Patient monitoring device company CAS Medical Systems, Inc., has received U.S. FDA 510(k) clearance for its next-generation FORE-SIGHT ELITE(TM) Absolute Tissue Oximeter, which it claims is more accurate than its predecessor.
Critical care device company Teleflex Inc, has announced that its Anesthesia and Respiratory business unit has received FDA 510(k) clearance for its ISO-Gard® Mask with ClearAir™ Technology. The company says this novel product helps to reduce clinician exposure to hazardous waste anesthetic gases exhaled in “recovery”.
Vital 5, LLC, a VentureMD portfolio company, has received clearance from the U. S. FDA for ReLeaf™, a first-to-market, dual function catheter system that provides simultaneous anesthetic infusion and wound drainage.
Creative Medical Research (CMR), a fast growing UK-based business focusing on innovative research into the medical device market, has recently begun a comprehensive survey of 100 anaesthetists across Europe into their awareness and prediction of technological advances.
The FDA has seen fit to publicise GE Healthcare’s Class I recall of its T-piece circuit used with its Giraffe and Panda resuscitation units. Customers have been advised not to use the identified parts, although no patient has yet suffered injury as a consequence of device performance.
Teleflex Incorporated has announced the U.S. launch of its new Arrow® FlexBlock™ Continuous Peripheral Nerve Block Catheter at the annual meeting of the American Society of Anesthesiologists, and product will begin shipping to customers in November.
Device company Teleflex Inc. has announced the FDA 510(k) clearance of its Arrow® FlexBlock continuous peripheral nerve block catheter designed for clinicians who use ultrasound guidance when placing peripheral nerve block catheters.
UK’s regulatory authority the MHRA has issued a Medical Device Alert(MDA) pertaining to all lot numbers and product codes of the EMS ET Tube Clamp/Holder because of a risk of airway loss due to slippage of the clamp/holder or airway obstruction as a result of over-tightening of the clamp/holder.
Carefusion is clearly busy with recall issues, three ventilator products having suffered problems in the past year (two in the past month). the company is now updating its guidance on the Enve® recall issued in June.
Maquet is recalling certain of its Flow-i Anesthesia Systems due to a software problem which requires a fix. FDA considers the recall Class I which implies use of the product may cause serious adverse health consequences or death.
Covidien’s acquisition of Oridion Systems Ltd. is complete, expanding the medtech giant’s portfolio of key monitoring technology to include the Israeli company’s capability in airway management.
Israeli airway management specialist ETView Medical Ltd. has announced that the company has received CE Mark clearance for its VivaSight™-DL product family. VivaSight™-DL comprises a dual lumen airway ventilation tube with an integrated, continuous high-resolution video airway imaging system permitting airway control and lung isolation during certain surgical procedures.
Covidien is announcing the global launch of its Nellcor SpO2 module designed for use on Philips patient monitoring platforms.
UK competent authority the MHRA has taken the unusual step of using its medical device alert procedures to remind anaethestists and support staff that their machines and practices need to pass muster if they are to avoid serious patient incidents.
Teleflex Inc. has announced that its Arrow FlexTip Plus Closed Tip, Multi-Port epidural catheter has received FDA 510(k) clearance, bringing claimed reduced complications to epidural catheter insertion.
UK Competent Authority on Medical Devices, the MHRA has issued a medical device alert relating to Nottingham-based Capatex Medical’s Endotracheal tube clamps which it says may result in a risk of airway loss due to slippage or airway obstruction, as a result of over-tightening of the clamp/holder.