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.

By Nick Paul Taylor • Nov. 15, 2018

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.

By Nick Paul Taylor • Nov. 15, 2018

Explore the Trendline➔

Top 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

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.

By Nick Paul Taylor • Nov. 15, 2018

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.

By Maria Rachal • Nov. 14, 2018

Atlantic gains FDA nod for wearable incontinence device

The device delivers electrical stimulation to pelvic floor muscles to prevent the leakage of urine.

By Nick Paul Taylor • Nov. 14, 2018

Medtronic gets CE mark for low-profile thoracic endograft

The clearance comes weeks after FDA approved the Valiant Navion TEVAR endograft.

By Nick Paul Taylor • Nov. 14, 2018

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. 

By Meg Bryant • Nov. 13, 2018

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.

By Nick Paul Taylor • Nov. 13, 2018

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.

By Nick Paul Taylor • Nov. 13, 2018

3D 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.

By Meg Bryant • Nov. 12, 2018

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​.

By Nick Paul Taylor • Nov. 11, 2018

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.

By Susan Kelly • Nov. 9, 2018

Stryker closes $1.4B K2M acquisition

The medical device giant says the deal will augment its own spine and neurotechnology offerings.

By David Lim • Nov. 9, 2018

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.

By Nick Paul Taylor • Nov. 9, 2018

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.

By Meg Bryant • Nov. 8, 2018

Rising Cordis costs drag on Cardinal Health profits

Increased expenditures at the troubled medical device unit stifled profitability.

By Nick Paul Taylor • Nov. 8, 2018

BD posts long-awaited clinical data on Lutonix balloon in CLI

If the approval and commercialization go to plan, BD thinks the below-the-knee opportunity is worth about $250 million a year.

By Nick Paul Taylor • Nov. 8, 2018

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."

By Nick Paul Taylor • Nov. 8, 2018

Long-term data backs Medtronic drug-coated balloon for PAD

Five-year study data on the company's Admiral device to treat peripheral artery disease showed it continued to outperform standard angioplasty.

By Susan Kelly • Nov. 7, 2018

Fresh off of strong quarter, ResMed buys MatrixCare

The sleep apnea company is betting the acquisition will augment its existing software-as-a-service offerings such as Brightree and HEALTHCAREfirst.

By David Lim • Nov. 6, 2018

Becton Dickinson Q4 revenue up, some Wall Street misses

The device company aggressively remade itself in recent years to focus on higher-growth areas within the medical technology sector.

By Susan Kelly • Nov. 6, 2018

Abbott, J&J take part in FDA's NEST real world evidence pilot

The test cases will assess the role of RWE in proactive post-market surveillance, the evaluation of ablation devices and other activities across the medical device lifecycle.

By Nick Paul Taylor • Nov. 6, 2018

FDA approves 2 devices to aid in thyroid surgery

The products sold by Fluoptics and AiBiomed are designed to help surgeons locate parathyroid tissue or glands, which can be difficult to see during a procedure.

By Susan Kelly • Nov. 5, 2018

FDA extends time to comply on unique device identification

The agency said it is extending the compliance date for Class I and unclassified devices in response to industry concerns that reworking devices in inventory would be a costly burden.

By Susan Kelly • Nov. 5, 2018

Gap between perception, reality of connected medical device security, survey finds

Nearly two-thirds of health IT professionals trust traditional security measures like firewalls to protect connected medical devices from cyber attack, according to a new Zingbox survey, but that trust may be misplaced.

By Meg Bryant • Nov. 2, 2018