Medical Devices: Page 167
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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 -
Explore the Trendlineâž”
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TrendlineMedical device safety in spotlight after high profile recalls
From Philips’ massive recall of respiratory devices to ongoing health risks with breast implants, medical devices tied to patient harm have put a focus on product safety.
By MedTech Dive staff -
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 -
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 -
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 -
FDA-cleared, wearable blood pressure device hits market
A cuff in the wrist watch band inflates to capture systolic and diastolic pressure.
By Maria Rachal • Dec. 21, 2018 -
Bayer, FDA lengthen Essure postmarketing study to 5 years
The German pharma announced in July it would no longer sell the birth control implant in the U.S. due to falling sales.
By David Lim • Dec. 21, 2018 -
Health Canada unveils plan to improve medical device safety
The action plan follows an extensive journalistic investigation which uncovered deficient testing of medical devices and underreporting of injuries and deaths resulting from implants.
By Susan Kelly • Dec. 21, 2018 -
Allergan loses CE mark for textured breast implants, opening EU market
FDA plans to hold a meeting on breast implant safety in 2019 as it "monitors the known risks associated with breast implants, such as capsular contracture, implant rupture and breast implant-associated anaplastic large cell lymphoma."
By David Lim • Dec. 20, 2018 -
FDA pitches shorter grace period for UDI revision
The agency wants information submitted to the UDI database to be available to public users within one week, cutting back the 30 days companies have been given to edit their submissions for the last four years.
By Maria Rachal • Dec. 20, 2018 -
UK regulator puts brakes on Thermo Fisher-Gatan deal
The Competition and Markets Authority said Thermo Fisher’s proposed $925 million acquisition of Roper Technologies' Gatan business could raise prices or lower quality for customers using specialized microscopes.
By Susan Kelly • Dec. 20, 2018 -
Medtronic launches spinal surgery system with Mazor technology
U.S. patients are now being treated with Medtronic's fully-integrated spinal surgery system, born from the 2018 buyout of Israel's Mazor Robotics.
By Maria Rachal • Updated Jan. 28, 2019
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