The Latest
-
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.
Medical Devices -
Boston Scientific closes Augmenix acquisition for $600M
The device giant expects sales of the SpaceOar Hydrogel System to be $50 million in 2018 and $90 million in 2019.
M&A -
FDA clears Pfizer PARP drug, Myriad companion test for breast cancer
Patients must be selected for treatment based on Myriad's test to identify those eligible for talazoparib.
Diagnostics -
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.
Medical Devices -
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.
Medical Devices -
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.
Medical Devices -
Anthem shells out $16M to settle biggest health data breach in history
The fund will pay for four years of credit monitoring and all other claims, costs and fees for affected individuals, according to the settlement.
Policy & Regulation -
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.
Medical Devices -
MIT plans $1B computing college, AI research effort
The new college will explore and promote AI's use in non-technology disciplines with a focus on ethical considerations, which are a growing concern as the technology becomes embedded in many fields.
Research -
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.
Medical Devices -
Blue Button 2.0 doubles developers to 1,200, but beneficiary uptake tiny
CMS Administrator Seema Verma tells MedTech Dive that 11 organizations have "production apps" in place using live data.
Policy & Regulation -
Health apps require robust regulatory approach: JAMA opinion
The current FDA framework to revamp software regs in the Pre-Cert program is too short on checks to safety and whether products improve outcomes, the authors said. The concerns echo those made by Senate Democrats.
Digital Health -
National Academy of Medicine argues barriers to interoperability are organizational, not technical
An extensive report outlining challenges and recommendation for data sharing comes as the industry awaits a rule from HHS that attempts to thwart information blocking.
Policy & Regulation -
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.
Medical Devices -
Amazon, Walmart patents highlight potential of biometric monitoring
The developments come as both companies ramp up their involvement in healthcare.
Research -
CT scans can diagnose complex heart disease, study shows
The GE-funded trial found that a heart team's treatment recommendations based on a CT scan from a GE system were similar to those of a separate team making its decision based on conventional angiography.
Imaging -
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.
Medical Devices -
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.
Medical Devices -
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.
Medical Devices -
FDA OKs DNA-based test for blood transfusion compatibility
Grifols unit Progenika Biopharma's product is the second molecular assay approved for use in transfusion medicine and the first approved to report genotypes as final results.
Diagnostics -
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.
Medical Devices -
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.
Medical Devices -
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.
Medical Devices -
Walgreens, LabCorp team to add 600 more blood draw clinics
The new specimen collection facilities mark a major expansion of the partnership, the latest in a wave of vertical integration.
M&A -
Suki AI-based voice assistant tops 1K patient encounters a week
The health IT startup claims it can sharply drop the time spent on medical notes.
Digital Health