Medical Devices
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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. 09, 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. 09, 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. 09, 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. 09, 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. 09, 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. 08, 2019 -
Q&AMedtech 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. 08, 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. 08, 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. 08, 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. 07, 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. 07, 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. 07, 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. 07, 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. 04, 2019
