulated
The FDA has overhauled the 2019 draft, deleting some sections and completely rewriting other parts of the document.
By Nick Paul Taylor • Sept. 28, 2022 -
Drew Angerer via Getty Images
FDA switches COVID-19 tests to De Novo, 510(k) pathways, limiting EUAs
The FDA will still review EUA requests from “experienced developers” of tests that meet certain criteria.
By Nick Paul Taylor • Sept. 28, 2022 -
Stefani Reynolds via Getty Images
FDA user fees package won’t include any amendments, House leaders say
Cybersecurity and clinical trial diversity amendments passed by the U.S. House of Representatives won’t be in the final version of the bill.
By Elise Reuter • Sept. 27, 2022 -
Sarah Silbiger via Getty Images
FDA makes case for ‘new regulatory paradigm’ amid hurdles in software-oversight program
The agency seeks to tailor requirements based on the latest science, the benefits and risks posed by devices, their real-world performance and their contribution to promoting health equity.
By Nick Paul Taylor • Sept. 27, 2022 -
Sarah Silbiger via Getty Images
Puerto Rico-based lab ceases COVID-19 test; FDA revokes EUA
The FDA disclosed the action alongside updates to the instructions for use for Thermo Fisher Scientific’s TaqPath COVID-19 test.
By Nick Paul Taylor • Sept. 26, 2022 -
Patrik Stollarz / Staff via Getty Images
Philips’ latest BiPAP machine recall labeled Class I event by FDA
Certain bi-level positive airway pressure devices feature plastic that could cause machines to stop working suddenly, potentially leading to serious injury or death, the FDA said Friday.
By Nick Paul Taylor • Sept. 26, 2022 -
DNY59 via Getty Images
Device makers with ethylene oxide facilities at risk of lawsuits after Sterigenics loss: Needham
The $363 million award in the Sterigenics lawsuit “could lead to increased aggressiveness on the part of attorneys,” Needham analysts warned in a Friday note to investors.
By Ricky Zipp • Sept. 23, 2022 -
Joe Raedle / Getty via Getty Images
FDA user fee package to be included in Congress’ bill to fund government, avoid shutdown, Senators say
A “practically clean” version of the bill will allow the FDA to continue its review and testing programs, while leaving more ambitious goals to a funding bill later this year.
By Elise Reuter • Sept. 22, 2022 -
Brendan Hoffman via Getty Images
As deadline for FDA user fees bill nears, Congress weighs continuing resolution
Reauthorization bill is likely to pass before Sept. 30, but it’s unclear what provisions will be included in the final version, experts said.
By Elise Reuter • Updated Sept. 22, 2022 -
Courtesy of https://filecache.mediaroom.com/mr5mr_medtronic/183509/SURTAVI%20%28002%29%209.21%20600pix.png
Medtronic gets first FDA approval for drug-eluting stent in bifurcation lesions
Researchers have found the one-device, provisional stenting method delivers better results than two stents in some patients.
By Nick Paul Taylor • Sept. 22, 2022 -
Cameron Spencer via Getty Images
Watchdog faults FDA for rushing COVID tests to market by easing emergency use rules
HHS’ Office of Inspector General found that by loosening emergency use authorization requirements to bring COVID-19 tests to market faster, the agency allowed inaccurate tests to be distributed.
By Elise Reuter • Sept. 21, 2022 -
Courtesy of Insulet Corp.
Insulet’s Omnipod 5 gains CE Mark for European release
After months of regulatory delays, Insulet’s newest insulin pump can now be marketed in the U.S. and European Union.
By Nick Paul Taylor • Sept. 21, 2022 -
BCFC via Getty Images
Jury decides against Sterigenics in ethylene oxide trial, awarding $363M to the sole plaintiff
Sterigenics has more than 760 lawsuits pending against it in the local court for toxic emissions previously emitted by the plant.
By Nick Paul Taylor • Sept. 20, 2022
