FDA: Page 28
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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 -
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 -
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 -
Courtesy of Grail
Judge rules in favor of Illumina-Grail merger, countering FTC concerns
A ruling by a federal administrative judge makes it more likely Illumina can keep control of its one time subsidiary, which makes cancer tests. A European Union anti-competition review is still pending.
By Ricky Zipp , Elise Reuter • Updated Sept. 2, 2022 -
Sascha Schuermann via Getty Images
Baxter gets 510(k) clearance for syringe pump, spurring optimism of faster FDA review process
Syringe pumps are a potential new driver of growth for Baxter, and analysts at J.P. Morgan called the clearance “a nice win for the company,” as FDA timelines for pumps more broadly have remained “a challenge” for medtech companies.
By Nick Paul Taylor • Sept. 1, 2022 -
Retrieved from Integra Life on August 24, 2022
Malfunctioning Integra intracranial monitor was used on patient who died: FDA
The team caring for the patient had to replace the sensor in a malfunctioning monitor, but Integra determined that the death was unrelated to the device, the agency said.
By Nick Paul Taylor • Sept. 1, 2022 -
Retrieved from Hamilton website on August 30, 2022
Recall Watch: Hamilton ventilator, Intera pump recalls get Class I label from FDA
The FDA assigned the recalls to its most serious risk category in light of the potential for serious injuries and deaths.
By Nick Paul Taylor • Aug. 30, 2022 -
Patrik Stollarz / Staff via Getty Images
Philips recalls some BiPAP machines because of contaminated plastic
The FDA said the latest action is not associated with the company’s sleep apnea machine recall, although some devices are affected by both.
By Ricky Zipp • Aug. 29, 2022 -
John Moore / Staff via Getty Images
FDA takes N95 respirators off medical device shortage list
Respirators were one of the first medical devices identified as being in critical shortage during the COVID-19 public health emergency, the agency said.
By Ricky Zipp • Aug. 29, 2022 -
Courtesy of Medtronic
Medtronic gets CE mark for drug-eluting stent and kicks off European launch
Medtronic calculated that changes to the stent resulted in a 16% improvement in drug deliverability.
By Nick Paul Taylor • Aug. 25, 2022 -
Retrieved from Abbott.com on August 24, 2022
Abbott wins FDA approval for spinal cord stimulation treatment of multi-site pain
The approval gives Abbott a new angle as it seeks to win market share from Boston Scientific, Medtronic and Nevro.
By Nick Paul Taylor • Aug. 24, 2022
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