FDA: Page 28
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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-19 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 -
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 -
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 -
Courtesy of https://news.medtronic.com/newsroom-medtronic-hits-the-road-mobile-labs
FDA updates advice about Medtronic endotracheal tubes after Class I recall, patient death reports
The FDA provided more detailed recommendations on preventing and responding to airway obstruction that may occur when using some Medtronic endotracheal tubes.
By Peter Green • Sept. 19, 2022 -
Wavebreakmedia via Getty Images
Racial bias in pulse oximeters to be subject of FDA panel
The design of the ubiquitous fingertip monitors has inadvertently caused false blood oxygen readings in darker-skinned patients, a problem the FDA hopes to fix.
By Peter Green • Sept. 16, 2022 -
Sascha Schuermann via Getty Images
Baxter’s recall of solution sets used in chemotherapy labeled Class I by FDA amid complaints of leaks
The regulator says the leaks could kill, but with 83 complaints it has not received reports of patient injuries or deaths.
By Ricky Zipp • Sept. 15, 2022 -
Retrieved from https://www.tassoinc.com/product-use-videos on September 15, 2022
Tasso’s at-home blood collection lancet wins FDA clearance
Tasso is pitching the device as an enabler of decentralized clinical trials because it could simplify the collection of blood at home.
By Nick Paul Taylor • Sept. 15, 2022 -
Courtesy of https://www.edwards.com/devices/heart-valves/transcatheter-SAPIEN-3-Ultra
Edwards updates Sapien TAVR device for greater durability
The device uses Edwards’ Resilia tissue technology to enable dry storage and potentially extend device durability.
By Nick Paul Taylor • Sept. 14, 2022 -
Investor lawsuit accuses Medtronic of failing to disclose insulin pump problems
The plaintiffs claim Medtronic failed to disclose that its product quality control systems were inadequate and that it was noncompliant with regulations.
By Nick Paul Taylor • Sept. 13, 2022 -
Mario Tama via Getty Images
J&J agrees to settle class action pelvic mesh suits in Australia for more than $200M
Shine Lawyers, the firm representing the patients, said that the Federal Court of Australia still needs to approve the terms of the agreement.
By Ricky Zipp • Sept. 13, 2022 -
Patrik Stollarz / Staff via Getty Images
Philips says French prosecutors investigating respirator recall
While the company confirmed it faces lawsuits in France, Philips said it’s too early “to speculate about any potential exposure.”
By Elise Reuter • Sept. 9, 2022 -
Courtesy of https://mitraclip.com/
FDA alerts physicians to lock malfunction with Abbott’s MitraClip heart valve device
The problem, which the FDA said occurs in 1.3% of procedures, can have consequences including the need for surgery to treat significant residual disease.
By Nick Paul Taylor • Sept. 9, 2022 -
Sarah Silbiger via Getty Images
FDA: Reports of squamous cell carcinoma, lymphomas in scar tissue around breast implants
The report adds to the history of product safety problems for breast implant devices, including patient injuries and deaths.
By Ricky Zipp • Sept. 8, 2022 -
N/A via Getty Images
French prosecutors investigating Philips Respironics recall: Reuters
In addition to a U.S. DOJ inquiry, Philips now faces an investigation from French prosecutors over its recall of sleep apnea machines and ventilators.
By Elise Reuter • Sept. 8, 2022 -
Pablo Blazquez Dominguez via Getty Images
FDA issues first EUA for monkeypox test
Quest Diagnostics' PCR test for monkeypox received emergency use authorization after the FDA issued guidance on how it will evaluate the tests.
By Elise Reuter • Sept. 8, 2022 -
Karen Ducey via Getty Images
HHS will allow EUAs for monkeypox tests to increase access in the US
The move follows the declaration of a public health emergency for the monkeypox outbreak on Aug. 4.
By Ricky Zipp • Sept. 7, 2022 -
Permission granted by Amy Cook, Magnus Med PR
FDA clears Magnus neuromodulation system in major depressive disorder
Almost 80% of people treated with the SAINT system entered remission, compared to 13% of their peers in the control group.
By Nick Paul Taylor • Sept. 7, 2022 -
Courtesy of Philips.com
Philips recalls 17M sleep apnea masks over magnets that could affect implanted devices
The problem has caused 14 serious injuries, and the FDA cautioned that the issue could lead to deaths.
By Nick Paul Taylor • Updated Sept. 8, 2022 -
Courtesy of Illumina
Illumina’s hold on Grail depends now on separate appeals in US, Europe
Even as it plans to appeal a European Commission decision and the FTC plans to appeal a U.S. ruling, Illumina say it’s preparing for ‘strategic alternatives’ to its acquisition of early cancer detection firm Grail.
By Elise Reuter • Updated Sept. 7, 2022 -
Courtesy of Grail
European Commission blocks Illumina-Grail deal to ‘preserve competition’ in cancer test market
The EC decision comes after a U.S. ruling to let the acquisition move forward and leaves Illumina facing an uncertain future in a competitive market for next-generation gene tests to detect cancer.
By Ricky Zipp • Sept. 6, 2022 -
Screenshot from WKTU TV. (2019). [Photo]. Retrieved from WKTU TV.
Federal jury convicts medtech executive in $77M blood testing kickback case
Arrayit President Mark Schena’s conviction on nine federal charges carries a maximum sentence of more than 100 years in prison.
By Nick Paul Taylor • Sept. 6, 2022 -
Kevin C. Cox via Getty Images
CDC backs updated COVID shots from Pfizer, Moderna
One day after the FDA’s authorization, the CDC recommended the companies’ omicron-targeted vaccines for most adults and children over 12 years old.
By Delilah Alvarado • Sept. 2, 2022 -
Courtesy of Vibrant Gastro
Vibrating, colon-stimulating capsule to treat chronic constipation approved by FDA
Vibrant Gastro’s drug-free capsule increased complete spontaneous bowel movements in a pivotal clinical trial, opening a new treatment pathway for the millions of Americans suffering from severe constipation.
By Nick Paul Taylor • Sept. 2, 2022 -
Patrik Stollarz / Staff via Getty Images
Philips pays $24M to settle second set of claims by US Justice Dept.
Respironics allegedly purchased, “at a significant cost to itself,” data on the prescribing decisions of U.S. physicians and gave the information to durable medical equipment suppliers so that they would promote its products.
By Nick Paul Taylor • Sept. 2, 2022
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