FDA warns dental X-ray supplier over radiation exposure reporting

The agency said Denterprise International didn't report complaints involving patients accidentally exposed to radiation and asked for a retrospective review of all such incidents.

By Susan Kelly • Oct. 16, 2019

CMR launches robot, CEO says European deals coming soon

On the back of a $240 million private financing round, the U.K. medtech is beginning commercial expansion of its modular robotic surgery system in Europe and Asia as it awaits FDA's go-ahead.

By Maria Rachal • Oct. 16, 2019

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

ViewRay bucks payment fears in field dubbed 'not dead' yet

The radiation oncology company received eight new orders for its MRI-guided Linac, easily beating Jefferies' forecast. 

By Nick Paul Taylor • Oct. 16, 2019

Titan scraps filing plan for robotic surgical system amid cash crunch

The Canadian medtech is abandoning plans to seek FDA clearance to sell its single port system before 2021.

By Nick Paul Taylor • Oct. 16, 2019

J&J device business outperforms in China as US pricing pressures persist

Double-digit sales growth in China and a surge in contact lens purchases in Japan helped offset share declines in certain U.S. orthopaedics markets.

By Maria Rachal • Oct. 15, 2019

California bill to end excessive dialysis profits becomes law

Fresenius said it's concerned the new law will result in patients only being able to access care at hospitals due to lack of insurance coverage. 

By Susan Kelly • Oct. 15, 2019

Two weeks from Brexit deadline, UK floats device contingency

A no-deal Brexit would not meet any of MedTech Europe's four priorities. 

By Nick Paul Taylor • Oct. 15, 2019

Hospitals, manufacturers could donate cybersecurity software under proposed regs

With the cost of protecting systems from malicious hackers increasing, the idea to tweak the anti-kickback laws recognizes some physician practices don't have the resources or expertise to keep pace, one lawyer told MedTech Dive.

By David Lim • Oct. 14, 2019

Medical software makers get new guidance on MDR, IVDR

The European Commission's Medical Device Coordination Group aims to clarify which software will be subject to the new regulations, and how those products should be classified and placed on the market.

By Dana Elfin • Oct. 14, 2019

Abbott deepens Type 2 diabetes play with Omada partnership

While CGMs have been most widely adopted among the Type 1 population, Abbott has worked to show the technology's benefit in the under-penetrated Type 2 market, which accounts for 95% of all Americans living with diabetes.​

By Maria Rachal • Oct. 14, 2019

FDA pushes back against criticism of third party 510(k) review

The agency deflected suggestions that the plan puts the burden on patients and doctors to figure out which devices are safe.

By Susan Kelly • Oct. 14, 2019

GAO finds low uptake of disposable wound care devices

Advocates of the products, sold by companies including Acelity and Smith & Nephew, argue the size and cost make them preferable to durable devices when treating small wounds. 

By Nick Paul Taylor • Oct. 11, 2019

CDS software, labels for staplers and breast implants among FDA 2020 guidance priorities

The annual publication comes days after the White House issued an executive order aimed at limiting agency use of the documents.

By David Lim • Oct. 11, 2019

HHS hesitant to include implantable medical devices in Anti-Kickback safe harbor

The government appears to be considering various methods to exclude device manufacturers from its care coordination safe harbor while allowing digital health technologies used to remotely monitor patients to take advantage of it.

By David Lim • Oct. 10, 2019

Edwards-backed Corvia gets leg up with FDA breakthrough nod

The interatrial shunt device for heart failure patients with preserved or mid-range ejection fraction won benefits under the streamlined review. Edwards Lifesciences owns the exclusive right to acquire the company.

By Maria Rachal • Oct. 10, 2019

Tariff headwinds still hurting Philips' connected care margins, execs warn

CEO Frans van Houten told investors Thursday "increasing headwinds from tariffs and a delay in the impact of the mitigating actions" were among the factors denting third quarter margins, sending shares down about 9%.

By Maria Rachal • Oct. 10, 2019

Dekra Germany is first notified body designated under IVDR

The designation of the first notified body to review in vitro diagnostics means manufacturers can start working toward certification by the May 2022 deadline.

By Dana Elfin • Oct. 10, 2019

FDA makes final recommendations on vascular device labels

The guidance documents address issues such as the risk of coatings separating from devices.

By Nick Paul Taylor • Oct. 10, 2019

HHS pitches sweeping revamp of Anti-Kickback Statute, Stark Law

Several new safe harbors are proposed to encourage value-based care, allow patient engagement through furnishing of tools and supports, and permit certain remuneration in some CMS-sponsored models.

By David Lim • Oct. 9, 2019

Medtronic recalls more than 100K guide catheters for fragment risk

FDA cautioned the device's outer material could separate, leaving fractured pieces in the patient's bloodstream. There have been no deaths or serious injuries linked to the problem, but five complaints were reported.

By Susan Kelly • Oct. 9, 2019

Teleflex recalls GaleMed infant breathing device it distributed

The recall of respiratory products from a third-party manufacturer comes as the company is grappling with a separate recall of endotracheal tubes.

By Susan Kelly • Oct. 9, 2019

Move over gene therapy. Bioelectronics an 'underappreciated' multibillion-dollar market: McKinsey

GlaxoSmithKline and Google-backed Verily put the concept of using miniaturized electronic devices to treat disease in the spotlight in 2016.

By Nick Paul Taylor • Oct. 9, 2019

One Drop makes Walmart debut

Building on partnerships with Apple and Bayer, the digital health company has succeeded in getting its product in front of consumers despite competition in the diabetes management space.

By Nick Paul Taylor • Oct. 9, 2019

Medtronic stent graft system wins breakthrough designation

The device for minimally invasive repair of thoracoabdominal aortic aneurysm is currently being assessed in physician-sponsored IDE trials.

By Maria Rachal • Oct. 8, 2019

Medtech investor duo seeks to 'fill the gap' in device sector private funding

As big medtechs turn toward smaller players to fuel their pipelines, Justin Klein and Kirk Nielsen, managing partners of newly formed Vensana Capital, are looking to build out a $225 million portfolio in "a really undercapitalized sector."

By Maria Rachal • Oct. 8, 2019