Medical Devices
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FDA targets late 2019 for hearing aid proposed rule
The plan comes two weeks after Bose won clearance to sell the first self-fitting hearing aid that can be programmed without the help of a healthcare provider.
By David Lim • Oct. 18, 2018
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Abbott medical device, diagnostic units drive Q3 growth
CEO Miles White said Abbott plans to submit its data to FDA in the coming weeks to back an expanded indication for MitraClip.
By David Lim • Oct. 17, 2018
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Medtronic sells workflow tool to boost its opioid pump
The system seeks to identify patients who might be good candidates for the device giant's drug delivery system.
By Susan Kelly • Oct. 17, 2018
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Zimmer Biomet and Apple see role for Watch app in hip, knee replacement recovery
The tech giant and Zimmer plan to enroll up to 10,000 U.S. patients to study a new app to coordinate care before and after joint replacement surgery.
By Meg Bryant • Oct. 16, 2018
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FDA boosts medical device cybersecurity coordination with Homeland Security
The DHS Office of Cybersecurity and Communications and FDA's device center will increase information sharing of potential and confirmed device vulnerabilities and threats.
By David Lim • Oct. 16, 2018
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J&J posts softer Q3 device sales
CFO Joseph Wolk told analysts he is not satisfied with the performance of the company's medical device business.
By Susan Kelly • Oct. 16, 2018
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Endologix recalls cardiac implants amid ongoing rupture risk
The Class I recall stems from reports of some devices failing to divert blood away from aneurysms.
By Nick Paul Taylor • Oct. 16, 2018
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FDA to fund pediatric medical device consortium
Led by Children's National Health System in Washington and the University of Maryland, College Park, the effort will connect individuals who have pediatric device ideas with potential manufacturers and other resources.
By Susan Kelly • Oct. 15, 2018
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TransEnterix wins FDA nod for smaller robotic instruments
The company is betting approval to launch an expanded set of smaller instruments will be a selling point to distinguish itself from Intuitive Surgical.
By Susan Kelly • Oct. 12, 2018
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FDA monitoring 11 device firms for shortages in aftermath of Hurricane Michael
In addition, HHS has moved 400 medical and public health professionals and medical equipment into impacted areas.
By David Lim • Oct. 12, 2018
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FDA warns of Medtronic device cybersecurity risk
The alert follows discovery that hackers could adjust the settings of cardiac devices. While the FDA has not received reports of patient harm, Medtronic has disabled the online software update.
By Nick Paul Taylor • Oct. 12, 2018
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Cardiology volumes seen boosting medtech companies in Q3
Leerink's survey of hospital administrators has implications for Boston Scientific, J&J and Medtronic as they begin to report results next week.
By Nick Paul Taylor • Oct. 12, 2018
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ICU Medical taps Imprivata for device cybersecurity support
The collaborators will work to protect network-connected infusion pumps.
By Nick Paul Taylor • Oct. 11, 2018
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TAVR volumes dip in Q3 amid 'aggressive surgeon pushback'
If a Leerink survey is right, analysts suggest the explosive growth experienced in high-risk patients will not be replicated in other populations, implying the devices will perform steadily rather than spectacularly.
By Nick Paul Taylor • Oct. 11, 2018
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Top Democrats question FDA Pre-Cert program safety, statutory authority
Concern that the agency may be overstepping its authority echoes comments submitted by the Clinical Decision Support Coalition.
By David Lim • Oct. 11, 2018
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RightEye's eye-tracking system gets FDA clearance
The company is carving a niche for its vision screening technology with applications in reading assessment and sports vision training, in addition to functional vision and brain issues.
By Susan Kelly • Oct. 10, 2018
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Siemens' latest 1.5T MRI scanner gets FDA nod
An increased focus on early disease diagnosis is helping drive rapid growth in the global MRI market.
By Susan Kelly • Oct. 10, 2018
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Stryker pens deals with Synaptive, Ziehm to boost navigation unit
The partnerships cover a 3D brain modeling program and intraoperative imaging device.
By Nick Paul Taylor • Oct. 10, 2018
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Researchers develop biodegradable nerve stimulation device
The hope of reducing risks with permanent implants drove stent makers such as Abbott to develop absorbable versions, but it halted sales after its version failed to catch on with interventional cardiologists.
By Susan Kelly • Oct. 09, 2018
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Eximo Medical gains FDA clearance for atherectomy laser
The device is the first 355 nm laser system cleared in the United States to treat peripheral artery disease and is designed to address unmet clinical needs for multiple vascular conditions.
By Susan Kelly • Oct. 09, 2018
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Deep DiveFDA takes aim at lack of pediatric devices
"Funding is a huge challenge because of the inherently small market," Reed McCarty, co-founder and partner at SandBox Medical, told MedTech Dive.
By Meg Bryant • Oct. 08, 2018
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1 in 5 health IT execs say malware has hit devices
Out-of-date operating systems and unavailability of patch solutions remain major cybersecurity risks for medical devices.
By Susan Kelly • Oct. 08, 2018
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Bose self-fitting hearing aid gets FDA approval
The product is the first to be cleared by the agency that can be purchased and programmed without a doctor's prescription.
By Susan Kelly • Oct. 08, 2018
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Remote patient monitoring cuts hospital admissions, ER visits, report finds
Heart disease and COPD are the most popular uses, but other less acute chronic conditions are starting to find traction with the technology, the industry and KLAS report found.
By Meg Bryant • Oct. 08, 2018
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Blackberry announces healthcare applications for Spark platform, blockchain ledger
The tech company also announced a secure, real-time software program to assist developers of connected medical devices.
By Meg Bryant • Oct. 05, 2018