Medtronic links patients' pacemakers with their smartphones

The MyCareLink Heart mobile app is compatible with the company's BlueSync technology-enabled pacemakers and eliminates the need for other remote monitoring hardware.

By Susan Kelly • Jan. 16, 2019

FDA clears energy tools for TransEnterix robotic surgery system

The company has received FDA 510(k) clearance for a set of advanced energy instruments that can be used with its Senhance robotic surgical system.

By Susan Kelly • Jan. 16, 2019

Explore the Trendline➔

New 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

Medtech therapeutic areas to track in 2019

Cardiovascular health, diabetes and oncology diagnostics are among the products with greatest consumer and investor interest.

By Maria Rachal • Jan. 15, 2019

FDA clears absorbable foot and ankle implant

Ossio said its bioabsorbable orthopaedic fixation implant for foot and ankle conditions, made from a mineral fiber matrix, integrates into the surrounding anatomy in 18 to 24 months.

By Susan Kelly • Jan. 15, 2019

Edwards Lifesciences pays Boston Scientific $180M to settle multiple patent disputes

Edwards will make a one-time payment to Boston and the companies will drop all other patent suits and appeals related to their current portfolios of heart technologies.

By Maria Rachal • Updated Jan. 15, 2019

Abbott heart device for premature babies wins FDA approval

The device for sealing a hole in the heart of premature infants ​is smaller than a pea and can treat newborns weighing as little as 2 pounds.

By Susan Kelly • Jan. 15, 2019

Wound therapy device wins FDA authorization

The product eliminates the need to use gauze or foam when applying negative pressure to wounds.

By Nick Paul Taylor • Jan. 15, 2019

Mobile and wearable data increasingly useful to patients, JAMA authors say

Advances in internet-connected consumer devices and personal EHRs mean the systems may finally be poised to to improve patient outcomes, according to recent physician opinions published in JAMA.

By Susan Kelly • Jan. 14, 2019

Jefferies predicts upbeat 2019 medtech outlook

As the new year gets underway, the investment bank identifies growth catalysts for eight medtechs.

By Susan Kelly • Jan. 14, 2019

Senate Democrats question Gottlieb on FDA shutdown impact

FDA Commissioner Scott Gottlieb wrote Tuesday on Twitter the agency has returned 100 inspection staff to work to oversee high-risk medical device facilities.

By David Lim • Updated Jan. 16, 2019

FDA grants breakthrough designation to wearable dialysis device

The portable, wearable peritoneal dialysis device by Singapore-based AWAK Technologies is intended for patients with end-stage renal disease as an alternative to long hours of connection to large dialysis machines.

By Susan Kelly • Jan. 14, 2019

Uncertainties abound with growing prospect of hard Brexit

The future for medtech companies in Europe was further complicated Tuesday with Britain's government firmly rejecting PM Theresa May's EU exit deal by a vote of 432 to 202, prompting debate of a no-confidence vote Wednesday.

By Meg Bryant • Updated Jan. 16, 2019

5 medtech trends to watch in 2019

FDA regulatory changes, diagnostics legislation, a sustained focus on cybersecurity, looming European Union regulations and China trade headwinds are likely to take center stage.

By David Lim • Jan. 11, 2019

FDA to beef up Sentinel postmarket electronic safety system

The agency announced a five-year plan to expand and strengthen the system by adding new data types, developing analytic methods and recruiting more collaborators to the network.

By Susan Kelly • Jan. 11, 2019

Empatica gets FDA clearance for epilepsy monitor in children

The device analyzes motion and physiological signals to detect when the wearer is having a seizure.

By Nick Paul Taylor • Jan. 11, 2019

FDA denies citizen petition calling for electroconvulsive therapy ban

The agency dismissed claims that the devices pose an unreasonable risk of injury.

By Nick Paul Taylor • Jan. 10, 2019

Intuitive ends bumper 2018 with 19% growth in da Vinci procedures

The robotic surgery leader brushed off competition concerns to deliver another quarter of forecast-topping growth.

By Nick Paul Taylor • Jan. 10, 2019

Grassley to zoom in on drug pricing, insurance mergers as Senate panel chair

The new Republican chairman of the Senate Finance Committee laid out his agenda for the year ahead.

By David Lim • Jan. 10, 2019

UK updates no-deal Brexit advice as vote on withdrawal agreement nears

Companies will need a designated individual based in the U.K. to register medical devices in the country.

By Nick Paul Taylor • Jan. 10, 2019

Medtronic recalls imaging software used in brain surgery

The systems are being recalled due to reports of inaccurate information displaying during biopsy procedures.

By Susan Kelly • Jan. 9, 2019

Medical records key to Apple health strategy: report

Establishing itself as the platform for consumers' personal health records will be central to the tech giant's app, services and wearables strategies, according to a new report from research firm CB Insights.

By Susan Kelly • Jan. 9, 2019

JPM19: FDA warns it won't be long before user fee funding runs dry

With no end in sight to the government shutdown, Commissioner Scott Gottlieb said medical device user fee programs have about two to three months of funding left.

By Jacob Bell • Jan. 9, 2019

Boston Scientific, Medtronic give glimpse into 2019 at JPM

Boston Scientific's stock ticked up after its J.P. Morgan Healthcare Conference presentation Tuesday, whereas Medtronic's shares were down 6% Monday following conservative comments from company leadership.

By Maria Rachal • Jan. 9, 2019

Vocera debuts Smartbadge wearable with aim to improve clinical communications

The device will integrate with more than 140 clinical and operational systems, including EHRs, nurse call systems and physiologic monitors, the company said.

By Meg Bryant • Jan. 8, 2019

Hologic boosts its first-quarter revenue outlook

The device and diagnostics company, which specializes in women's healthcare, attributed the upturn to acceleration in its U.S. breast health, molecular diagnostics and international businesses.

By Susan Kelly • Jan. 8, 2019