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

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

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

From robots to staplers, a top 10 list of medtech safety hazards

The nonprofit ECRI identified increased use of certain devices outside of acute care settings and adoption of some technologies before safety is fully assessed as common themes in its annual ranking.

By Susan Kelly • Oct. 8, 2019

Livongo scores biggest diabetes contract yet

Investors reacted to the news of the BCBS federal employee program agreement by bumping up Livongo's shares more than 18%. 

By Nick Paul Taylor • Oct. 8, 2019

Supreme Court slaps down Zimmer's request for review of $248M damages award in Stryker patent case

Zimmer Biomet exhausted its last possibility for review in the nearly nine-year-old infringement case involving a Stryker device patent, which awarded one of the highest ever amounts of enhanced damages in a patent infringement case.

By Dana Elfin • Oct. 7, 2019

Abbott pulling ahead in glucose monitoring race: UBS doc survey

The medtech giant's FreeStyle Libre device is expected to benefit from a low-cost pricing strategy and widening insurance coverage, which some doctors believe could spur price reductions across the CGM market.

By Susan Kelly • Oct. 7, 2019

Mechanical thrombectomy market poised to double: analysts

Clinical data and changes to treatment protocols support wider patient access to the technology, which could benefit device makers including Stryker, Medtronic and Penumbra, analysts at Jefferies said in a research report.

By Susan Kelly • Oct. 7, 2019

Intersect ENT misses endpoint on chronic sinusitis DCB, sending shares down

The company is "disappointed" the steroid delivery device, which it hopes to submit for premarket approval to FDA, did not prove superior on frontal sinus patency at 30 days when randomized against an uncoated balloon.

By Maria Rachal • Oct. 7, 2019