Medical Devices: Page 174
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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 -
Explore the Trendlineâž”
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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 -
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 -
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 -
Diabetes, heart device sales drive strong Medtronic Q1
Demand for the artificial pancreas, the world's first device that monitors blood glucose and administers insulin, led growth in the diabetes business.
By Susan Kelly • Aug. 21, 2018 -
FDA finds higher death, stroke rates for latest SynCardia artificial heart driver
The agency said it will work with SynCardia to ensure product labeling addresses the post-approval findings.
By Susan Kelly • Aug. 20, 2018 -
Noninvasive magnetic stimulation for OCD wins FDA nod
The agency's clearance for OCD is an extension of a 2008 approval of transcranial magnetic stimulation to treat major depression.
By Susan Kelly • Aug. 20, 2018 -
Doctors often fail to list conflicts in device studies: JAMA report
Doctors got the highest payouts from Medtronic, which accounted for more than $187.4 million, followed by Stryker and Intuitive Surgical, according to a JAMA analysis.
By Susan Kelly • Aug. 20, 2018 -
In pursuit of new insulins, Novo may drop more than $800M on Ziylo
Pricing pressures and competition have pushed diabetes drugmakers to innovate. Novo's looking to do just that in buying the University of Bristol spinout and its glucose-binding molecules.
By Jacob Bell • Aug. 17, 2018 -
FDA OKs quarterly reporting of device malfunction summaries
The change is intended to reduce regulatory burdens by lowering reporting requirements.
By Nick Paul Taylor • Aug. 17, 2018 -
Teva granted FDA approval for first EpiPen generic
It's the latest blow to Mylan, which came under fire for hiking EpiPen's price over the last decade and is now facing manufacturing challenges for the flagship product.
By David Lim • Aug. 16, 2018 -
AngioDynamics buys biopsy sealant technology from Surgical Specialties
The acquisition will expand the company’s portfolio of oncology devices.
By Nick Paul Taylor • Aug. 16, 2018 -
Medtronic starts selling drug-coated balloon in Japan
Studies have linked the device to lasting improvements in patients with peripheral artery disease.
By Nick Paul Taylor • Aug. 16, 2018 -
Healthix switching software vendors for patient matching
The nation's largest public health information exchange will switch to software vendor Verato in a bid to improve its patient-matching capabilities.
By Susan Kelly • Aug. 15, 2018
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