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Philips (PHG) announces the FDA clearance for its Zenition 30 mobile C-arm, which is intended to aid in image-guided procedures at a relatively affordable cost.
The truth is that if you invest for long enough, you're going to end up with some losing stocks. But the long term...
Under the agreement, the FDA will use rare powers to require repairs, replacements or refunds for recalled respiratory machines.
Philips (PHG) announces a consent decree with the U.S. government and FDA over Respironics' business recalls.
April 10, 2024 Philips confirms that further to communicating the main terms of the Philips Respironics consent decree on January 29, 2024, Philips’ subsidiaries Philips Holding USA and Philips Respironics have now reached final agreement on the consent decree with the DOJ and FDA. As previously stated: The consent decree primarily focuses on Philips Respironics’ business operations in the US.It provides clarity and a roadmap to demonstrate compliance with regulatory requirements and to restore
(Reuters) -A U.S. federal court issued a decree to restrict the production and sale of Philips' new sleep apnea machines at several facilities in the country, the Food and Drug Administration said on Tuesday. The U.S. District Court for the Western District of Pennsylvania has entered into what is known as a consent decree against the company's subsidiary Philips Respironics to curb the sale and production until certain requirements are met. In January, the Dutch health technology company had ...
A U.S. federal court issued a decree to restrict the production and sale of Philips' new sleep apnea machines at several facilities in the country, the Food and Drug Administration said on Tuesday. The U.S. District Court for the Western District of Pennsylvania has entered into what is known as a consent decree to curb the sale and production until certain requirements are met. , the Dutch health technology company had said that it will not sell new devices to treat sleep apnea in the United ...
The company responsible for a global recall of sleep apnea machines will be barred from resuming production at U.S. facilities until it meets a number of safety requirements, under a long-awaited settlement announced Tuesday by federal officials. Philips will be required to overhaul its manufacturing and quality control systems and hire independent experts to vet the changes, according to a court order announced by the U.S. Department of Justice. The action is a major step toward resolving one...
The agreement, filed Tuesday, also has export restrictions to ensure U.S. patients receive remediated devices in a timely manner.
Philips (PHG) partners with smartQare to integrate the latter's viQtor solution, boosting its patient monitoring solutions portfolio.