The Latest
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Courtesy of Integra
Integra to buy Surgical Innovation Associates for $50M in bid to lead growing breast reconstruction niche
Human-derived surgical matrices dominate the market but Interga thinks synthetic and xenograft devices will gain ground.
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Courtesy of https://news.medtronic.com/Left-Ventricular-Assist-Device-For-Advanced-Heart-Failure#assets_34137_10-122:19299
Medtronic’s HVAD system recalled again amid driveline cover problems
New issues have continued to surface with the problem-plagued device even after Medtronic pulled it from the market last year.
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Courtesy of GE Healthcare
GE’s board finalizes healthcare spinoff
The new company, GE Healthcare, will be the sixth largest global medtech company when it starts trading on Nasdaq on Jan. 4.
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titoOnz via Getty Images
European biomedical group backs delaying MDR certification deadline amid ‘looming crisis’
Pushing back the recertification deadline may buy time to address problems such as the shortage of capacity at certifying organizations.
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Permission granted by Eargo
Eargo raises $32M to fight rivals in over-the-counter hearing aid market
Investment firm takes majority stake, as Eargo faces competition from new rivals including Sony and Bose-partnered Lexie.
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Permission granted by Tissium
Q&AMedTech Innovators: Tissium co-founder Maria Pereira on taking tech from bench to bedside
The MIT-trained scientist explains how she went from PhD candidate to startup founder whose company is preparing to commercialize a range of products for use in reconstructing damaged tissue.
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the rads via Getty Images
GE Healthcare, MediView XR partner to launch augmented reality X-ray imaging system
The companies are pitching the product as a response to physician demand for streamlined workflows and improved ergonomics.
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Courtesy of UroMems
UroMems starts clinical trial of smart, automated implant to treat incontinence
The device is designed to improve on products such as Boston Scientific’s AMS 800 by eliminating the need for manual adjustments.
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Courtesy of https://news.medtronic.com/newsroom-medtronic-hits-the-road-mobile-labs
Medtronic touts benefits of latest Evolut TAVR system in retrospective analysis
Changes to the device improve alignment that is associated with improved coronary blood flow and valve hemodynamic performance.
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Drew Angerer via Getty Images
Google Health licenses breast cancer detection AI to iCAD
Applying Google’s AI to breast-cancer screening algorithms may alleviate a shortage of trained physicians and enable faster tumor treatment.
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Boston Scientific to buy Apollo Endosurgery for $615M as entry into endobariatric market
The acquisition values Apollo shares at two-thirds above their closing price Monday, and may herald a new trend in medtech M&A, says an analyst.
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Courtesy of CERN
World’s largest particle physics laboratory backs push to transform cancer radiotherapy
Scientists, researchers and physicians will develop a machine to use high-speed particles to attack tumors deep inside the human body.
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Joe Raedle via Getty Images
Monkeypox to be renamed by WHO; ‘mpox’ will phase in over next year
The name change comes amid an outpouring of “racist and stigmatizing” language, the organization said.
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artJazz via Getty Images
Europe faces 2024 bottleneck in device reapprovals as submissions slow
While approval certificates for three-fourths of Europe’s medical devices will expire in 2024, a survey found no increase in the pace of submissions.
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Wavebreakmedia via Getty Images
Masimo’s pulse oximeter has no significant racial bias, study finds
The company said the result reflects its use of four additional signal processing engines that cut the impact of factors including skin pigmentation.
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N/A via Getty Images
Philips respirator recall reaches 260 reported deaths, FDA says
The agency has received 90,000 medical device reports related to foam problems with Philips’ recalled sleep apnea devices and ventilators.
Updated Nov. 23, 2022 -
Courtesy of Hillrom/Baxter
Baxter recall of connected incontinence pads ranked by FDA as Class I event
The recall was assigned to the highest risk category as it could affect medically necessary devices, including insulin pumps and fetal monitors.
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Mario Tama via Getty Images
‘Tripledemic’ concerns spur FDA to issue emergency authorization for flu-COVID-19 combination test
Experts have warned “a viral hurricane is making landfall” as cases of RSV, influenza and COVID-19 rise simultaneously.
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Permission granted by ResMed
ResMed closes $1B Medifox buyout to expand software business into Europe
The takeover gives ResMed control of a 700-person operation that offers similar solutions to its existing U.S. brands MatrixCare and Brightree.
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Permission granted by Medtronic
Medtronic lowers full-year forecast, citing drop in procedure growth
A slower-than-expected recovery in certain procedures, including TAVR and spinal cord stimulation, curbed quarterly profit and revenue.
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Courtesy of Apple
Apple earbuds show promise as hearing aids in clinical trial
The earbuds performed comparably to hearing aids in terms of speech perception in quiet environments.
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atiatiati via Getty Images
Teleflex launches another round of restructuring
Rising costs are pushing the device maker to incur restructuring liabilities of $31 million to $40 million.
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sorbetto via Getty Images
AI-powered blood test detects liver cancer, opening opportunity to improve screening
Researchers claim the blood test can double the number of liver cancer cases detected and increase early cancer detection.
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Drew Angerer/Getty via Getty Images
State AGs urge Apple to protect consumers’ reproductive health data
Apps holding sensitive health data should be required to delete nonessential information and clearly inform consumers what information they share with parties such as law enforcement, the 10 state attorneys general said.
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Sasirin Pamai via Getty Images
Zimmer lands 510(k) clearance for 3D-printed cementless knee replacement
The new joint uses anatomical data in combination with 3D printing to try to directly mimic the architecture of human spongy bone.
