Medical Devices: Page 74
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Courtesy of Abiomed
Abiomed wraps up Impella post-approval studies requested by FDA
Abiomed’s studies linked the device to a 22% to 45% improvement in the volume of blood pumped after 90 days, suggesting it’s a viable alternative to balloon therapy.
By Nick Paul Taylor • Oct. 21, 2022 -
adamkaz via Getty Images
FDA moves to make effect on health equity part of breakthrough device considerations
If it finalizes the proposal, the agency will expand its breakthrough program to devices that improve accessibility.
By Nick Paul Taylor • Oct. 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 Q3 device sales slowed by supply chain pressures; COVID-19 tests exceed expectations
The company raised its earnings forecast for 2022 on the back of an expected $7.8 billion in annual sales related to COVID-19 testing.
By Elise Reuter • Oct. 19, 2022 -
Courtesy of Magnolia
BD forms co-promotion pact with Magnolia to reduce blood culture contamination
Magnolia’s blood collection device diverts the first 1.5 to 2 milliliters of blood samples that may be contaminated with flecks of skin, paving the way for more accurate diagnosis of sepsis.
By Nick Paul Taylor • Oct. 19, 2022 -
Sarah Silbiger via Getty Images
FDA seeks feedback on plans to draft and finalize medical device guidance in 2023
The agency’s review includes guidance on transitioning away from emergency use authorizations, while abandoning plans for guidance on software as a medical device.
By Nick Paul Taylor • Oct. 19, 2022 -
Courtesy of MedAlliance
Cordis to spend $235M to buy Swiss maker of alternative to paclitaxel balloons
As regulatory and sales milestones are hit, Cordis could pay up to $900 million in total.
By Nick Paul Taylor • Oct. 19, 2022 -
Courtesy of Intuitive Surgical
Intuitive’s robotic surgery volumes recovered in Q3; shares climb
As hospital staffing increased and COVID-19 wariness eased, the number of procedures performed with the company’s hallmark da Vinci system rose 20% in the third quarter from a year earlier.
By Peter Green • Oct. 18, 2022 -
Mario Tama via Getty Images
J&J touts rising procedure volumes, lowers full-year forecast on foreign-exchange concerns
Analysts said the results were an “encouraging start” to medtech earnings for the third quarter.
By Elise Reuter • Oct. 18, 2022 -
Courtesy of Lucid
Lucid enters OTC hearing aid market, undercutting rivals with devices starting at $200
Lucid joins Sony and the Bose-partnered Lexie Hearing with aids priced thousands of dollars below prescription devices, putting auditory assistance within reach of tens of millions of Americans.
By Nick Paul Taylor • Oct. 18, 2022 -
FatCamera via Getty Images
Coloplast told by FDA to keep transvaginal mesh off market after 36-month surveillance study
The mesh provides similar effectiveness and safety outcomes to native tissue repair but also comes with additional risks, regulators concluded.
By Nick Paul Taylor • Oct. 18, 2022 -
Courtesy of https://news.medtronic.com/newsroom-medtronic-hits-the-road-mobile-labs
Medtronic, in a first, secures expanded label for cardiac pacing lead
The approval is part of Medtronic’s push to expand its share of the market for cardiac conduction system pacing.
By Nick Paul Taylor • Oct. 18, 2022 -
Courtesy of Insulet Corp.
Insulet flags battery problem with Omnipod DASH system
The company is expected to spend $35 million to $45 million replacing all of its personal diabetes manager devices after reports that batteries in the handheld controller may be swelling, leaking fluid or overheating.
By Elise Reuter • Oct. 17, 2022 -
Courtesy of https://news.medtronic.com/Left-Ventricular-Assist-Device-For-Advanced-Heart-Failure#assets_34137_10-122:19299
Medtronic’s faulty HVAD controllers get an emergency-only software fix
The new controllers will be available to all healthcare providers with a patient on HVAD support, but the company cautioned that the software should only be used after previous attempts to restart the pump have failed.
By Elise Reuter • Oct. 17, 2022 -
courtneyk via Getty Images
Johnson & Johnson, Alcon agree on $75M settlement to resolve contact-lens antitrust claims
A class-action suit accused the manufacturers of violating federal antitrust law by setting the same minimum price for their lenses.
By Nick Paul Taylor • Oct. 17, 2022 -
Shutterstock/Maria Symchych
Sponsored by EsperWhy Android is the future of connected HealthTech devices
How Android can make your connected HealthTech device strategy a success.
Oct. 17, 2022 -
Retrieved from Abbott/PRNewswire on June 15, 2020
Abbott, J&J and Intuitive to lead off medtech earnings season; procedures, supply chain in spotlight
Results from the three companies are expected to shed light on how the economic slowdown is affecting procedure trends in the industry.
By Nick Paul Taylor • Oct. 17, 2022 -
South_agency via Getty Images
Hospital staff shortages spurred drop in TAVR procedures in Q3, surgeon survey shows
Staffing at hospitals is expected to remain disrupted until at least 2024, reducing the number of surgeries, more than 40% of respondents said.
By Nick Paul Taylor • Oct. 14, 2022 -
Ijubaphoto via Getty Images
Bose-partnered Lexie to launch $999 OTC hearing aid, challenging Sony, Eargo in nascent market
Lexie has matched the price of the first Sony device and is seeking to differentiate itself through the use of a rechargeable battery.
By Nick Paul Taylor • Oct. 14, 2022 -
Courtesy of Sony Electronics
Sony begins sale of OTC hearing aids with entry-level price of $999
Lower-cost, over-the-counter hearing aids are becoming available to the 70% of older Americans who need the devices but don’t have them.
By Peter Green • Oct. 13, 2022 -
GE advances healthcare spinoff plan, providing close look at workings of the unit
Localization requirements, third-party servicers, and more sophisticated data security threats are cited as risks to the healthcare unit.
By Nick Paul Taylor • Oct. 13, 2022 -
N/A via Getty Images
Philips says Q3 revenue fell, records $1.26B charge for Respironics; shares plunge
The Dutch-based medtech company remains dogged by sleep apnea machine recalls and supply chain issues.
By Peter Green • Oct. 12, 2022 -
Sarah Silbiger via Getty Images
FDA starts advisory program pilot to reduce ‘valley of death’ risk for medical devices
A plan to ensure more medical devices pass from testing to clinical application aims to help dozens of devices through the approval process each year.
By Nick Paul Taylor • Oct. 12, 2022 -
‘Do-it-yourself’ artificial pancreas system beats production-line pump in controlled trial
Type 1 diabetes patients who used a customizable, open-source artificial pancreas, an insulin pump and a Dexcom G6 CGM found it more effective at controlling blood glucose than conventional sensor-augmented insulin pumps.
By Nick Paul Taylor • Oct. 12, 2022 -
Sarah Silbiger via Getty Images
FDA finalizes postapproval study guidance in light of AdvaMed, Foundation Medicine feedback
The agency resisted calls to give sponsors more time to prepare protocols for post-approval studies.
By Nick Paul Taylor • Oct. 11, 2022 -
Retrieved from Abbott/PRNewswire on June 15, 2020
Abbott’s FreeStyle Libre 2 CGM beats fingerstick testing in independent clinical trial
Going into the study, the researchers were unsure if CGMs with optional alarms for high and low blood glucose levels benefit patients with Type 1 diabetes.
By Nick Paul Taylor • Oct. 11, 2022
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