Medical Devices: Page 182
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Hologic gets EU clearance for breast lesion localization tag
The device uses radio frequency identification to wirelessly guide surgeons to breast lesions.
By Nick Paul Taylor • Feb. 28, 2019 -
UK updates Brexit medtech advice as cliff edge exit looms
The Medicines and Healthcare products Regulatory Agency document sheds new light on the responsible person requirement and parallel importing policy.
By Nick Paul Taylor • Feb. 28, 2019 -
Explore the Trendline➔
Permission granted by Boston Scientific
TrendlineNew medical devices are reshaping the medtech industry
From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.
By MedTech Dive staff -
Medtronic ablation offerings heat up with Accurian launch
The medtech said Wednesday it received 510(k) FDA clearance and has begun the U.S. launch of a nerve ablation system targeting chronic pain.
By Maria Rachal • Feb. 27, 2019 -
Thermo Fisher lung cancer test wins expanded approval in Japan
Japan's regulatory agency approved the Oncomine DX Target test to include three additional biomarkers for non-small cell lung cancer.
By Susan Kelly • Feb. 27, 2019 -
Medtronic Resolute stent gains expanded indication
The device will now compete against Abbott's Xience for patients with a complex form of coronary artery disease known as chronic total occlusion.
By Susan Kelly • Feb. 27, 2019 -
Introduction of robotic surgery cuts endometrial cancer complications: JAMA
The study linked minimally invasive procedures to significantly fewer severe complications than open procedures.
By Nick Paul Taylor • Feb. 27, 2019 -
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 -
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 -
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 -
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 -
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 -
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 -
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 Parduhn • 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 -
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 -
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
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