Medical Devices: Page 138
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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 -
Explore the Trendline➔
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TrendlineMedical device safety in spotlight after high profile recalls
From Philips’ massive recall of respiratory devices to ongoing health risks with breast implants, medical devices tied to patient harm have put a focus on product safety.
By MedTech Dive staff -
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 -
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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 -
Q&A
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
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