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There is a nearly five-year gap between when a new medical device receives FDA approval and is subsequently covered by Medicare.

Mounting cyberattacks against hospitals and clinics and a regulatory push are increasing the pressure on medical-device manufacturers to improve the security of their products. Cyber protections ...

Innovation Process and Industrial System of US Food and Drug Administration–Approved Software as a Medical Device: Review and Content Analysis. Journal of Medical Internet Research , 2023; 25 ...

Under the EU's Medical Devices Regulation (MDR), which came into effect in May 2021, all medical devices, from implants and prosthetics to blood glucose meters and catheters, must meet stricter ...

Medical-device maker Stryker on Monday agreed to acquire Inari Medical , which makes devices that treat patients with venous diseases, in an all-cash deal worth $4.9 billion. Skip to main content ...

There has been a rise in medical waivers in the past decade, with about 17 percent of recruits receiving them in 2022, up from 12 percent in 2013, according to a review by the DOD inspector general.

Kestra Medical Technologies Ltd. has filed for an initial public offering, showing revenue growth that nearly tripled. The maker of wearable medical devices is offering new shares in the IPO ...

WEST CHESTER, Pa.--(BUSINESS WIRE)--Archimedic, a medical device development firm that provides Design, Regulatory, and Go-to-Market services to its clients, has launched OpenQMS, an open-access ...

AdvaMed, a trade association for medical device makers, had pushed the administration in a letter and in meetings to ensure that workers who review those products got their jobs back.

The Biden administration is considering creating a quicker process to review new medical devices for Medicare coverage after a controversial Trump-era rule was scrapped. Officials with the Centers ...

Samsung’s venture investment unit is looking to invest in California-based medical device startup, Exo, in a round that could climb to $100 million, Bloomberg reported, citing anonymous sources.