Real-world evidence (RWE) can be especially difficult to gather for medical devices, the UK’s National Institute for Health and Care Excellence (NICE) points out in a new “framework” document on the topic. Read More

The FDA has granted 510(k) marketing clearance to Invictus Sterilization’s Aura Storm hospital-grade ultraviolet medical air purifier. The North Carolina-based company makes surface and air sterilization products that use ultraviolet C light. Read More

The FDA emphasizes the need for high-quality approaches to developing and modifying clinical outcome assessments (COA) for clinical trials of medical devices, in a draft guidance released yesterday. Read More

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) announced that it is planning new device regulations aimed at improving patient safety and encouraging innovation. Read More

Philips issued an update on the status of the June 14, 2021 recall of its Philips Respironics’ continuous positive airway pressure (CPAP), bi-level positive airway pressure (BiPAP) and ventilator devices, citing ozone cleaning as a possible contributor to the problem. Read More

Australia-based CardieX and its manufacturing partner Andon have filed a 510(k) premarket submission with the FDA for the CONNEQT Pulse, the world’s first dual blood pressure and arterial health monitor. Read More