Medical Devices: Page 165
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Insulet, Tandem ride wave of diabetes tech
Tandem Diabetes' shares climbed more than 25% Wednesday after reporting a 102% bump in insulin pump shipments last year. Pure-play and diversified medtechs alike are enjoying uptake of newer technologies.
By Maria Rachal • Updated Feb. 27, 2019 -
FDA warns breast infrared imaging tool should not replace mammography
Total Thermal Imaging's thermography system has not been cleared as a standalone diagnostic tool, and the technology lacks scientific evidence to support its use in breast cancer screening, the agency said.
By Susan Kelly • Feb. 26, 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 -
Verily launches eye disease screening algorithm in India
The company also said the algorithm won CE mark approval, but did not reveal its plans for the technology in Europe.
By Susan Kelly • Feb. 26, 2019 -
Stryker buys Arrinex to expand ENT portfolio
The takeover gives Stryker's growing ENT business a chronic rhinitis device.
By Nick Paul Taylor • Feb. 26, 2019 -
Biotronik's drug-eluting stent expands to US market with PMA
The Orsiro system for coronary artery disease will play against Abbott's Xience and Medtronic's Resolute.
By Maria Rachal • Feb. 25, 2019 -
Prosthetics controlled by brain implants in the offing, FDA says
Such devices may sound like science fiction, but in conjunction with a draft guidance on the topic, Commissioner Scott Gottlieb called the possibility within reach.
By David Lim • Feb. 25, 2019 -
OneLife, AT&T partner on health-tracking watch
With Apple, Fitbit and Samsung all fighting for market share, the company will face competition to break into the space.
By Meg Bryant • Feb. 25, 2019 -
Deep Dive
Neuromodulation market expands amid hunt for opioid alternatives
Stigma, cost and risk of surgery don't seem to be stopping growth of devices that target nerve activity central to diseases like Alzheimer's, epilepsy and chronic pain.
By Meg Bryant • Feb. 22, 2019 -
Improper inhaler use common among majority of asthmatics: study
Research funded by digital therapeutics company Propeller Health — recently picked up by ResMed — used sensors attached to inhalers to find 84% of asthmatics may not properly administer their medication.
By Maria Rachal • Feb. 22, 2019 -
FDA rule on device study practices comes into force
The final rule mandates the use of good clinical practices by sponsors of trials based outside the U.S.
By Nick Paul Taylor • Feb. 22, 2019 -
Japan agrees to reimburse LivaNova's sutureless aortic heart valve
The insurance coverage decision should help the company grow sales of its Perceval device.
By Nick Paul Taylor • Feb. 22, 2019 -
Philips' camera-guided digital imaging system gets FDA OK
The nod comes after Philips reported fourth quarter growth in image-guided therapy, ultrasound and diagnostic imaging.
By Meg Bryant • Feb. 21, 2019 -
First commercial epilepsy patient gets Medtronic deep brain stimulation device
The device, which received premarket approval from FDA in April, aims to reduce how often patients experience partial-onset seizures by delivering electrical stimulation to certain areas in the brain.
By David Lim • Feb. 21, 2019 -
Abbott and Novo Nordisk plan to link diabetes devices
The connected insulin dosing pens from Novo Nordisk will share data with digital platforms connected to Abbott's FreeStyle Libre continuous glucose monitoring system, though the partnership is non-exclusive.
By Maria Rachal • Feb. 21, 2019 -
Durable medical equipment spending to spike $36.9B by 2027, CMS says
The projected growth in durable medical equipment spending comes as CMS continues to implement a potentially costly overhaul of its coverage for DME.
By Rebecca Pifer • Feb. 20, 2019 -
Swiss regulator weighs in on textured breast implants
Swissmedic is the latest national authority to flag a lymphoma that may be tied to breast implants.
By Susan Kelly • Feb. 20, 2019 -
Intuitive gains FDA clearance for Ion lung catheter
The robot-assisted surgery pioneer said it plans a measured U.S. rollout of the system with customer shipments beginning in the second quarter.
By Susan Kelly • Feb. 20, 2019 -
Medtronic and J&J lost spine share to pure-play rivals in Q4, analysts say
Globus Medical, NuVasive and Stryker's K2M drew business away from the medtech giants, mirroring a trend seen the past two years.
By Nick Paul Taylor • Feb. 20, 2019 -
FDA grants breakthrough status to concussion-detecting VR headset
The SyncThink device analyzes the wearer's eye movements. The medtech has deals with the Golden State Warriors and hospitals including Mass General.
By Nick Paul Taylor • Feb. 20, 2019 -
FDA proposes new channel for giving feedback on inspections
The agency is looking to create a process for providing nonbinding feedback to medical device companies that it expects to help speed corrective actions on safety and quality issues.
By Susan Kelly • Feb. 19, 2019 -
FDA clarifies pathway for devices used in regenerative medicine
The final guidance document covers instruments, machines and implants used in conjunction with cell-based and gene therapies.
By Susan Kelly • Feb. 19, 2019 -
Medtronic recalls pacemakers due to software error
The medtech giant is recalling 13,440 of the devices in the United States because the defect could result in a break in pacing function.
By Susan Kelly • Feb. 19, 2019 -
Medtronic posts beat-and-raise Q3 despite tumbling heart failure sales
Heart failure sales fell more than 40% as Abbott's HeartMate 3 took a big chunk of market share. Separately, the company reported FDA breakthrough designation for its personalized closed loop insulin pump system.
By Nick Paul Taylor • Feb. 19, 2019 -
Deep Dive
4 main takeaways from HIMSS19
Digest the biggest health IT conference of the year with this roundup of what grabbed the attention of more than 43,000 health execs, policymakers and academics.
By David Lim , Rebecca Pifer • Feb. 15, 2019 -
FDA orders doctor to stop marketing unapproved breast augmentation device
The warning letter comes amid increased scrutiny of breast implants by regulators globally, with reported cases of adverse events linked to the devices on the rise.
By Susan Kelly • Feb. 15, 2019
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