Medical Devices: Page 149
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Danielle Ternes | Original photo courtesy of Rachael Fleurence
Real-world operations: NESTcc director on building a business and the future of device evaluation
The National Evaluation System for health Technology and its real-world evidence projects are finally getting off the ground. Now the center needs to secure industry's buy-in, said Rachael Fleurence, executive director.
By Maria Rachal • May 20, 2019 -
FDA warns diabetes patients against use of unauthorized devices
The agency said it received a report of a patient using a "do it yourself" management system who experienced an insulin overdose.
By Susan Kelly • May 20, 2019 -
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 -
Philadelphia jury awards $80M in J&J pelvic mesh suit
Awards in mesh cases against Ethicon in the Pennsylvania court now total $346 million.
By Susan Kelly • May 20, 2019 -
Ra Medical files suit alleging rival interfered with IPO
Separately, Nasdaq notified Strata Skin Sciences on Friday it is out of compliance with the market's continued listing requirements due to delays in filing quarterly and annual reports.
By Susan Kelly • May 20, 2019 -
Express Scripts Holding Co.
Express Scripts to launch formulary for apps, medical devices
The pharmacy benefit manager says its new formulary will include digital health solutions for a host of chronic and complex conditions, including diabetes, cardiovascular, pulmonary and behavioral health issues.
By Rebecca Pifer • May 17, 2019 -
Smiths Medical lobbies White House for better device-based opioid alternative reimbursement
The medical device industry is taking an all hands on deck approach to convince CMS for better payment in the Hospital Outpatient Prospective Payment System proposed rule.
By David Lim • May 17, 2019 -
Canada raises medical device regulatory fees
The final fee schedule reflects a compromise after industry pushed back against higher rates initially proposed.
By Susan Kelly • May 17, 2019 -
Newly independent Alcon leans on surgical unit while awaiting key product launches
The full year outlook reflects rising sales of Alcon's PanOptix intraocular lenses, offset by loss of vision care market share.
By Nick Paul Taylor • May 17, 2019 -
FDA classes J&J stapler recall as high risk ahead of advisory panel
More than 92,000 of the devices made by the pharma's Ethicon unit are implicated in the U.S. recall.
By Nick Paul Taylor • May 17, 2019 -
FDA calls Essure postmarket study progress 'adequate' in adverse event update
The agency said it received roughly 6,000 medical device reports related to the permanent birth control implant last year. Bayer halted U.S. sales at the end of 2018, but doctors can implant the device through the end of 2019.
By Maria Rachal • May 16, 2019 -
Cole Rosengren
Massachusetts grows medtech exports, but decline in clearances spurs R&D rethink
The 7.7% uptick in 2018 exports was countered by a 17% decline in 510(k) clearances.
By Nick Paul Taylor • May 16, 2019 -
Titan Medical's losses balloon as robotic surgery R&D drive accelerates
The company plans to file for a CE mark and 510(k) clearance for its robotic surgery platform by the end of the fiscal year. It aims to start early U.S. commercialization in 2020.
By Nick Paul Taylor • May 16, 2019 -
Abbott, NIH collaborate on neuroscience research
The company will contribute its neuromodulation technologies to the National Institutes of Health's work on brain disorders.
By Susan Kelly • May 15, 2019 -
Haemonetics sells plant, gains expanded indication for blood analyzer systems
After reporting a 6.7% jump in quarterly revenue, the blood technologies maker has offloaded a manufacturing site to CSL Plasma and received clearance for use of its hemostasis analyzer system in adult trauma settings.
By Susan Kelly • May 15, 2019 -
Getty Images
Medical equipment hit by escalation of US-China trade war
Between tariffs already enacted and an additional $300 billion in products on the table, imaging equipment, diagnostic reagents, surgical gloves and contact lenses stand to be among the medical devices affected.
By Nick Paul Taylor • May 15, 2019 -
CMS will weigh broader mitral valve repair NCD, analysts predict
Cowen analysts think Medicare's Coverage Analysis Group is likely to reconsider the national coverage determination for mitral valve repair in the second half of the year, which could benefit MitraClip maker Abbott.
By Susan Kelly • May 14, 2019 -
Same-day upper and lower endoscopies improve care, costs: JAMA
Johns Hopkins researchers used Medicare claims data to identify patterns suggesting overuse of different-day scheduling, especially when physician offices and freestanding ambulatory surgery centers did the scheduling.
By Susan Kelly • May 14, 2019 -
Jacob Bell
FDA extends Abiomed heart pump use to 14 days
The new label more than doubles authorized length of use of the pumps and positions physicians to give critically ill patients longer to recover before deciding on next steps.
By Nick Paul Taylor • May 14, 2019 -
Getty Images
AliveCor snags FDA clearance for six-lead EKG
Alongside an April clearance for its KardiaAI software to help identify bradycardia and tachycardia, the company is positioning itself to compete with the latest Apple Watch's electrocardiogram function.
By David Lim • May 13, 2019 -
Medtronic, Boston Scientific unveil ICD data
Medtronic also released analyses indicating implantable cardioverter defibrillators and cardiac resynchronization therapy devices are underutilized in patients medically indicated for the treatments.
By Susan Kelly • May 13, 2019 -
Dollar Photo Club
LabCorp to sell Qiagen companion diagnostic for bladder cancer
The test is designed to assess whether patients with urothelial cancer are eligible for treatment with Johnson & Johnson’s newly approved therascreen fibroblast growth factor receptor kinase inhibitor Balversa.
By Susan Kelly • May 13, 2019 -
Medicare contractors finalize narrow coverage for glioblastoma treatment
The local coverage determination for Novocure's tumor treatment field therapy will go into effect Sept. 1.
By Susan Kelly • Updated July 19, 2019 -
Flickr Creative Commons
Sen. Murray renews scrutiny of duodenoscope makers
The top Democrat on the HELP committee is asking manufacturers Olympus, Fujifilm and Pentax how they plan to respond to FDA data showing what the senator calls "alarmingly high rates of contamination."
By David Lim • Updated May 13, 2019 -
Acelity (courtesy of Maggie Fairchild)
Bound for 3M, KCI gets De Novo for negative pressure device
The clearance expands use of the negative pressure device for reduction of superficial surgical site infections in high-risk patients. The KCI brand is marketed by Acelity, acquired by 3M last week in a $6.7 billion deal.
By Maria Rachal • May 10, 2019 -
Getty
Eye scan to detect Alzheimer's biomarker gets breakthrough status
Optina Diagnostics' retinal imaging platform uses artificial intelligence to detect amyloid plaques in the brain and is intended to improve diagnostic accuracy as a non-invasive, low-cost tool.
By Susan Kelly • May 10, 2019
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