Medical Devices: Page 174
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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 -
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 -
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 -
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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 -
Jacob Bell / BioPharma Dive
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 -
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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 -
Novo Nordisk
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 -
Jacob Bell
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 -
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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 -
AdvaMed pushes back against FDA humanitarian device guidance
The trade group thinks the guidance will deter development of devices to treat rare conditions.
By Nick Paul Taylor • Aug. 15, 2018 -
With Mylan reeling, Kaléo touts its EpiPen rival for back-to-school season
Manufacturing delays at a Pfizer-owned EpiPen plant have created an opportunity for Kaléo.
By Nick Paul Taylor • Updated Aug. 15, 2018 -
BARDA, J&J team to crowdsource respiratory device ideas
The HHS arm will work with the drugmaker's JLabs, which runs a program challenging scientists, companies and entrepreneurs to come up with bankable ideas.
By Susan Kelly • Aug. 14, 2018 -
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FDA approves one-year contraceptive ring
The product, developed by the nonprofit Population Council, will be made available in the U.S. through a license agreement with women's health company TherapeuticsMD.
By Susan Kelly • Aug. 14, 2018 -
Jacob Bell
FDA sets out vision to use real-world data in product evaluations
The agency wants insights into safety and efficacy outside of controlled research environments.
By Nick Paul Taylor • Aug. 14, 2018 -
Deep Dive
Medical device industry caught in US-China trade war
"If this keeps escalating … a tit-for-tat game without any end in sight, that's very concerning to our industry and ultimately to patient care," a top industry imaging official said.
By Meg Bryant • Aug. 13, 2018 -
NuVasive, Siemens partner on spine surgery imaging
Makers of spinal fusion devices are looking to differentiate themselves in a crowded market.
By Susan Kelly • Aug. 13, 2018 -
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Most recalled foot, ankle devices are 501(k) approved, study finds
The less-demanding 510(k) process "may cause the devices to carry a greater risk to patients" due to a lack of clinical data, researchers said.
By Susan Kelly • Aug. 13, 2018 -
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FDA OKs marketing of contraceptive app
The Natural Cycles app has generated controversy in Europe, where women have reported unplanned pregnancies while using it.
By Susan Kelly • Aug. 13, 2018 -
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Burn treatment earns expanded compassionate use approval
The suspension offers a way to achieve permanent closure in burns and other wounds while reducing the amount of skin harvested at the time of surgery.
By Susan Kelly • Aug. 10, 2018 -
Medtronic begins study of ICD with leads outside the heart
The device, called the Extravascular Implantable Cardioverter Defibrillator, will provide the same therapies as traditional transvenous ICDs.
By Susan Kelly • Aug. 10, 2018
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