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➔

Medical 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

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Such devices may sound like science fiction, but in conjunction with a draft guidance on the topic, Commissioner Scott Gottlieb called the possibility within reach.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

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

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