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Philips consent decree with FDA will halt sales of sleep apnea devices

Royal Philips NV agreed with the U.S. FDA to the terms of a consent decree focused on its Respironics business, following the recall of millions of its devices over the last few years. Although the details of the decree are being finalized, Philips said it will halt the sales of new continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) sleep therapy machines as well as other respiratory care devices in the U.S. until the conditions of the decree are met. ....

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Australia takes first steps toward meaningful reforms to health technology process

The biopharma industry lauded the first steps the Australian government has taken to widen access for drugs and devices via reforms to the current health technology assessment process that has remained unchanged for 30 years. ....

Health Technology Assessment , Pharmaceutical Benefits Scheme , Medicines Australia , Bioworld Asia , Asia Pacific ,

FDA clears non-invasive Neuralace therapy for diabetic neuropathy

Neuralace Medical Inc. tied up a second U.S. FDA clearance for its Axon therapy, adding painful diabetic neuropathy (PDN) to the chronic nerve pain indication it received in 2021. An ‘electroceutical’ device, Axon employs non-invasive magnetic peripheral nerve stimulation (mPNS) to provide relief without leads, injections or implants. ....

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Truth and Lies - Aurora

Although advertising must continue to play its pivotal role in shaping narratives on social media, brands must remain vigilant in not falling prey to the pernicious dangers of misinformation, argues Oswald Lucas. ....

Oswald Lucas , Digital Advertising , Advertising Budget ,

Amazon calls off US$1.7 billion bid to buy Roomba maker iRobot

Amazon called off its purchase of robot vacuum maker iRobot on Monday, blaming “undue and disproportionate regulatory hurdles” after the European Union. ....

United States , United Kingdom , David Zapolsky , Glen Weinstein , Colin Angle , Margrethe Vestager , European Union , European Commission , Amazon Stores , Federal Trade Commission ,