Medical Devices: Page 50
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Permission granted by Zimmer Biomet
Zimmer Biomet promotes 3 executives
The appointments come less than a month after the company elevated Ivan Tornos to the CEO position.
By Susan Kelly • Sept. 7, 2023 -
N/A via Getty Images
Philips reaches settlement in US respiratory device litigation
The company will pay more than $479 million to resolve all economic loss claims. The settlement does not include injury or medical monitoring claims.
By Elise Reuter • Sept. 7, 2023 -
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 U.S. Food and Drug Administration
FDA proposes 3 guidances to improve 510(k) clearance process
The agency has made recommendations for selecting predicate devices, using clinical data and conducting performance testing for implants.
By Nick Paul Taylor • Sept. 7, 2023 -
Courtesy of Boston Scientific
Boston Scientific gets FDA nod for latest device in fast-growing Watchman franchise
Analysts at RBC Capital Markets called the Watchman FLX Pro approval an “incremental positive” for Boston Scientific.
By Nick Paul Taylor • Sept. 7, 2023 -
Permission granted by Synchron
Synchron brain-computer interface implanted in first 6 US patients
The device is intended to give people with severe paralysis the ability to use their thoughts to perform everyday functions, such as online communications, hands-free.
By Susan Kelly • Sept. 6, 2023 -
Permission granted by Bigfoot Biomedical
Abbott to buy smart insulin pen cap maker Bigfoot
The planned acquisition could shift patients interested in smart pens to Abbott’s Libre CGMs, an analyst wrote.
By Elise Reuter • Sept. 6, 2023 -
Permission granted by Illumina
Illumina names Agilent’s Jacob Thaysen as its next CEO
The appointment comes less than three months after former CEO Francis deSouza stepped down following a proxy battle.
By Susan Kelly • Sept. 5, 2023 -
Courtesy of Medtronic
Medtronic sued for allegedly sharing ‘treasure trove’ of diabetes patient data with Google
The plaintiff said disclosures to Google are “particularly problematic” because his use of Gmail meant his personal information was “automatically linked to his real identity.”
By Nick Paul Taylor • Sept. 5, 2023 -
Permission granted by Noah Medical
Noah Medical lung biopsy robot exceeds expectations in first-in-human trial
The startup presented early data on its FDA-cleared system at a meeting of pulmonologists in Chicago.
By Susan Kelly • Sept. 1, 2023 -
HadelProductions via Getty Images
Spine volumes to grow 6.5% next year as post-pandemic boost continues: analysts
Use of robotic systems in spine surgeries also is on the rise, according to the latest poll by BTIG.
By Nick Paul Taylor • Sept. 1, 2023 -
Permission granted by ZimVie
Q&AZimVie’s Rebecca Whitney sizes up the competition in cervical disc implants
The company is bringing new products to market as it faces more challengers in cervical disc replacement and tethering for scoliosis.
By Elise Reuter • Sept. 1, 2023 -
Courtesy of Beta Bionics
Beta Bionics raises $100M to challenge Medtronic, Tandem for automated insulin dosing market
The company’s iLet Bionic Pancreas automates insulin dosing without requiring mealtime carb counting.
By Nick Paul Taylor • Sept. 1, 2023 -
Courtesy of Abbott
Abbott study shows benefits of OCT imaging in stent placement
Optical coherence tomography improved doctors’ ability to place stents, but the study did not meet its primary goal for reducing a composite of deaths, heart attacks and repeat procedures.
By Susan Kelly • Aug. 31, 2023 -
SHansche via Getty Images
UK regulators name 3 approved bodies to ease device certification bottleneck
A MHRA leader hailed the action as “almost doubling capacity for medical device assessment in the U.K.”
By Nick Paul Taylor • Aug. 31, 2023 -
Courtesy of Hamilton Medical
Hamilton Medical’s urgent ventilator notice deemed Class I recall by FDA
The company contacted customers in June after learning that long-term use of the devices could cause them to stop providing active ventilation.
By Nick Paul Taylor • Aug. 31, 2023 -
Ethan Miller via Getty Images
Deep DiveWhy medtech firms are putting diabetes tech in consumer devices
As Abbott develops a line of wearable wellness devices, and Dexcom makes a CGM for people with diabetes who don’t take insulin, both companies are turning to new users for future growth.
By Elise Reuter • Updated Aug. 31, 2023 -
iStock via Getty Images
Trade groups urge CMS to expand, quickly finalize breakthrough device pathway
The groups want changes that include expanding the program to cover breakthrough diagnostics and previously authorized products.
By Nick Paul Taylor • Aug. 30, 2023 -
magicmine via Getty Images
GE HealthCare rolls out software to speed assessment of AFib patients
The program aims to cut the time physicians spend searching multiple systems to understand the cardiac history of AFib patients.
By Nick Paul Taylor • Aug. 29, 2023 -
Photo by Anna Tarazevich from Pexels
Hopes dim for Medtronic hypertension treatment after FDA panel rebuff
Analysts foresee hurdles to reimbursement even if the device wins the agency’s nod, and some don’t expect approval at all.
By Susan Kelly • Aug. 29, 2023 -
Courtesy of https://news.medtronic.com/Left-Ventricular-Assist-Device-For-Advanced-Heart-Failure#assets_34137_10-122:19299
Medtronic identifies patients at increased risk of heart pump failure
The company has recalled its HeartWare HVAD pump multiple times since it was pulled from the market in 2021.
By Elise Reuter • Aug. 29, 2023 -
Courtesy of 3M.
3M reaches $6B settlement to resolve combat earplug lawsuits
The agreement is much less than the $10 billion forecast by analysts.
By Nick Paul Taylor • Aug. 29, 2023 -
Permission granted by Boston Scientific
Boston Scientific’s pulsed field ablation device matches standard of care in AFib trial
RBC analysts forecast “conversion of 80% to 90% of the market over a 2-3 year period” after seeing the Farapulse data.
By Nick Paul Taylor • Aug. 28, 2023 -
Justin Sullivan/Getty Images via Getty Images
US signs consent decree requiring EPA to finalize ethylene oxide rule by March
A medtech trade group called the deadline inadequate for the EPA to complete the “substantial” work that remains.
By Nick Paul Taylor • Aug. 28, 2023 -
DigitalVision Vectors via Getty Images
VC funding in medtech ticks up, raising hopes that slump has bottomed
Analysts also forecast renewed interest in M&A now that large companies have worked through a string of spinoffs.
By Nick Paul Taylor • Aug. 25, 2023 -
Permission granted by Cydar Medical
Medtronic’s endovascular artificial intelligence pilot program treats first patient
A physician in the pilot used a 3D map of patient tissue in the image-guided minimally invasive surgery.
By Nick Paul Taylor • Aug. 25, 2023
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