Medical Devices: Page 159
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Zimmer Biomet narrowly beats expectations in 'good enough' quarter
Declining sales in the U.S. dragged on business in the first quarter, but management predicts improved performance in the second half of 2019, fueled in part by moving from a limited to full launch of the Rosa robotic system.
By Nick Paul Taylor • April 26, 2019 -
Jacob Bell/MedTech Dive
Manufacturers get finalized guidance from FDA on orthopaedic device material
The text is intended to help companies understand what data to submit when seeking clearance for devices made with a biomaterial commonly found in spinal implants and knee and hip replacements.
By Nick Paul Taylor • April 26, 2019 -
Explore the Trendlineâž”
Sara Silbiger via Getty Images
TrendlineTop 5 stories from MedTech Dive
From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
Mayo Clinic accelerator picks include AI, remote patient monitoring tools
Six startups were selected for the first round of a program aimed at exposing early stage medtech companies to investment and go-to-market opportunities.
By Meg Bryant • April 25, 2019 -
Falling medication delivery sales drag Baxter revenues down again in Q1
Growth at the advanced surgery unit helped offset weakness in medication delivery sales, which the company remains optimistic will grow 6% in 2019.
By Nick Paul Taylor • April 25, 2019 -
Sirolimus-eluting balloon wins breakthrough status
The designation boosts Orchestra BioMed's efforts to develop and market its Virtue device to treat below-the-knee peripheral artery disease, in addition to coronary in-stent restenosis.
By Nick Paul Taylor • Updated Sept. 17, 2019 -
Boston Scientific Q1 hit by woes over mesh, paclitaxel, sterilization
The company lowered full year revenue guidance and slashed expectations for its Eluvia paclitaxel-eluting stent by 50% ahead of an FDA advisory panel.
By Maria Rachal • Updated April 25, 2019 -
FDA pitches stronger controls, new labeling for surgical staplers
The proposed order follows an agency review that found the widely used tools were linked to numerous problems and serious complications, including 366 deaths, over a seven-year period.
By Susan Kelly • April 24, 2019 -
Edwards Lifesciences beats profit forecasts amid low-risk TAVR momentum
The structural heart-focused company posted close to $1 billion in first quarter sales, exceeding Wall Street expectations.
By Susan Kelly • April 24, 2019 -
CMS floats new add-on payment route for breakthrough devices
The agency's proposed rule for 2020 outpatient payments pitches a similar alternative pathway aimed at speeding coverage for select medical technologies.
By David Lim • Updated July 31, 2019 -
Playing catch up, Boston Scientific gets FDA approval for Lotus TAVR device
The U.S. OK comes 30 months after an issue with the delivery system locking mechanism led Boston Scientific to stop installations of the product in Europe.
By Nick Paul Taylor • April 24, 2019 -
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 -
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 -
Jacob Bell/MedTech Dive
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 -
Jacob Bell/MedTech Dive
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
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