Medical Devices: Page 150
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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 -
Explore the Trendlineâž”
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
Medtronic finalizes Titan Spine deal
The medtech giant will gain a portfolio of titanium interbody implants, bought for an undisclosed amount.
By Maria Rachal • Updated June 27, 2019 -
Philips, Medtronic team up to create image-guided atrial fibrillation device
The system will use Philips' dielectric imaging and navigation system to facilitate cryoablation without extensive X-ray imaging.
By Nick Paul Taylor • May 10, 2019 -
TransEnterix slumps after selling 1 robotic system in Q1
TransEnterix expects to sell more systems in the second quarter but investors reacted badly to the results, wiping 29% off the company's stock price.
By Nick Paul Taylor • May 10, 2019 -
Takeda sells TachoSil patch to J&J's Ethicon for $400M
TachoSil, a surgical patch to control bleeding, contributed $155 million in net sales to the Japanese drugmaker's coffers during fiscal year 2018.
By David Lim • May 9, 2019 -
BD lowers guidance as FDA paclitaxel alert dents prospects
The medtech expects sales of paclitaxel-coated balloons to fall 50% in the wake of FDA recommending against use of the devices.
By Nick Paul Taylor • May 9, 2019 -
Boston Scientific closes acquisition of spinal device in $465M deal
Vertiflex's decompression system, designed to reduce pain in patients with lumbar spinal stenosis, is the company's first acquisition of 2019.
By Maria Rachal • Updated June 12, 2019 -
FDA grants De Novo to device for cerebral aneurysms
The temporary coil embolization assist device can deliver better outcomes than stents and balloon remodeling, Israeli manufacturer Rapid Medical says.
By Nick Paul Taylor • May 9, 2019 -
FDA warns of rapid battery draining in some Medtronic pacemakers
One patient has died as a result of the issue. Removal of the implanted devices from patients is not recommended, but FDA advised physicians to consider whether elective device replacement is warranted for high-risk patients.
By Susan Kelly • May 8, 2019 -
FDA updates imaging rules in final guidance
The agency aims to align U.S. performance standards for X-ray imaging equipment with international policy, efforts supported by industry groups, and clarify aspects of U.S. requirements for fluoroscopic equipment.
By Susan Kelly • May 8, 2019 -
Aiming to boost transplant availability, FDA advises on organ preservation devices
A final guidance document outlines how product developers can design animal studies to evaluate machine perfusion organ preservation technologies.
By Maria Rachal • May 8, 2019
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