MassDevice12h
J&J’s Abiomed updates Impella RP instructions in Class I recall
The FDA today issued a notice informing customers of updated instructions for the Johnson & Johnson Abiomed Impella RP heart ...
drugdeliverybusiness7d
FDA warns of potential missed alerts with smartphone-connected diabetes devices
The FDA today issued an alert around a safety concern regarding diabetes devices that rely on smartphones to deliver critical ...
Forbes14d
2025 Medical Device Cybersecurity Trends: What Will Shape The Industry?
The future of medical devices has much potential, but they also have risks related to cybersecurity. In 2024, we saw the first full year of the Food and Drug Administration’s (FDA) new guidance ...
The National Law Review15d
FDA Releases Draft Guidance on AI-Enabled Medical Devices
You are responsible for reading, understanding, and agreeing to the National Law Review's (NLR’s) and the National Law Forum LLC's Terms of Use and Privacy Policy ...
medtechdive15d
FDA warns about patient monitor cybersecurity vulnerabilities
The notice, which the FDA published Thursday, describes three vulnerabilities that can allow people to gain access to remote monitoring technology and potentially manipulate the devices. The FDA is ...
GitHub17d
NI VeriStand Custom Device Wizard
The scripting code uses a LabVIEW Class-based design that allows you to easily add support for creating new custom device project templates. Branches prefixed with dev/ may be rebased, overwritten, or ...
WCVB Channel 5 Boston19d
Lifesaving medical devices being built in Bedford, Massachusetts
LIFE SAVING MEDICAL DEVICE SYSTEMS. THIS IS A CRITICAL CARE LINE. THIS IS WHERE WE MAKE OUR BLOOD GAS ANALYZERS. MARK OLSON IS THE CHIEF MANUFACTURING OFFICER FOR WARFARIN. THIS MASSACHUSETTS ...
NBC News23d
Federal regulations paused, halting FDA's proposed ban on formaldehyde in hair products
Not all chemical hair relaxers include the chemical, but many include ingredients that can release formaldehyde when heated, the FDA said in 2024. Over the years, an increasing number of studies ...
Women's Health23d
The 4 Best Red Light Therapy Devices For Hair Growth, According To A Dermatologist And A Beauty Editor
Doesn't cover the nape of your head Another device that Finney likes is the Hairmax Laserband 82 Comfort Flex. It's FDA-cleared and has seven clinical studies related to its efficacy. But what ...
Newsweek23d
FDA Approves Nasal Spray for Depression
However, it had to be used in conjunction with an oral medication. The FDA has now expanded its approval to include the standalone use of the nasal spray for adults with treatment-resistant major ...
CNN24d
FDA approves standalone use of J&J’s ketamine-derived depression treatment
The U.S. Food and Drug Administration expanded approval for Johnson & Johnson’s nasal spray, Spravato, to allow it to be used as a standalone treatment for patients with severe depression, the ...
Popular Science24d
FDA approves first-of-its-kind nasal spray for severe depression
Johnson & Johnson has announced the FDA’s approval of a first-of-its-kind ... health questions and unregulated clinics. Licensed medical providers have also faced dwindling supplies as a ...