Medical Devices: Page 77
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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 -
Explore the Trendline➔
Sara Silbiger via Getty Images
TrendlineTop 5 stories from MedTech Dive
From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
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 -
Website of medical device sales form: https://spwindustrial.com/baxter-sigma-spectrum-infusion-pump-s-w-ver-8-with-dual-antenna-wireless-batt/?gclid=Cj0KCQjwpeaYBhDXARIsAEzItbFttwA55ImqoesvcmNYfm6od_td4SGgOeNOqFOQohCiU_ci1yN-oHsaAqiFEALw_wcB
Cybersecurity firm finds vulnerabilities in Baxter’s Sigma infusion pumps
The weaknesses could allow attackers to access Wi-Fi data and make the device unavailable.
By Nick Paul Taylor • Updated 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 -
Courtesy of Abbott
Abbott heart device for newborns shows longer-term benefits with three-year data
The trial results give Abbott more evidence as it seeks to position the product as an alternative to medical management or surgical ligation.
By Nick Paul Taylor • Sept. 8, 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 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 -
Medtronic recalls endotracheal tubes after reports of airway obstruction
The recall includes certain brands of Medtronic’s EMG endotracheal tubes and affects more than 600,000 devices worldwide.
By Elise Reuter • Sept. 2, 2022 -
Permission granted by iRhythm Technologies
Q&AFriday Q&A: iRhythm CTO Mark Day talks Zio Watch, Verily partnership, Big Tech in healthcare
Day spoke about developing a smartwatch for cardiac monitoring with Alphabet’s Verily, competing with Apple and building clinical evidence for the new product.
By Ricky Zipp • 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 -
Courtesy of Medtronic
Medtronic grows patient monitoring offerings with BioIntelliSense partnership
Wearable patient monitors can help with healthcare staffing shortages, an ongoing challenge for hospitals, and create an opportunity for device makers.
By Ricky Zipp • Sept. 1, 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 -
Courtesy of Invacare
Invacare drops CEO, changes board amid broader restructuring
With seven of its eight directors independent of management under an accord with its largest investor, the company is working to rebound from supply chain problems.
By Elise Reuter • Aug. 31, 2022 -
Permission granted by Becton Dickinson
Jury orders BD unit to pay $4.8M to patient in latest hernia mesh case
The award comes amid a string of defeats for major medical device makers over alleged injuries from surgical mesh products.
By Ricky Zipp • Aug. 31, 2022 -
Kuzma via Getty Images
Philips settles government claim for $4.2M over military certification of portable patient monitors
Philips conceded that it had failed to recertify the MP2 patient monitor for safe use in airplanes after modifying the devices it was supplying to the U.S. Army and Air Force.
By Elise Reuter • Aug. 31, 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 -
Retrieved from Olympus on August 30, 2022
Olympus to sell microscope unit for $3.1B as it bolsters focus on medical technology
Bain Capital has taken the other side of the deal, paying $3.1 billion for a business it said is “at the frontier of digital optical technology in life sciences and industrial end markets.”
By Nick Paul Taylor • Aug. 30, 2022 -
Courtesy of Abbott
Abbott HeartMate 3 LVAD shows improved survival rate compared to older heart pump
After five years, Abbott found that patients implanted with the HeartMate 3 LVAD had an improved survival rate compared to those implanted with the HeartMate II.
By Elise Reuter • Aug. 29, 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 -
Permission granted by Medtronic
Medtronic’s extravascular ICD meets safety, efficacy endpoints in recent study
The data could give Medtronic a competitor to Boston Scientific’s subcutaneous implantable defibrillator system.
By Elise Reuter • Aug. 29, 2022
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