Midterms 2018: Key health ballot votes in the states

It's not just Congress up for grabs in Tuesday's midterm elections. From Medicaid expansion to dialysis treatments to nurse staffing ratios, here's a snapshot of key votes, the odds and what they could mean for the industry.

By David Lim , Tony Abraham , Rebecca Pifer , Samantha Liss • Nov. 2, 2018

FDA deficient on device cybersecurity readiness, watchdog says

The inspector general called the agency's postmarketing efforts to police cyber threats to medical devices insufficient. The FDA said the report paints "an incomplete and inadequate" picture of the agency's oversight.

By Susan Kelly • Nov. 2, 2018

Explore the Trendline➔

Top 5 stories from MedTech Dive

From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.

By MedTech Dive staff

CMS finalizes DME bidding program overhaul despite cost

Administrator Seema Verma said the final rule will increase patient access to medical products, but an August GAO report found beneficiaries are able to get needed items under the current paradigm.

By David Lim • Nov. 2, 2018

Patient deaths following Getinge device shutdowns prompt FDA warning

The agency has reports of three patient deaths following intra-aortic balloon pump malfunctions.

By Nick Paul Taylor • Nov. 2, 2018

Zimmer gets FDA nod for knee implant as portfolio strategy advances

Clearance coincided with first use of the device maker's knee surgery robot. The CEO has been vague about how it will differentiate its knee and spine devices from rival products, such as those sold by Mazor Robotics and Stryker.

By Nick Paul Taylor • Nov. 1, 2018

Moody's boosts growth forecast for US medical device industry

The ramped up prediction comes in response to strong sales of relatively new, high-margin products at companies such as Edwards Lifesciences and Medtronic.

By Nick Paul Taylor • Nov. 1, 2018

NuVasive CEO says spine industry poised to consolidate

The spinal device maker said it is moving from belt-tightening to investment mode to take advantage of improving market conditions.

By Susan Kelly • Oct. 31, 2018

Baxter posts 'frankly disappointing' sales as hurricane aftereffects linger

"It is now becoming clear that the market dynamics have fundamentally shifted, at least in the near- to mid-term," Baxter CEO José Almeida said on the quarterly conference call with investors.

By Nick Paul Taylor • Oct. 31, 2018

Baxter earns CE mark for new renal replacement system

Launch of the PrisMax device builds on the company's Prismaflex technology for filtering the blood of critically ill patients, and is a key event for the company's acute therapies business.

By Susan Kelly • Oct. 30, 2018

Genentech releases more data on refillable eye implant

Study results showed that vision and anatomical outcomes in wet AMD patients who received the device, and dosed every six months or longer, were comparable to ranibizumab dosed every four weeks.

By Susan Kelly • Oct. 30, 2018

Leerink predicts Inspire to clear coverage blockade, quickly grow sleep apnea sales

The upbeat estimates assume another major insurer will cover the implant in the next 18 months.

By Nick Paul Taylor • Oct. 30, 2018

Look out device makers — Amazon set to sell glucose monitors, blood pressure cuffs

The products will be sold under the brand name Choice through a partnership with Arcadia Group, a consultancy firm with a history of partnering with big brand retailers like Walmart.

By Samantha Liss • Oct. 29, 2018

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

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