Medical Devices: Page 153
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Surgical instruments lead organic growth for Stryker in Q1
Despite the beat-and-raise start to 2019, Stryker posted second quarter earnings guidance that fell short of expectations.
By Nick Paul Taylor • April 24, 2019 -
Study supports genetic testing for sudden cardiac arrest
The research, published in the Journal of Cardiology, found the tests to be useful regardless of whether patients showed previous clinical evidence of heart disease.
By Susan Kelly • April 23, 2019 -
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 -
FDA advisory panels set for surgical staplers, paclitaxel devices
Regulators are seeking expert advice regarding paclitaxel-coated devices in peripheral artery disease patients, and on surgical staplers, which FDA suggests should be reclassified after a spike in adverse event reports.
By Maria Rachal • April 23, 2019 -
Obesity device to slow stomach emptying gets approval
BaroNova's clinical study met its primary endpoints for percent total body weight loss 12 months after the procedure.
By Susan Kelly • April 23, 2019 -
More patients die after starting dialysis than registry suggests: Harvard study
The death rates for dialysis patients in a new JAMA Internal Medicine analysis were almost twice as high as mortality statistics from the U.S. Renal Data Registry.
By Susan Kelly • April 23, 2019 -
Trade groups seek to guide suppliers past pitfalls of new CMS bidding process
The new lead item bidding model could lead to significant reductions in Medicare rates for medical equipment.
By Nick Paul Taylor • April 23, 2019 -
USMCA would boost medtech industry, ITC report finds
AdvaMed urged Congress to ratify the agreement "as expeditiously as possible," arguing the International Trade Commission report demonstrates it would be an improvement over the North American Free Trade Agreement.
By David Lim • April 22, 2019 -
FDA wants details on nitinol in premarket device applications
The agency aims to gather more thorough information from manufacturers in its effort to gauge the widely used metal's potential to corrode or cause allergic reactions.
By Susan Kelly • April 22, 2019 -
FDA drafts premarket recommendations for quantitative medical imaging
Data obtained through the technologies can aid in patient diagnosis, prognosis and treatment, but FDA cautioned numerical values derived from the images may be subject to multiple sources of measurement error.
By Susan Kelly • April 22, 2019 -
CDC rule removes barrier to sale of escape respirators
The deregulatory action was inspired by concern that underground coal miners could face a dangerous shortage of the breathing devices, relied on as a means of survival in emergencies.
By Susan Kelly • April 22, 2019 -
FDA clears first medical device indicated for ADHD
The De Novo-winning nerve stimulation system, which can be administered at home in certain patients ages 7 to 12 years old, serves as an alternative to prescription medication in treating attention deficit hyperactivity disorder.
By Maria Rachal • April 22, 2019 -
Intuitive shares tumble as Q1 earnings miss analyst expectations
The robotic surgery leader reported double-digit growth in procedures, shipments of surgical systems and sales, but the earnings miss reflected rising spending and lower revenues resulting from a shift to leasing.
By Nick Paul Taylor • April 22, 2019 -
Best Buy, Target jump into at-home device market
The partnership is an example of companies reaching customers through mass retailers, tightening the relationship between healthcare and retail.
By Daphne Howland • April 18, 2019 -
FDA grants breakthrough status to preeclampsia device
Advanced Prenatal Therapeutics designed the device to remove pathogenic factors from a mother's blood, seeking to prevent a pregnancy condition that can be fatal.
By Nick Paul Taylor • April 18, 2019 -
WHO weighs in on digital health tools in new report
The World Health Organization reviewed 10 digital health interventions, backing use of mobile devices for functions like clinical decision support and telemedicine. Still, a top official said the strategies are "not a silver bullet."
By Nick Paul Taylor • April 18, 2019 -
Medtronic posts data on stent grafts and venous closure systems
The endosuture aneurysm repair and chronic venous disease data suggest the efficacy seen earlier in the studies is durable.
By Nick Paul Taylor • April 18, 2019 -
FDA orders Boston Scientific, Coloplast to pull transvaginal mesh from market
The medtechs have 10 days to submit a withdrawal plan, two months after an agency advisory panel noted a worrisome lack of long-term safety and effectiveness data for the much-litigated pelvic organ prolapse repair devices.
By Maria Rachal • April 17, 2019 -
Brainlab recalls spine 3D navigation software for incorrect display
The software could display inaccurate information during a procedure that may prevent the surgeon from safely navigating surgical tools inside the patient, causing serious injury or death.
By Susan Kelly • April 17, 2019 -
AI poised to 'transform' medical imaging, radiology society says
Earlier this month FDA outlined in a white paper its vision for a framework to regulate artificial intelligence algorithms that change based on real-world learning.
By Susan Kelly • April 17, 2019 -
Abbott beats guidance in Q1, ramps up full-year earnings forecast
The medical device unit led the way once again with 5.5% growth, largely fueled by fast-rising demand for the company's FreeStyle Libre continuous glucose monitor.
By Nick Paul Taylor • April 17, 2019 -
FDA progressive device approval proposal raises eyebrows
Former FDA Commissioner Scott Gottlieb told MedTech Dive during his last week in office he believes stepwise approval should only be used for animal drugs, not human medical products.
By David Lim • April 16, 2019 -
J&J device revenue slumps amid big bet on digital surgery
Growth in contact lenses and atrial fibrillation ablation catheters were bright spots as Johnson & Johnson felt the impact of its first quarter $3.4 billion Auris Health buy and sale of the LifeScan diabetes business.
By Maria Rachal • April 16, 2019 -
FDA approves post-angioplasty dissection repair device
Intact Vascular's device is approved to treat above-knee tears in the artery wall in peripheral artery disease patients who have undergone balloon angioplasty.
By Susan Kelly • April 16, 2019 -
Edible hydrogel capsule to treat obesity gets FDA go-ahead
The De Novo-winning Plenity hydrogel capsule releases particles that rapidly absorb water in the stomach to create gel pieces with the firmness of plant-based foods, making you feel full faster.
By Susan Kelly • April 16, 2019 -
EU device group clarifies incoming database requirements
The publication of the guidelines comes as Europe races to be ready for the implementation of new medical device regulations.
By Nick Paul Taylor • April 16, 2019
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