Hosted on MSN1h
BD business split ‘may prefigure’ life sciences division selloff
GlobalData’s director of therapy research & analysis in medical devices says the new entity could make an attractive ...
JD Supra2h
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 ...
FDA issues most serious type of recall for oxygen concentrators spontaneously bursting into flames
A line of oxygen concentrators from a China-based medical equipment company have apparently been spontaneously busting into ...
aha.org5h
FDA warns of potential to miss notifications on smartphone-compatible diabetes devices
The Food and Drug Administration Feb. 5 released an alert notifying patients of a safety concern using diabetes devices such ...
TCTMD5h
FDA Issues Early Alert About Risks of Peripheral Atherectomy Device
Fractures and breakages of the helix on the Rotarex system has led to 30 serious injuries, four deaths, and 115 interventions ...
Healio7h
Q&A: IBD wearable alerts patients ‘in real time’ about impending disease flares
IBD Aware, a wearable medical device in development for patients with inflammatory bowel disease, aims to improve disease ...
Becker's Hospital Review8h
4 recent medical device recalls and corrections
JIANGSU JUMAO X-CARE Medical Equipment Co. issued a recall for the JMC5A Ni/Tru-Aire-5 Oxygen Concentrator after incidents of spontaneous fires. These fires could cause burns or worse. Patients are ...
Benefits Pro9h
AHA warns warn tariffs could disrupt critical medical supply chains, endangering patient care
Tariffs, as well as any reaction of the countries on whom such tariffs are imposed, could reduce the availability of these ...
Healthcare Finance News9h
American Hospital Association says White House should grant tariff exceptions
Pharmaceuticals and medical devices are essential to maintaining safe and effective care in the nation's hospitals and ...
Hackaday10h
This Week In Security: Medical Backdoors, Strings, And Changes At Let’s Encrypt
There are some interesting questions afoot, with the news that the Contec CMS8000 medical monitoring system has a backdoor.
JD Supra11h
State Licensing Requirements: Are You Prepared?
Securing FDA clearance or approval is a major accomplishment for medical device and pharmaceutical companies, but it’s not ...
medtechintelligence12h
Why Quality Culture is the Key for Tech Entrants in Healthcare
W. Edwards Deming Quality culture is a cornerstone of any industry, particularly the healthcare industry where patient lives ...