Endologix recalls cardiac implants amid ongoing rupture risk

The Class I recall stems from reports of some devices failing to divert blood away from aneurysms.

By Nick Paul Taylor • Oct. 16, 2018

FDA to fund pediatric medical device consortium

Led by Children's National Health System in Washington and the University of Maryland, College Park, the effort will connect individuals who have pediatric device ideas with potential manufacturers and other resources.

By Susan Kelly • Oct. 15, 2018

Explore the Trendline➔

Top 5 stories from MedTech Dive

From the effects of layoffs at the Food and Drug Administration and President Donald Trump’s tariff policies to the top medtech trends of 2026, here is a collection of top stories from MedTech Dive.

By MedTech Dive staff

TransEnterix wins FDA nod for smaller robotic instruments

The company is betting approval to launch an expanded set of smaller instruments will be a selling point to distinguish itself from Intuitive Surgical.

By Susan Kelly • Oct. 12, 2018

FDA monitoring 11 device firms for shortages in aftermath of Hurricane Michael

In addition, HHS has moved 400 medical and public health professionals and medical equipment into impacted areas.

By David Lim • Oct. 12, 2018

FDA warns of Medtronic device cybersecurity risk

The alert follows discovery that hackers could adjust the settings of cardiac devices. While the FDA has not received reports of patient harm, Medtronic has disabled the online software update.

By Nick Paul Taylor • Oct. 12, 2018

Cardiology volumes seen boosting medtech companies in Q3

Leerink's survey of hospital administrators has implications for Boston Scientific, J&J and Medtronic as they begin to report results next week.

By Nick Paul Taylor • Oct. 12, 2018

ICU Medical taps Imprivata for device cybersecurity support

The collaborators will work to protect network-connected infusion pumps.

By Nick Paul Taylor • Oct. 11, 2018

TAVR volumes dip in Q3 amid 'aggressive surgeon pushback'

If a Leerink survey is right, analysts suggest the explosive growth experienced in high-risk patients will not be replicated in other populations, implying the devices will perform steadily rather than spectacularly.​

By Nick Paul Taylor • Oct. 11, 2018

Top Democrats question FDA Pre-Cert program safety, statutory authority

Concern that the agency may be overstepping its authority echoes comments submitted by the Clinical Decision Support Coalition.

By David Lim • Oct. 11, 2018

RightEye's eye-tracking system gets FDA clearance

The company is carving a niche for its vision screening technology with applications in reading assessment and sports vision training, in addition to functional vision and brain issues.

By Susan Kelly • Oct. 10, 2018

Siemens' latest 1.5T MRI scanner gets FDA nod

An increased focus on early disease diagnosis is helping drive rapid growth in the global MRI market.

By Susan Kelly • Oct. 10, 2018

Stryker pens deals with Synaptive, Ziehm to boost navigation unit

The partnerships cover a 3D brain modeling program and intraoperative imaging device.

By Nick Paul Taylor • Oct. 10, 2018

Eximo Medical gains FDA clearance for atherectomy laser

The device is the first 355 nm laser system cleared in the United States to treat peripheral artery disease and is designed to address unmet clinical needs for multiple vascular conditions.

By Susan Kelly • Oct. 9, 2018

Researchers develop biodegradable nerve stimulation device

The hope of reducing risks with permanent implants drove stent makers such as Abbott to develop absorbable versions, but it halted sales after its version failed to catch on with interventional cardiologists.

By Susan Kelly • Oct. 9, 2018

FDA takes aim at lack of pediatric devices

"Funding is a huge challenge because of the inherently small market," Reed McCarty, co-founder and partner at SandBox Medical, told MedTech Dive.

By Meg Bryant • Oct. 8, 2018

1 in 5 health IT execs say malware has hit devices

Out-of-date operating systems and unavailability of patch solutions remain major cybersecurity risks for medical devices.

By Susan Kelly • Oct. 8, 2018

Bose self-fitting hearing aid gets FDA approval

The product is the first to be cleared by the agency that can be purchased and programmed without a doctor's prescription.

By Susan Kelly • Oct. 8, 2018

Remote patient monitoring cuts hospital admissions, ER visits, report finds

Heart disease and COPD are the most popular uses, but other less acute chronic conditions are starting to find traction with the technology, the industry and KLAS report found.

By Meg Bryant • Oct. 8, 2018

Blackberry announces healthcare applications for Spark platform, blockchain ledger

The tech company also announced a secure, real-time software program to assist developers of connected medical devices.

By Meg Bryant • Oct. 5, 2018

CMS tweaks local coverage policy to speed access to medical devices

AdvaMed CEO Scott Whitaker said that the CMS actions are commendable, but more should be done.

By David Lim • Oct. 4, 2018

European Parliament passes device-friendly changes to draft HTA law

The amendments will limit the types of devices that undergo joint clinical assessments.

By Nick Paul Taylor • Oct. 4, 2018

Regulatory professionals working in devices paid far less than pharma peers

Reg managers in the drug industry take home around 75% more than their device counterparts.

By Nick Paul Taylor • Oct. 4, 2018

Artificial pancreas has edge over insulin pump therapy in study

New research adds to evidence that a hybrid closed-loop insulin delivery system, also known as the artificial pancreas, offers better blood sugar control than sensor-augmented pump therapy in patients with type 1 diabetes.

By Susan Kelly • Oct. 3, 2018

Baxter, Mayo team up on outpatient kidney care center

The health system and device company will open a renal care center at Mayo's campus in Jacksonville, Florida, the first initiative to come out of a broader five-year agreement announced in 2017.

By Susan Kelly • Oct. 3, 2018

US pays 6 times more than Germany for cardiac implants, study finds

A dramatic divergence in the prices of stents and pacemakers was the most striking finding from an analysis of what hospitals in five countries pay.

By Nick Paul Taylor • Oct. 3, 2018