Medical Devices: Page
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Moody's warns medtech is highly vulnerable to cyberattacks
The credit rating agency said impact of an attack would still not rival the severity of one on the broader healthcare industry.
By Nick Paul Taylor • March 1, 2019 -
Gottlieb pledges device, drug reviews will be on time post shutdown
The FDA chief's appearance before Congress comes a day after a bill was introduced to allow the agency to accept new medical device applications and user fees during a government shutdown.
By David Lim • Feb. 28, 2019 -
Explore the Trendlineā
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TrendlineTop 5 stories from MedTech Dive
From the effects of layoffs at the Food and Drug Administration and President Donald Trump’s tariff policies to the top medtech trends of 2026, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
Boston Scientific Lotus matches Medtronic CoreValve in head-to-head TAVR trial
The readout comes as Boston Scientific prepares to introduce its device in the U.S. and Europe.
By Nick Paul Taylor • Feb. 28, 2019 -
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 -
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 -
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 -
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 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
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