Medical Devices

FDA flags mortality risk of paclitaxel with stents, balloons for PAD

The letter to physicians follows a study identifying increased risk of death for patients two years after treatment for peripheral artery disease with a drug-coated balloon or drug-eluting stent.

By Susan Kelly • Jan. 18, 2019
LivaNova highlights studies into efficacy, value of sutureless aortic valve

The research suggests the valve, Perceval, may have advantages over competing technologies.

By Nick Paul Taylor • Jan. 18, 2019
BD, Mercy ally to use clinical data to boost device use

The agreement follows similar deals between the health system and J&J and Medtronic. BD also on Thursday morning reaffirmed its 2019 revenue growth guidance of 8.5% to 9.5%.

By Nick Paul Taylor • Jan. 17, 2019
Abbott inks Cephea buyout to boost mitral valve pipeline

The takeover gives Abbott another valve replacement device to rival those owned by Edwards and Medtronic.

By Nick Paul Taylor • Jan. 17, 2019
Mayo, Arizona State team up to found medtech startup accelerator

The six-month program is designed to connect startups with investors and physicians.

By Nick Paul Taylor • Jan. 17, 2019
Top House Democrat to focus on diagnostics revamp, drug prices in 2019

With Democrats now in power, the new chair of a key oversight subcommittee laid out her priorities, including proposals she argues will bolster the Affordable Care Act.

By David Lim • Jan. 17, 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
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
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
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
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 at 11:04 a.m.
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
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
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
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
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 at 8:48 a.m.
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 at 10 a.m.
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
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
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
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