Medical Devices: Page 170
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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 -
Explore the Trendline➔
Sara Silbiger via Getty Images
TrendlineTop 5 stories from MedTech Dive
From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
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 -
OIG finds Pacific Medical received unallowable Medicare payments
The oversight body wants the provider of orthotic braces to refund almost $250,000.
By Nick Paul Taylor • Jan. 4, 2019 -
Deep Dive
What's in a connected medical device? Cybersecurity regulators want to know
FDA could require device makers to publicize a software bill of materials as early as the premarket application process to more quickly identify vulnerabilities in the event of a cyberattack.
By Meg Bryant • Jan. 3, 2019 -
Engineers tout advance in closed-loop neuromodulation system
The device is ready for testing in large animals and potentially humans as a treatment for certain brain disorders.
By Nick Paul Taylor • Jan. 3, 2019 -
HHS issues voluntary guidelines amid rise of cyberattacks
The department, together with an industry-led task force, compiled best practices on how to protect patients and health systems from growing cyberthreats.
By Samantha Liss • Jan. 2, 2019 -
Jacob Bell/MedTech Dive
Edwards gets FDA nod for Sapien 3 Ultra TAVR device
The agency Friday approved an expanded indication for the company's Sapien 3 transcatheter aortic valve replacement systems for patients with low surgical risk, the first product in the U.S. authorized for that population.
By Nick Paul Taylor • Updated Aug. 16, 2019 -
GAO: DME supplier pool shrinks under competitive bidding
The program designed to save Medicare money on durable medical equipment found the number of suppliers providing items at adjusted rates in certain areas fell 11% in 2017.
By Susan Kelly • Dec. 26, 2018 -
FDA reclassifies some electroconvulsive devices in final order
The agency has given manufacturers of devices not covered by the reclassification 90 days to file PMAs.
By Nick Paul Taylor • Dec. 23, 2018 -
Brian Tucker/MedTech Dive
Regulatory makeovers and international game changers: MedTech Dive's top stories of 2018
Hard looks at cybersecurity and digital health's hot streak also left their mark on the year.
By Maria Rachal • Dec. 22, 2018 -
Government shutdown partially shutters FDA
Hitting its 12th day, 7,053 employees, or more than 40% of the agency's workforce, is furloughed. Commissioner Scott Gottlieb said new guidance on ongoing activities will come later Wednesday.
By David Lim • Updated Jan. 2, 2019 -
3M completes acquisition of MModal's tech business for $1B
The manufacturer plans to use MModal's cloud-based, conversational AI technology in areas like population health, where 3M is already active.
By Meg Bryant • Updated Feb. 4, 2019
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