Medical Devices: Page 80
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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 • Updated Oct. 12, 2022 -
Kevin Dietsch via Getty Images
Medtech groups praise MDUFA passage as legislators plan to include reforms in end-of-year bill
The legislation will provide the FDA with as much as $1.9 billion over the next five years, but changes to diagnostics and medical device cybersecurity were slashed from a "clean version" of the bill.
By Elise Reuter • Oct. 3, 2022 -
Explore the Trendline➔
Permission granted by Boston Scientific
TrendlineNew medical devices are reshaping the medtech industry
From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.
By MedTech Dive staff -
Courtesy of Illumina
Illumina ushers in $200 genome with the launch of new sequencers
The company’s machines are part of a long line of products that have enabled Illumina to dominate the market for short-read sequencing.
By Nick Paul Taylor • 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 -
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 -
Permission granted by Philips
PhilipsPhilips shareholders officially appoint Jakobs as CEO, president
Jakobs is Philips’ chief business leader for the connected care unit and has helped with the company’s recall of millions of sleep apnea and ventilator devices.
By Ricky Zipp • Sept. 30, 2022 -
Permission granted by iRhythm Technologies
Q&AFriday Q&A: iRhythm CEO Quentin Blackford on how the heart monitor maker plans to reach $1B in sales
Continuing the company’s success in the U.S. and expanding internationally are the two biggest factors to achieving its $1 billion forecast, says Blackford.
By Ricky Zipp • 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 -
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Bionic pancreas led to lower blood sugar levels than standard of care: study
The results point to the potential for a simplified approach for automated insulin delivery that could be particularly useful for patients without regular access to an endocrinologist.
By Elise Reuter • Sept. 29, 2022 -
Sean Gallup/Getty Images via Getty Images
Cyber risks identified in Canon Medical product used to view medical images, security firm says
Vulnerabilities in Canon Medical’s Vitrea View product could provide access to patient information and other services, according to cybersecurity firm Trustwave Spiderlab.
By Ricky Zipp • Updated Sept. 30, 2022 -
Permission granted by Clik-FIX
B. Braun acquires suite of catheter securement products from Starboard medical for undisclosed amount
The six acquired devices would improve patient care and extend B. Braun’s position in IV therapy, the company says.
By Elise Reuter • Sept. 28, 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 -
VCG / Stringer via Getty Images
Hospital procedures have remained steady since H2 in boost for medtechs, survey finds
Evercore ISI analysts said the findings bode well for device companies, even as hospitals expect capital spending to drop next year.
By Elise Reuter • 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 -
Panomacc/Shutterstock.com
Sponsored by EsperPros and cons of custom devices for HealthTech use cases
To meet the needs of both your specific use case and strict regulations, should you go custom?
Sept. 26, 2022 -
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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 -
Getty Images
Forget oximeters, smartphone cameras detect 79% of cases of low blood oxygen in small study
If the results are validated by wider studies, physicians will have a new tool to increase the number of people who can be monitored for chronic and acute respiratory conditions.
By Nick Paul Taylor • Sept. 23, 2022 -
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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 -
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 -
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
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