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

Explore the Trendline➔

Medical device industry continues to turn to AI

While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.

By MedTech Dive staff

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

Zimmer Biomet and Apple see role for Watch app in hip, knee replacement recovery

The tech giant and Zimmer plan to enroll up to 10,000 U.S. patients to study a new app to coordinate care before and after joint replacement surgery.

By Meg Bryant • Oct. 16, 2018

FDA boosts medical device cybersecurity coordination with Homeland Security

The DHS Office of Cybersecurity and Communications and FDA's device center will increase information sharing of potential and confirmed device vulnerabilities and threats.

By David Lim • Oct. 16, 2018

J&J posts softer Q3 device sales

CFO Joseph Wolk told analysts he is not satisfied with the performance of the company's medical device business.

By Susan Kelly • Oct. 16, 2018

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

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

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

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

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