Medical Devices: Page 173
-
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 -
Dollar Photo Club
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 -
Explore the Trendline➔
Sitthiphong via Getty Images
TrendlineMedical device industry continues to turn to AI
While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.
By MedTech Dive staff -
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 -
Getty Images
Deep DiveFDA 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 -
Credit: Andrew Propp, FDA / Edited by BioPharma Dive
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 -
Adobe Stock
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 -
Getty Images
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 -
Adobe Stock
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 -
Adobe Stock
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 -
Getty Images
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 -
Jacob Bell
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 -
NIST offers guide to securing wireless infusion pumps
Several companies worked with the agency to develop the guide, including B. Braun Medical, Baxter, Becton Dickinson and Cisco.
By Susan Kelly • Aug. 22, 2018 -
FDA extends EpiPen expiration date to ease shortages
Current supply issues stemming from ongoing manufacturing delays could put children at risk as the school year approaches.
By Suzanne Elvidge • Aug. 22, 2018 -
Medicare overpaid millions for outpatient planning services
A report from the HHS Office of Inspector General blamed the excessive payments for intensity-modulated radiation therapy planning services mostly on hospitals not knowing or misinterpreting CMS guidance.
By Les Masterson • Aug. 21, 2018
Previous
