Smiths Medical issued an urgent field safety notice to warn of corrective action for its LogiCal 5 ml closed blood sampling system sets and HemoDraw Plus closed blood sampling sets with the LogiCal pressure monitoring system. The company said in the notice out of Germany that it became aware that customers using the LogiCal and […]
Report: FDA promise of 1 million coronavirus tests this week unattainable
The FDA grossly overestimated the number of coronavirus diagnostic tests that would be available this week as well as U.S. laboratories’ capacity to process them, according to a report in the New York Times. FDA commissioner Stephen Hahn told reporters on Monday that the agency’s decision allowing private labs to make their own tests would […]
Getinge issues urgent field safety notice for 88-series
Getinge (STO:GETI-B) issued an urgent field safety notice in Europe to warn customers of a potential leakage issue with its 88-5 washer disinfector. According to the safety notice out of Germany, the leakage may occur from the device in ruptured spot welds in the chamber, in some instances due to a worn door seal. The […]
Mölnlycke issues safety notice for procedure trays
Mölnlycke issued an urgent field safety notice to warn of a potential safety issue with its procedure tray containing latex material. During an inspection, the company observed an error on the procedure tray labels. Information on the label states that the tray does not contain “natural rubber latex.” However, some components within the trays do […]
3M issues safety notice for Durapore Advanced surgical tape
3M Deutschland (NYSE:MMM) recently issued an urgent field safety notice to warn of issues with its Durapore Advanced surgical tape. The Maplewood, Minn.–based company said in the notice — reported out of Germany — that its tape product meets all safety and efficacy criteria. However, long-term exposure of the Durapore Advanced surgical tape to continuous high-moisture […]
Ethicon recalls Echelon Flex Endopath staplers
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon yesterday issued a Class I recall of its Echelon Flex Endopath staplers after the product failed to completely form staples. Ethicon recalled the devices due to an out-of-specification component within the jaw of the stapler in some devices, which could lead to malformed staplers. If a problem isn’t recognized or addressed, […]
Staple snafu prompts voluntary Johnson & Johnson recall in Europe
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon initiated a voluntary recall of its Echelon Flex Endopath 60mm staplers across seven different European countries due to potentially malformed staples. The company identified the possibility that some Echelon Flex Endopath staplers may contain an out-of-specification anvil component within the jaw of the device. The issue could lead to malformed […]
Surgical staplers top ECRI’s list of top medtech hazards
ECRI Institute said today that surgical stapler misuse is the top health technology hazard, beating out the likes of point-of-care ultrasounds and sterile processing errors. The ECRI Institute said it intends to help surgical stapler users avoid many of the common errors that can lead to patient harm by publishing the 13th edition of its Top […]
SiO2 brings in $48m in debt offering
SiO2 Medical Products filed an SEC Form D this week revealing that the company pulled in nearly $50 million in a debt offering. The Auburn, Ala.-based company reeled in a total of $48 million, according to the filing. SiO2 is seeking $60 million in the debt offering, with $12 million of the offering remaining to […]
This low-magnetic MRI field produces clear images of the lungs
Researchers at the National Institutes of Health and Siemens developed a low magnetic-field MRI system to improve imaging of the lungs. The high-performance, low magnetic-field MRI system is designed to improve the image quality of the lungs and other internal structures. It is also designed for patients who have pacemakers and defibrillators and is compatible […]
Healthy.io raises $60m in Series C funding round
Healthy.io said today that it completed a Series C financing round worth $60 million and won FDA 510(k) clearance for its smartphone-based ACR test. The funding round was led by Corner Ventures and Joy Capital, as well as previous investors Ansonia Holdings, Aleph and Samsung NEXT. The Tel Aviv, Israel-based company plans to use the […]
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