Medical Devices: Page 157
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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 -
Explore the Trendline➔
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 -
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 -
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 -
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 -
CMS pushes back 2021 DME bidding program window to July
The Competitive Bidding Implementation Contractor released a 55-page guide and 18 additional fact sheets with instructions for the 2021 bidding round.
By David Lim • May 8, 2019 -
FTC judge upholds unraveling of microprocessor prosthetic knee firms deal
Ottobock must sell off its recent acquisition of microprocessor prosthetic knee maker Freedom Innovations over FTC's market concentration concerns.
By Dana Elfin • Updated May 8, 2019 -
FDA finalizes laser guidelines, rebuffing calls for harmonization
The agency acknowledged the advantages of harmonization but will continue to enforce its own standards for now.
By Nick Paul Taylor • May 8, 2019 -
Verily's nanoparticle diagnostic program evolves into Verve partnership
Alphabet's life sciences research arm was initially interested in nanoparticle diagnostics but thinks the program has therapeutic potential.
By Nick Paul Taylor • May 8, 2019 -
Allergan breast implant sales drop more than 30% in Q1
Company executives downplayed the dent to the medical aesthetics unit to investors, noting that 70% of its breast implants are sold in the U.S., where the majority used feature a smooth surface less frequently tied to a rare cancer.
By Maria Rachal • May 7, 2019 -
ACLA, AdvaMedDx, BIO call for VALID Act movement by year-end
Despite differences between clinical labs and diagnostic manufacturers, industry wants to keep the legislation at the top of mind for Congress before the election and user fee negotiations suck oxygen away from the effort next year.
By David Lim • May 7, 2019 -
Test for circulating tumor DNA wins FDA breakthrough designation
Genetic testing company Natera is developing the product to detect and quantify post-surgery ctDNA in the blood of patients already diagnosed with some types of cancer.
By Susan Kelly • May 7, 2019 -
Jacob Bell/MedTech Dive
FDA issues final guide on device submission meetings, feedback
The agency also announced it will hold a webinar on June 11 to discuss the Q-Submission program.
By Susan Kelly • May 7, 2019
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