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New guidance from the UK’s National Institute for Health and Care Excellence (NICE) says Fisher and Paykel Healthcare’s HumiGard shows promise for preventing hypothermia during abdominal surgery, although there is not enough evidence to support routine use. Read More
Agilent Technologies has receive an expanded CE mark for its Dako PD-L1 IHC 22C3 pharmDx which can now be used to determine PD-L1 expression status to inform the first-line treatment of metastatic non-small cell lung cancer patients with Keytruda. Read More
The European Medicines Agency wants the EU to require better clinical data to support marketing authorization applications (MAAs) for drug-device combination products. Read More
The UK’s National Institute for Health and Care Excellence (NICE) recommended the Intrabeam radiotherapy system (IRS) for treating early invasive breast cancer and HeartFlow FFRCT software for estimating fractional flow reserve from coronary CT angiography. Read More
New guidance from the UK’s National Institute for Health and Care Excellence (NICE) says there is currently not enough validation or clinical-outcome data to determine whether body composition monitors (BCMs) are effective for guiding fluid management in people on dialysis with chronic kidney disease. Read More
The FDA has reclassified antigen-based rapid influenza virus antigen detection test systems (RIDTs) from Class I to Class II devices and has introduced special controls aimed at improving the quality of testing. Read More
In a move that could simplify compliance for devices at risk from cyber threats, the FDA said it will evaluate risk based on the potential for patient harm rather than on clinical performance. Read More
Two manufacturers have asked the FDA to clarify the types of devices covered in the agency’s draft guidance on ultrasound surgical aspirator devices. Read More
Hong Kong’s Department of Heath issued safety warnings for Boston Scientific Ingevity MRI endocardial pacing leads and Percuflex Urinary Diversion stents, Draeger Medical GmbH Oxylog 3000 and Oxylog 3000plus ventilators, and Brainlab radiation treatment software, all of which may have manufacturing or production defects. Read More