The National Law Review1d
CISA and FDA Sound Alarm on Backdoor Cybersecurity Threat with Patient Monitoring Devices
Contec Medical Systems (“Contec”), a global medical device and healthcare solutions company headquartered in China, sells ...
MassDevice1d
Neuvotion wins FDA nod for neuromod wearable
Neuvotion announced today that it received FDA 510(k) clearance for its first product, the NeuStim wearable device.
FDA Urges Device Makers to Bolster Cybersecurity
The FDA asked medical-device makers to fortify products against hackers and malware, citing an uptick in cybersecurity ...
JD Supra2d
FDA Finalizes Guidance on Scientific Information on Unapproved Uses (SIUU) Communications
FDA published a final version of its guidance document, “Communications From Firms to Health Care Providers Regarding ...
JD Supra4d
Finally, FDA’s Final Word on Unapproved Use Communications
On January 7, 2025, the U.S. Food and Drug Administration (“FDA” or “Agency”) released a long-awaited guidance titled, “Communications From Firms ...
Onc.AI Awarded FDA Breakthrough Device Designation for Serial CT Response Score Deep Learning Model
Onc.AI, a digital health company developing AI-driven oncology clinical management solutions using Deep Learning imaging AI, today announced that the U.S. Food and Drug Administration (FDA) has ...