Medical Devices: Page 163
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Uncertainties abound with growing prospect of hard Brexit
The future for medtech companies in Europe was further complicated Tuesday with Britain's government firmly rejecting PM Theresa May's EU exit deal by a vote of 432 to 202, prompting debate of a no-confidence vote Wednesday.
By Meg Bryant • Updated Jan. 16, 2019 -
5 medtech trends to watch in 2019
FDA regulatory changes, diagnostics legislation, a sustained focus on cybersecurity, looming European Union regulations and China trade headwinds are likely to take center stage.
By David Lim • Jan. 11, 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 -
FDA to beef up Sentinel postmarket electronic safety system
The agency announced a five-year plan to expand and strengthen the system by adding new data types, developing analytic methods and recruiting more collaborators to the network.
By Susan Kelly • Jan. 11, 2019 -
Empatica gets FDA clearance for epilepsy monitor in children
The device analyzes motion and physiological signals to detect when the wearer is having a seizure.
By Nick Paul Taylor • Jan. 11, 2019 -
Intuitive ends bumper 2018 with 19% growth in da Vinci procedures
The robotic surgery leader brushed off competition concerns to deliver another quarter of forecast-topping growth.
By Nick Paul Taylor • Jan. 10, 2019 -
FDA denies citizen petition calling for electroconvulsive therapy ban
The agency dismissed claims that the devices pose an unreasonable risk of injury.
By Nick Paul Taylor • Jan. 10, 2019 -
Grassley to zoom in on drug pricing, insurance mergers as Senate panel chair
The new Republican chairman of the Senate Finance Committee laid out his agenda for the year ahead.
By David Lim • Jan. 10, 2019 -
UK updates no-deal Brexit advice as vote on withdrawal agreement nears
Companies will need a designated individual based in the U.K. to register medical devices in the country.
By Nick Paul Taylor • Jan. 10, 2019 -
Medical records key to Apple health strategy: report
Establishing itself as the platform for consumers' personal health records will be central to the tech giant's app, services and wearables strategies, according to a new report from research firm CB Insights.
By Susan Kelly • Jan. 9, 2019 -
Medtronic recalls imaging software used in brain surgery
The systems are being recalled due to reports of inaccurate information displaying during biopsy procedures.
By Susan Kelly • Jan. 9, 2019 -
JPM19: FDA warns it won't be long before user fee funding runs dry
With no end in sight to the government shutdown, Commissioner Scott Gottlieb said medical device user fee programs have about two to three months of funding left.
By Jacob Bell • Jan. 9, 2019 -
Boston Scientific, Medtronic give glimpse into 2019 at JPM
Boston Scientific's stock ticked up after its J.P. Morgan Healthcare Conference presentation Tuesday, whereas Medtronic's shares were down 6% Monday following conservative comments from company leadership.
By Maria Rachal • Jan. 9, 2019 -
Vocera debuts Smartbadge wearable with aim to improve clinical communications
The device will integrate with more than 140 clinical and operational systems, including EHRs, nurse call systems and physiologic monitors, the company said.
By Meg Bryant • Jan. 8, 2019 -
Hologic boosts its first-quarter revenue outlook
The device and diagnostics company, which specializes in women's healthcare, attributed the upturn to acceleration in its U.S. breast health, molecular diagnostics and international businesses.
By Susan Kelly • Jan. 8, 2019 -
TransEnterix forecasts revenue growth, sells more robots
The sole competitor to Intuitive Surgical said it sold 15 of its units in 2018 and expects to report annual revenue of $24 million, an increase of 238% from the year before.
By Susan Kelly • Jan. 8, 2019 -
Boston Scientific reports $9.82B in 2018 sales
The company released initial data showing 6.3% sales growth during the fourth quarter ahead of its presentation at the J.P. Morgan investment conference.
By Maria Rachal • Jan. 8, 2019 -
Health Affairs study calls for Medicare coverage of hearing care services
Research found that lower-income people with a hearing aid are twice as likely to experience trouble hearing compared to those with a higher income.
By David Lim • Jan. 8, 2019 -
FDA targets De Novo path to shepherd medical software through Pre-Cert
One industry lawyer questioned if the agency's most recent iteration will limit the program's potential by relying on the De Novo pathway, historically used rarely compared to its 510(k) program.
By David Lim • Jan. 8, 2019 -
CMS issues new DME strategy for patients dually-eligible for Medicare, Medicaid
The change is intended to eliminate a barrier to accessing durable medical equipment.
By Nick Paul Taylor • Jan. 8, 2019 -
Endologix recalls Nellix aneurysm sealing system
The company said off-label use of the device was causing "suboptimal" patient outcomes, though the system worked well when current clinical indications were followed.
By Susan Kelly • Jan. 7, 2019 -
Hospitals gain leverage on medical device pricing: report
Price transparency in the sector is at an all-time high, thanks to consolidation among the industry's hospital customers and an increasingly connected environment, according to Charles River Associates.
By Susan Kelly • Jan. 7, 2019 -
Wright Medical posts $9.5M in Cartiva revenue, beating expectations
The device maker's acquisition of Cartiva and its big toe arthritis implant boosted results.
By David Lim • Jan. 7, 2019 -
Cancer doc treatment choices may be skewed by financial incentives, study shows
Physicians in freestanding radiotherapy centers were more likely to self-refer radiation treatment for patients, according to the report in JAMA Oncology.
By Meg Bryant • Jan. 4, 2019 -
Booz Allen gives FDA device center progress high marks
Agency staff said better access to information about prior regulatory decisions of similar devices and more structured electronic submissions from manufacturers would help improve review efficiency.
By David Lim • Jan. 4, 2019 -
Analysts predict Medtronic will lose ground in booming insulin pump market
A Leerink survey suggests Insulet and Tandem Diabetes Care will claim a bigger slice of the expanding market.
By Nick Paul Taylor • Jan. 4, 2019
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