Medical Devices: Page 157
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FDA qualifies test for traumatic brain injury
The OsiriX CDE test can now be used by medical device developers to identify and enroll patients in studies of TBI, which has been researched for years but has no effective treatment.
By Susan Kelly • March 13, 2019 -
Smith & Nephew buys skin substitute maker for $660M
The company announced Wednesday it closed the acquisition of Osiris Therapeutics.
By Susan Kelly • Updated April 17, 2019 -
Explore the Trendlineâž”
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TrendlineMedical 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 -
Hill-Rom strikes $180M Voalte takeover to boost connected care unit
The acquisition will give the hospital equipment maker a communications system to complement its portfolio of smart devices.
By Nick Paul Taylor • March 13, 2019 -
Omada adds connected blood pressure cuff, glucometer to health program
The devices will enable participants in the digital health platform's disease prevention and management program to collect and share data.
By Nick Paul Taylor • March 13, 2019 -
Diagnostic errors compounded by EHRs No. 1 safety fear: ECRI
"We have to recognize the limits of current technology and ensure that we have processes in place to close the loop on diagnostic tests," the medical device watchdog's William Marcella said.
By Meg Bryant • March 12, 2019 -
NCI Director Ned Sharpless to be named FDA acting commissioner
Sharpless will succeed FDA Commissioner Scott Gottlieb in early April. He has served as director of the National Cancer Institute since October 2017.
By David Lim , Maria Rachal • Updated March 12, 2019 -
Intrathecal drug delivery system wins FDA breakthrough designation
The accelerated review status follows Alcyone's announcement of a strategic collaboration with Roche to develop treatment options for patients with neurological disorders.
By Susan Kelly • March 12, 2019 -
Edwards deepens structural heart position with new investments
Deals with Corvia Medical and Mitralign could bolster the valve specialist's structural heart treatment abilities, where the company said it intends to remain focused.
By Susan Kelly • March 12, 2019 -
FDA digital health efforts highlighted in Trump budget
The blueprint calls for Medicare coverage for breakthrough devices.
By David Lim • March 12, 2019 -
UK to probe safety of paclitaxel cardiovascular devices
The investigation will review data linking drug-coated balloon catheters and drug-eluting stents to increased death rates, including studies of those sold by Boston Scientific, Cook Medical, C.R. Bard, Medtronic and others.
By Nick Paul Taylor • March 12, 2019 -
FDA flags surgical stapler risks, plans advisory meeting
The agency alerted healthcare providers to an increasing number of medical device reports associated with use of surgical staplers, including at least 366 deaths and more than 9,000 serious injuries.
By Susan Kelly • March 11, 2019 -
TAVR for low-risk patients in spotlight at ACC
Jefferies analysts predict results from valve makers Edwards Lifesciences and Medtronic will "usher in the low risk era for TAVR," expanding the market for the devices.
By Susan Kelly • March 11, 2019 -
AdvaMed raises concerns with FDA's proposed De Novo model
In comments on FDA's proposed De Novo classification rule, the medical device lobby said it is concerned the framework would impose some requirements that replicate the premarket approval application review.
By Susan Kelly • March 11, 2019 -
CMS updates 2021 DME bidding round plans, adds new product categories
The American Association for Homecare argued addition of non-invasive ventilators to the competitive bidding program will drive companies out of business.
By David Lim • March 11, 2019 -
In bid for new users, Fitbit expands Solera partnership
Fitbit Health Solutions COO Amy McDonough told MedTech Dive many users enrolled in a diabetes prevention program through the partnership choose to later buy a more expensive Fitbit.
By David Lim • March 8, 2019 -
Bard pulls mesh implants from EU
Despite thousands of adverse event reports globally, the BD subsidiary cited the burden of generating clinical data required by new EU rules as the reason for ceasing distribution and sales.
By Nick Paul Taylor • March 8, 2019 -
Tandem suspends software use in pivotal closed loop study to fix bug
The company sought to quell nerves, but investors pushed the stock down 8% on safety concerns.
By Nick Paul Taylor • March 7, 2019 -
Medicare panel gives equivocal backing to Novocure's brain cancer device
The panelists expressed some confidence that the Optune device improves outcomes but also raised concerns related to issues like patient compliance.
By Nick Paul Taylor • March 7, 2019 -
Pharma strikes $220M deal for pain device player Myoscience
New Jersey-based Pacira is moving into the device sector to build a portfolio of pain products capable of reducing the need for opioids.
By Nick Paul Taylor • March 6, 2019 -
FDA proposes exempting some flow cytometers from 510(k) requirements
The change is intended to streamline the path to market for some devices that count or characterize cells.
By Nick Paul Taylor • March 6, 2019 -
Device to detect internal bleeding wins De Novo clearance
The monitoring system targets patients who could experience complications during percutaneous procedures using large diameter catheters such as TAVR.
By Susan Kelly • March 5, 2019 -
Masimo brain monitor gets CE mark pediatric indication
The device is now available for use in patients between ages 1 and 18 who undergo anesthesia for surgical or diagnostic procedures.
By Susan Kelly • March 5, 2019 -
US kidney care getting revamp, HHS officials say
HHS Secretary Alex Azar pushed for the development of wearable and implantable artificial kidneys.
By Rebecca Pifer • March 4, 2019 -
Deep Dive
Mixing medicine and money: Why the rise of health system VCs is raising ethical concerns
More dollars than ever are flowing from VCs affiliated with nonprofit health systems, spurring questions around conflicts of interest.
By Taylor McKnight • March 4, 2019 -
CVS to close retail audiology centers ahead of over-the-counter regulations
FDA has made clear it believes consumers should be able to take a more active role in managing hearing loss.
By David Lim • March 4, 2019
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