5 sticking points in the EU medical device reg transition

Brexit and notified body capacity are among the uncertainties, as many in the medtech sector are uninformed.

By Meg Bryant • Oct. 29, 2018

FDA panel to review first-of-a-kind heart failure device

The advisory group will vote on Impulse Dynamics' premarket application for a cardiac contractility modulation device to treat class III heart failure at a December meeting.

By Susan Kelly • Oct. 29, 2018

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

Drug-delivery device developer snags Sanofi as investor

Cincinnati, Ohio-based Enable Injections is developing a wearable device for subcutaneous delivery of biologics and other therapeutics.

By Susan Kelly • Oct. 29, 2018

Cleveland Clinic pegs 10 potentially game-changing medical innovations

Alternative pain therapies to fight the opioid epidemic topped the list. Others include AI, new guidelines for an expanded stroke treatment window, advances in immunotherapy for cancer and 3D printed, patient-specific products.

By Meg Bryant • Oct. 26, 2018

Stryker touts benefits of Mako robot on knee outcomes, costs

The medical device maker said robot-assisted procedures are gaining traction in orthopaedic surgery, contributing to an 8% growth rate in sales of the company’s knee replacements in the third quarter.

By Susan Kelly • Oct. 26, 2018

Zimmer profit rises 64% in Q3, driven by knee, hip products

Although implant sales were clear profit growth drivers, Zimmer saw small but marked increases across each of its portfolios.

By Rebecca Pifer • Oct. 26, 2018

ResMed posts double-digit growth as software sales soar

Results were burnished by the acquisition of home health software provider HEALTHCAREfirst.

By Nick Paul Taylor • Oct. 26, 2018

Novarad augmented reality system for surgery clears FDA

The OpenSight system is designed for use with Microsoft HoloLens technology.

By Meg Bryant • Oct. 25, 2018

Medtronic's dose-controlling app for pain pump gets FDA nod

The technology enables users to deliver doses on demand to cope with breakthrough pain.

By Nick Paul Taylor • Oct. 25, 2018

Adverse events prompt FDA to advise monitoring of Alcon implants

For now, the FDA says the problem looks to be limited to Alcon's implant. Glaukos markets a rival iStent device and saw its stock price increase by 40% when Alcon withdrew its stent.

By Nick Paul Taylor • Oct. 25, 2018

Boston Scientific posts strong Q3 with 8.7% sales growth

Coming off a legal win in a patent battle with Edwards, the CEO held his cards close to the vest on next steps on the earnings call.  

By David Lim • Updated Oct. 25, 2018

Edwards Lifesciences Q3 sales up 10%

Sales of transcatheter aortic valves implanted without open heart surgery rose 16% to $558 million, even as the company's market share outside the U.S. declined slightly and royalty revenue fell.

By Susan Kelly • Oct. 24, 2018

LabCorp blames data breach, hurricane for substandard Q3

The diagnostics branch was "particularly disappointing," said chairman and CEO Dave King.

By Rebecca Pifer • Oct. 24, 2018

Medtronic's low-profile thoracic endograft gets FDA nod

By expanding TEVAR to patients with a broader range of anatomies, Medtronic could gain an edge over rivals Bolton Medical, Cook Medical and Gore Medical.

By Nick Paul Taylor • Oct. 24, 2018

Stryker closes Invuity acquisition

Invuity's CEO called out "a lack of strategic organizational alignment in our sales and marketing efforts" during its Q2 earnings call, something that Stryker may be well positioned to help fix. 

By David Lim • Oct. 23, 2018

Heater-cooler device redesigned to limit infections: FDA

The LivaNova system used to warm and cool patients during open heart surgery has been the subject of a recall and a number of federal safety communications related to nontuberculous mycobacteria infections.

By Susan Kelly • Oct. 22, 2018

Abbott HeartMate 3 gets OK as transplant alternative

The Momentum 3 results could help Abbott gain market share from competitor Medtronic's ventricular assist device called HeartWare, acquired in 2016, according to analysts.

By Susan Kelly • Oct. 22, 2018

Stryker asks to extend anti-trust deadline for K2M deal

The ask comes as the companies face two shareholder lawsuits challenging the merger on the grounds that K2M failed to disclose financial projections needed to fairly assess the transaction.

By Susan Kelly • Oct. 22, 2018

Cardinal credit downgraded after debt-fueled medtech expansion

Fitch said $9 billion in debt is subject to risks, such as failing to realize the expected synergies from integrating assets bought from Medtronic.

By Nick Paul Taylor • Oct. 19, 2018

Viseon gets 510(k) clearance for spinal surgery device

The product enables visualization of surgical sites during minimally-invasive procedures.

By Nick Paul Taylor • Oct. 19, 2018

Intuitive Surgical sees 20% growth in da Vinci robot use

Several big medtechs are nipping at the heels of Intuitive with plans to introduce robotic surgery systems in the next few years, but so far, its dominance is unchallenged.

By Susan Kelly • Oct. 19, 2018

FDA sets busy year-end medical device to-do list

Improving mammography quality, revamping the De Novo classification process and revising the definition of a medical device to exclude certain medical software are some of the agency's priorities.

By David Lim • Oct. 19, 2018

FDA targets late 2019 for hearing aid proposed rule

The plan comes two weeks after Bose won clearance to sell the first self-fitting hearing aid that can be programmed without the help of a healthcare provider.

By David Lim • Oct. 18, 2018

Abbott medical device, diagnostic units drive Q3 growth

CEO Miles White said Abbott plans to submit its data to FDA in the coming weeks to back an expanded indication for MitraClip.

By David Lim • Oct. 17, 2018

Medtronic sells workflow tool to boost its opioid pump

The system seeks to identify patients who might be good candidates for the device giant's drug delivery system.

By Susan Kelly • Oct. 17, 2018