Medical Devices: Page 47
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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 -
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Sarah Silbiger via Getty Images
TrendlineMedical device safety in spotlight after high profile recalls
From Philips’ massive recall of respiratory devices to ongoing health risks with breast implants, medical devices tied to patient harm have put a focus on product safety.
By MedTech Dive staff -
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 -
Permission granted by Zimmer Biomet
‘Business as usual’ at Zimmer Biomet despite sudden CEO change
Incoming Chief Executive Ivan Tornos could accelerate the orthopedics company’s turnaround through acquisitions and by expanding its margins, analysts said.
By Elise Reuter • Aug. 24, 2023 -
Permission granted by Medtronic
Medtronic renal denervation device hits setback at FDA panel
The agency’s outside advisers found the risks of the procedure to lower blood pressure outweighed the benefits in a narrow vote.
By Susan Kelly • Aug. 24, 2023 -
Courtesy of Draeger
Draeger’s ventilator sound insulation recall triggers FDA Class I notification
The company found concentrations of a potentially carcinogenic foam component were above acceptable levels for children.
By Nick Paul Taylor • Aug. 24, 2023 -
Courtesy of Recor
Recor wins FDA panel’s backing for high blood pressure device
The advisers found the company’s renal denervation system is safe and effective, but several panelists expressed concern about the long-term durability of the treatment.
By Susan Kelly • Aug. 23, 2023 -
Sean Gallup via Getty Images
Bayer inks deal to commercialize Mahana’s prescription digital therapeutics
The multimillion-dollar distribution and marketing partnership comes amid a decline in funding for prescription digital therapeutic companies.
By Nick Paul Taylor • Aug. 23, 2023 -
Courtesy of Levita Magnetics
Levita’s surgeon-controlled arm for magnetic procedures gains 510(k) clearance
The device maker says the technology can reduce the need for an additional assistant in the operating room, driving efficiency.
By Nick Paul Taylor • Aug. 23, 2023 -
Medtronic raises earnings forecast amid supply chain, diabetes business improvements
The company also shared an update on the planned divestment of its monitoring and respiratory interventions segments.
By Elise Reuter • Aug. 22, 2023 -
Retrieved from Axonics on August 22, 2023
Axonics appoints Kari Keese to CFO post as Dan Dearen retires
The retirement of company co-founder Dearen is “unexpected but not concerning,” Truist analyst Richard Newitter said.
By Susan Kelly • Aug. 22, 2023 -
Courtesy of 3M
Zimmer Biomet CEO Hanson departs for 3M
COO Ivan Tornos will become the orthopedic device maker’s new top executive.
By Elise Reuter • Aug. 22, 2023 -
PeopleImages via Getty Images
Bruker to buy PhenomeX and its cell research tools for $108M
The life science tools sector is ripe for consolidation, according to analysts at TD Cowen.
By Susan Kelly • Aug. 18, 2023
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