FDAnews Device Daily Bulletin

Any future guidance on pediatric X-ray devices should take into account that most imaging devices at one time or another will be used for children, a roundtable of experts told the FDA during a July 16 public workshop.

The FDA is developing new methods and laboratory expertise to aid reviewers in identifying potential vulnerabilities and assessing risk-mitigation measures for medical software.

Sensors for detecting chemical biomarkers that indicate a disease have already been applied to some maladies, but they have not proven very effective at discovering low concentrations of those biomarkers, such as when a disease is in its early stages.

Philips Healthcare recalled its Xcelera Connect cardiovascular patient data reporting system after the company discovered a flaw that could result in patient misdiagnosis and improper treatment decisions.

Anaxsys announced the filing of a 510(k) premarket notification with the FDA for regulatory clearance for respiR8 continuous respiratory rate counter.

Research and development by Flinders University’s Medical Device Partnering Program has resulted in a new touch screen therapy and assessment product for Adelaide-based vision rehabilitation company Neuro Vision Technology Systems.

It may seem like a very small thing. But the adhesive tape that healthcare workers use on bandages to bind and protect wounds is undergoing a whole new makeover, and at the same time, seeing a surge in global sales.

North suburban medical products supplier Medline Industries is facing 18 claims from patients stemming from a counterfeit batch of surgical mesh, a sign of the safety challenges faced by the healthcare industry.