Medical Devices: Page 158
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Scientists propose universal standard to calibrate CT scanners
The measurement approach could improve comparison of scans from different machines, potentially making diagnosis more efficient and less costly.
By Susan Kelly • March 4, 2019 -
As robotic surgery booms, FDA cautions against use for cancer
Agency leaders cited lack of evidence on safety and effectiveness, but major health systems report using the tech for cancer patients.
By Maria Rachal • March 1, 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 -
Gene test for antibiotic resistance gets FDA breakthrough nod
The World Health Organization has identified antibiotic resistance as one of the biggest threats to global health.
By Susan Kelly • March 1, 2019 -
EU debuts drug-device Q&A ahead of regulatory changes
The guidance sets out how incoming medical device regulations will affect developers of pre-filled syringes and other combination products.
By Nick Paul Taylor • March 1, 2019 -
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 -
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 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 -
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 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 -
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 -
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 -
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
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