Medical Devices: Page 194
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Gottlieb: UnitedHealth, CareFirst sign onto FDA pilot aiming to speed device coverage
The FDA chief also outlined new programs including "QUiK Review" aimed at cutting review times for low-risk 510(k) submissions "by as much as 30%."
By David Lim • Sept. 5, 2018 -
Developing afib after valve implant raises risks, study finds
Just a third of patients who developed atrial fibrillation after a transcatheter aortic valve replacement procedure got oral anticoagulation medication at discharge, according to a Duke University study.
By Susan Kelly • Sept. 5, 2018 -
Explore the Trendline➔
Courtesy of Intuitive Surgical
TrendlineTop 5 stories from MedTech Dive
From the top medtech trends to watch in 2026 to haphazard layoffs at the Food and Drug Administration and the evolving use of AI in the medtech sector, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
Montgomery County Planning Commission
Aetna to cover Abbott's non-opioid pain implant Proclaim
The decision opens up a potential market of 22 million people for the neurostimulation device.
By Nick Paul Taylor • Sept. 5, 2018 -
Otsuka rolls out Abilify digital pill through Magellan network
The digital pill will cost $1,650 for a 30-day supply, which includes the wearable sensor and MyCite app, according to the company.
By Susan Kelly • Sept. 4, 2018 -
European Society of Cardiology endorses iFR in guidelines
Royal Philips obtained the technology in its 2015 acquisition of Volcano Corp.
By Susan Kelly • Sept. 4, 2018 -
UK sketches medtech future under no Brexit deal
With six weeks before a key deadline, the government seeks to ease the transition between old and new regulatory regimes but is unlikely to fully mitigate the impact.
By Nick Paul Taylor • Sept. 4, 2018 -
Deep Dive
FDA rarely uses its power to recall dangerous medical devices. Why not?
"Once products are on the market, it's almost an insurmountable threshold to get the agency to take action to pull them from the market," Public Citizen's Michael Carome said.
By Meg Bryant • Aug. 31, 2018 -
Pressure builds on HHS to issue interoperability rule
"Expansion of API coverage should be carefully profiled and tested by the vendor community before becoming a regulatory requirement," says Cerner's John Travis.
By Meg Bryant • Aug. 31, 2018 -
Stryker buys spine device maker K2M for $1.4B
The acquisition is expected to give Stryker some needed heft in the category, adding several differentiated products in faster-growth areas of the specialty.
By Susan Kelly • Aug. 31, 2018 -
Medtronic cryoballoon reduces persistent afib symptoms in study
The ablation device uses cold energy to interrupt irregular electrical signals in the heart in a minimally invasive procedure.
By Susan Kelly • Aug. 31, 2018 -
Philips licenses Air Force mobile patient monitoring technology
The Andover, Massachusetts-based medtech giant plans to leverage the wearable system for telemedicine purposes.
By Meg Bryant • Aug. 31, 2018 -
Alcon withdraws glaucoma device amid long-term safety concerns
Five-year data linked the stent to increased endothelial cell loss.
By Nick Paul Taylor • Aug. 30, 2018 -
Gottlieb hails early breakthrough device successes, plans AI benchmarks
The commissioner set out how the FDA is accelerating the development of medical devices.
By Nick Paul Taylor • Aug. 30, 2018 -
SynCardia stands behind its artificial heart driver
The Companion 2 driver that supports SynCardia's temporary Total Artificial Heart has not been identified as the root cause of increased mortality and stroke rates in a post-approval study, the company told clinical partners.
By Susan Kelly • Aug. 29, 2018 -
Balloons as effective as stents to open small arteries, study says
The study is the largest randomized trial to look at whether drug-coated balloons are as effective as drug-eluting stents, according to the researchers.
By Susan Kelly • Aug. 29, 2018 -
NIH-backed trial links device to drop in cardiac arrest deaths
The study found patients were more likely to survive after treatment with laryngeal tubes.
By Nick Paul Taylor • Aug. 29, 2018 -
FDA warns Zimmer Biomet about quality violations at Indiana plant
The former Zimmer Holdings has struggled to integrate Biomet since acquiring its cross-town rival for $13 billion in 2015.
By Susan Kelly • Aug. 28, 2018 -
Wright Medical inks $435M takeover of implant firm Cartiva
An arthritis implant with fast-growing sales is the focal point of the acquisition.
By Nick Paul Taylor • Aug. 28, 2018 -
DexCom acquires maker of insulin dosing algorithm
The company expects the first commercial launch of an automated insulin delivery system using TypeZero's inControl algorithm in 2019.
By Susan Kelly • Aug. 27, 2018 -
Patients getting needed supplies under DME bidding: GAO
The GAO found that the number of durable equipment suppliers decreased 8% in 2016, consistent with the years before the rate adjustments went into effect.
By Susan Kelly • Aug. 27, 2018 -
Hands-free device may track astronauts' vital signs in space
The camera analyzes pulsations in the blood vessels of a person's face to track heart beats and respiration rates.
By Susan Kelly • Aug. 27, 2018 -
Robotic surgery market is about to get crowded, report says
GlobalData predicts larger companies will accelerate investment in surgical robotics through acquisitions and partnerships.
By Susan Kelly • Aug. 24, 2018 -
How TraceLink will use $93M in new funds to showcase the benefits of serialization
The data network plans to expand into a life sciences software suite to help pharmaceutical supply chains tap into data that was unavailable prior to track-and-trace regulations.
By Edwin Lopez • Aug. 23, 2018 -
FDA posts guidance on endpoints in osteoarthritis trials
The draft guide says more research is needed before the agency accepts structural endpoints.
By Nick Paul Taylor • Aug. 23, 2018 -
Gynesonics gets FDA nod for fibroid ablation device
The minimally-invasive device uses radiofrequency to reduce the volume of uterine fibroids.
By Nick Paul Taylor • Aug. 23, 2018
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