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

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

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

AngioDynamics buys Eximo to challenge Philips for PAD market, cutting EPS targets

AngioDynamics' acquisition of Eximo Medical for up to $66 million gives it an FDA-cleared laser treatment for peripheral artery disease.

By Nick Paul Taylor • Oct. 4, 2019

Survey finds CMS changes might slow radiation oncology purchases

One-third of physicians surveyed expect the bundled payment model to negatively affect purchasing, according to UBS analysts. Still, more than half expect to buy a new system within the next 12 months.

By Nick Paul Taylor • Oct. 4, 2019

Paclitaxel device makers roll out revised labels, fresh safety analyses

Philips and BD highlighted independent analyses published this week defending their drug-coated balloons as manufacturers update product labels acknowledging a late mortality signal in peripheral artery disease patients.

By Maria Rachal • Oct. 3, 2019

IMDRF cybersecurity guidance favors total product life cycle approach

The International Medical Device Regulators Forum's draft mirrors U.S. regulators' support for a total product life cycle strategy, but does not include a tiered approach to categorizing risk laid out by FDA last year.

By Nick Paul Taylor • Oct. 3, 2019

Some Class I devices could get 4 extra years to comply with EU MDR

The European Union's Medical Device Coordinating Group met with medical device stakeholders Monday in advance of an expected vote on a corrigendum to amend or modify some parts of major upcoming EU regulatory changes.

By Dana Elfin • Oct. 2, 2019

DME industry pans CMS' gap-fill proposal, but agrees current system is "fundamentally flawed"

CMS' proposed framework to compare new technology to older items is not sufficiently fleshed out and isn't transparent enough, the American Association for Homecare said.

By David Lim • Oct. 2, 2019

Third-party software vulnerability could endanger medical devices, FDA and DHS warn

The alerts expand the list of vendors whose operating systems could be exploited due to vulnerabilities known as URGENT/11. Medical devices affected include an infusion pump and an anesthesia machine, FDA said Tuesday.

By Susan Kelly • Oct. 2, 2019

Researchers automate EHR analysis for postmarket safety surveillance

Stanford researchers found an automated system extracted the vast majority of reports of complications and pain in electronic health records for hip replacement patients.

By Nick Paul Taylor • Oct. 2, 2019

Stryker inks Conformis deal to develop custom knee surgery instruments

The deal could give Stryker technology to rival devices used by Johnson & Johnson, Smith & Nephew and Zimmer Biomet.

By Nick Paul Taylor • Oct. 2, 2019

Robotics, navigation systems create buzz at spine meeting

Medtronic, NuVasive and Globus Medical showed off robotic applications at the North American Spine Society gathering in Chicago. "[A]doption of more advanced platforms is not an if, but a when," Jefferies analysts wrote.

By Susan Kelly • Oct. 1, 2019

Sterigenics abandons effort to reopen Willowbrook ethylene oxide sterilization facilities

The company behind the major medical device sterilization plant said it is "actively taking steps to ensure customer and patient needs continue to be met by our other facilities."

By David Lim • Sept. 30, 2019