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Australia’s Therapeutic Goods Administration is seeking industry input on whether it should adopt the EU Medical Device Regulation on nanomaterials in medical devices. Read More
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said that paclitaxel drug-coated balloons or drug-eluting stents should not be used in the routine treatment of patients with widening of the arteries, as the mortality risk generally outweighs the benefits. Read More
The FDA is warning devicemakers that have been touting phony FDA registration certificates that give the false impression that their products have been cleared by the agency. Read More
The FDA appears to be putting on the brakes to many requests for emergency use authorization (EUAs) for COVID-19 diagnostic tests, and industry experts say the FDA could be doing more to inform industry. Read More
The alternative technology “introduces a new environmentally friendly means of sterilization to an industry that is decades deep in carcinogenic emissions,” ClorDiSys said. Read More
According to AFYX, the device is the first biodegradable oral adhesive patch designed to locally deliver clobetasol, a corticosteroid used for skin conditions, to treat oral lichen planus lesions. Read More
Enso’s device uses high-frequency pulses to provide more immediate and long-lasting pain relief, delivering nonaddictive pain relief within seconds, Hinge said. Read More
The RapidFill system uses the company’s Shape Memory Polymer technology, a porous scaffold that is crimped for catheter delivery and expands upon contact with blood to rapidly clot it. Read More
The viral RNA placed in the device is stabilized at an ambient temperature for up to 28 days for evaluation by reverse transcription polymerase chain reaction (RT-PCR). Read More