The Latest
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FDA sounds alarm about off-label drug use in pain pumps
The agency wants physicians to stick to approved drugs to reduce the risk of device failure in the pumps, which include those sold by Medtronic and J&J.
Medical Devices -
House chairman sees 'every indication' that VA's EHR difficulties will continue
"Frankly," Indiana Rep. Jim Banks said, "the more I learn about the EHR program, the more daunting it has become."
Policy & Regulation -
ResMed wraps up $750M MatrixCare buyout in SaaS push
The sleep apnea company has spent almost $1.7 billion on software businesses in recent years.
Medical Devices -
US Vascular gets FDA warning letter for long-running problems
Most of the points raised in the regulatory notice date back to a 2016 inspection.
Medical Devices -
FDA plans to waive informed consent for some clinical trials
The change would enable sponsors to run certain minimal-risk studies without gaining consent from participants.
Policy & Regulation -
Medtronic gets CE mark for low-profile thoracic endograft
The clearance comes weeks after FDA approved the Valiant Navion TEVAR endograft.
Medical Devices -
Atlantic gains FDA nod for wearable incontinence device
The device delivers electrical stimulation to pelvic floor muscles to prevent the leakage of urine.
Medical Devices -
Millennial to menopausal, women's health is fertile space for startups
Early-stage investors have increased support for female-specific devices and direct-to-consumer diagnostics in the last five years, as the women’s health market is poised to reach $50 billion globally by 2025.
Medical Devices -
Microsoft issues open source FHIR, moving deeper into health
The software giant recently upped its stake in healthcare with the announcement of a formal unit, Microsoft Healthcare.
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Grassley questions FDA about 'troubling' cybersecurity audit
"Medical devices could be exploited by those same foreign actors to not only interfere with normal device operation, which could cause harm to patients, but also to steal personal medical information," the senator wrote.
Medical Devices -
Deep Dive3D printing poised to disrupt healthcare
Health industry types are "100% convinced, and rightly so, that [3D printing] will be a core part of their business in five to 10 years," ISG's Michael Harmon said.
Medical Devices -
Healthcare will outspend all other industries on R&D by 2020, PwC says
Medtronic is among 23 healthcare companies rated "high-leverage innovators" for its performance on seven key financial indicators.
Medical Devices -
It's final: Amazon pegs NY, Virginia for HQ2 (with a nod to Nashville)
Amazon will split its new North American headquarters over two sites. The city of Nashville is also a surprise winner, landing 5,000 jobs as part of an "operations center of excellence," the company said Tuesday.
Policy & Regulation -
Cardiva's vascular closure system cuts patient recovery times in study
The findings precede an anticipated FDA decision on a premarket approval application for the company's system for multi-vessel closure.
Medical Devices -
Amazon expands catalog of HIPAA-eligible AI services
Amazon Translate, Amazon Comprehend and Amazon Transcribe can now be used in workflows involving personal patient information.
Digital Health -
AliveCor's Apple add-on detects afib at similar rate to costly implant
KardiaBand, a wearable electrocardiogram that retails for under $200, spotted 97% of the cardiac events detected by implantable loop recorders.
Medical Devices -
Quest Diagnostics adds Apple Health integration for lab results
The move follows rival LabCorp's deal with Apple to add a similar integration for iPhone users.
Diagnostics -
FDA clears battery-powered Ebola test for emergency use
The regulatory decision adds to the testing capabilities of public health clinics and treatment centers.
Policy & Regulation -
Athenahealth scooped for $5.7B by Elliot, Veritas after turbulent year
Activist investor Elliott has been pushing for a buyout since it sent athenahealth an unsolicited offer in May.
M&A -
LabCorp loses 2019 Horizon BCBSNJ exclusivity as Quest enters the fray
The deal means the two clinical laboratory giants will compete for some of the New Jersey insurer's members.
Diagnostics -
Stryker closes $1.4B K2M acquisition
The medical device giant says the deal will augment its own spine and neurotechnology offerings.
Medical Devices -
Owens & Minor names interim chairman and CEO
The leadership shakeup comes against the backdrop of consistently disappointing earnings that have seen the company's shares shed 75% of their value under CEO P. Cody Phipps.
Medical Devices -
Monteris modifies brain ablation device to counter safety risk
FDA cleared a new model that features a fiber optic probe designed to stop the original heating problem.
Medical Devices -
Premier to acquire software company Stanson Health for $51.5M
Software-as-a-service provider Stanson's product pipeline includes a tool to give prior authorizations in near real time.
Medical Devices -
Shoulder device sales power Wright to beat-and-raise Q3
Strong growth emboldened the company to raise its outlook for the second successive quarter. Jefferies analysts wrote there is "no reason we can see to suggest Wright can't maintain double-digit underlying sales growth."
Medical Devices