The Latest
-
3M completes $6.7B takeout of Acelity
The deal adds new advanced wound care and specialty surgical application offerings to the Minnesota conglomerate's medical business.
UPDATED: Oct. 11, 2019 at 5:01 p.m. -
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.
-
Amazon Textract now HIPAA-eligible as tech giant expands AI portfolio
Of Amazon's $3.1 billion in operating income last quarter, more than half came from its cloud services business.
-
FDA clears first rapid Ebola virus diagnostic
Risk of flare up remains, but the United Nations called the outbreak responsible for killing 2,100 people over 14 months in the Democratic Republic of the Congo "significantly contained."
-
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.
-
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.
-
Fresenius to pay $5.2M to settle Medicare overbilling allegations
DOJ alleged the company overbilled Medicare for more than seven years by ordering hepatitis B tests for patients it knew to be immune to the virus.
-
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.
-
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."
-
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%.
-
FDA makes final recommendations on vascular device labels
The guidance documents address issues such as the risk of coatings separating from devices.
-
Experimental cancer IVD trial guidance finalized
AdvaMed won many many of the changes it sought during the comment period, including ones related to communication with the FDA.
-
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.
-
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.
-
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.
-
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.
-
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.
-
Qiagen taps new CEO, restructures in 'clearly a bad day'
The company is also suspending next-generation sequencing-related instrument development as it pivots into a 15-year partnership with Illumina to develop in vitro diagnostic kits.
-
SponsoredStreamlining your portfolio can actually improve profitability. Here's how.
Retiring products is not an easy decision, but taking this step can have a real and positive impact on the P&L, customer, cross-functional teams and the ability to drive innovation.
-
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.
-
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.
-
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.
-
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%.
-
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.
-
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.
