Medical Devices: Page 76
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Courtesy of https://www.dbl-diabetes.com/wp-content/uploads/2022/03/1114x708-dblg1-system-overview-EN.jpg.webp
Diabeloop’s insulin algorithm shows 17-point rise in time-in-range from year-long patient study
About half of the people using its device achieve the recommended outcomes, versus 27% of those using standard treatment.
By Nick Paul Taylor • Sept. 22, 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 -
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 -
Courtesy of Abbott
Abbott’s FreeStyle Libre linked to 67% drop in hospitalizations for Type 2 diabetes patients: study
After switching to the continuous glucose monitor, patients had fewer acute diabetes-related events such as severe hypoglycemia and diabetic ketoacidosis.
By Nick Paul Taylor • Sept. 21, 2022 -
Courtesy of https://news.medtronic.com/MiniMed-R-670G-Hybrid-Closed-Loop-System#assets_34137_21-122
Medtronic issues urgent notice about MiniMed insulin pump system vulnerability
Unauthorized users could hack into the device while it’s being set up, and cause the pump to deliver too much or too little insulin, potentially resulting in outcomes including death.
By Nick Paul Taylor • Sept. 21, 2022 -
Mario Tama via Getty Images
J&J opens new research hub near San Francisco
The roughly 200,000-square-foot facility will house about 400 employees and more than double the size of the drugmaker’s presence in San Francisco.
By Delilah Alvarado • Sept. 20, 2022 -
Permission granted by Zimmer Biomet
Zimmer Biomet gets FDA clearance for Identity shoulder system
Ivan Tornos, the company’s chief operating officer, said in August that it would be Zimmer’s biggest shoulder launch in five years.
By Elise Reuter • Sept. 20, 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 -
Jose Jimenez via Getty Images
Hurricane Fiona unlikely to significantly disrupt medical device supply: analysts
Medtech management teams expect fewer problems than after Hurricane Maria in 2017, noting that Hurricane Fiona is less severe and companies are better prepared.
By Nick Paul Taylor • Sept. 20, 2022 -
Permission granted by Abbott Laboratories
Abbott’s latest Amulet-Watchman data show more mixed results for the heart devices
The latest head-to-head trial adds to the growing rivalry between Abbott and Boston Scientific in the left atrial appendage closure space.
By Ricky Zipp • Sept. 19, 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 -
Medtronic starts full US commercial release of updated Evolut TAVR system
Medtronic expects the device’s new features to increase its share of the multibillion-dollar heart valve replacement market.
By Nick Paul Taylor • Sept. 19, 2022 -
Courtesy of Edwards Lifesciences
Edwards gets FDA nod for mitral regurgitation treatment
The approval would bring a U.S. competitor to rival Abbott’s MitraClip device.
By Elise Reuter • Sept. 16, 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 -
Permission granted by Edwards Lifesciences
Q&AEdwards head of TAVR, Larry Wood, says more urgency needed in treating heart valve disease
Continued staffing shortages at hospitals are delaying the non-invasive aortic valve procedures for patients in need.
By Elise Reuter • 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 -
Mark Wilson/Getty Images via Getty Images
FBI warns of cyber risks from legacy medical devices
Outdated device software can put data, patient safety and hospitals’ operations at risk, the top U.S. law enforcement agency warned.
By Ricky Zipp • Sept. 15, 2022 -
Spencer Platt via Getty Images
Medtech firms increasingly positive about future as staffing, inflation pressures ease, say RBC analysts
Hospital staffing and supply chain issues are expected to improve, according to comments from Boston Scientific, J&J, Medtronic, and others.
By Nick Paul Taylor • Sept. 15, 2022 -
sudok1 via Getty Images
Medtronic reports two deaths related to endotracheal tube recall
The company also received reports of three injuries related to airway obstruction with the tubes, adding to the company’s recent recall woes.
By Elise Reuter • Updated Sept. 14, 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 -
Sony partners with hearing aid specialist to enter new over-the-counter market
Sony has identified the U.S. regulatory change as a chance to use its brand and audio technology to add a new growth driver to its portfolio.
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 -
Retrieved from Catheter Precision website on September 13, 2022
Catheter Precision agrees to reverse merger, securing cash to target cardiac electrophysiology market
By merging into Ra Medical Systems, Catheter Precision has access to public markets and a pool of cash needed to bring its product to market.
By Nick Paul Taylor • Sept. 13, 2022 -
Retrieved from Titan on September 12, 2022
Medtronic signs development deal with surgical robot-maker Titan Medical
Medtronic placed a $2.6 million order for some of the company’s instruments and cameras, and its interest in Titan should help the smaller firm as it seeks to win approval for its device and market it globally.
By Elise Reuter • Sept. 12, 2022
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