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FDA Authorizes First Interoperable Insulin Pump Intended to Allow Patients to Customize Treatment Through their Individual Diabetes Management Devices

“Diabetes is a complicated disease that requires close monitoring and carefully tailored treatments. We’ve heard from the patient community that having the ability to customize their own diabetes management devices is important to them. Advances in digital health make more tailored approaches to diabetes care possible,” said FDA Commissioner Scott Gottlieb, M.D. “The marketing authorization of the first ACE insulin pump intended for interoperable use has the potential to aid patients who seek more individualized diabetes therapy systems and opens the door for developers of future connected diabetes devices to get other safe and effective products to patients more efficiently. Because the FDA’s action creates a new regulatory classification, future ACE insulin pumps will be able to go through the more efficient 510(k) review process, helping to advance this innovative technology. We’re committed to advancing new ways to accelerate the development of innovations that can improve patient care while strengthening our pre- and post-market tools for determining the safety and effectiveness of these new technologies.

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FDA Warns Patients and Doctors About Recall of Home-use Test Strips Used with Device to Monitor Blood Thinner Warfarin, Not Authorized for Sale in U.S.

“Monitoring warfarin dosing is a critical part of using the drug properly to prevent and treat blood clots. Using faulty strips can lead to errors in medication dosage that could cause serious harm or death in some patients. That’s why it’s so concerning that this distributor continued to sell these test strips in the U.S. even though domestic sales had been stopped due to safety concerns. To reduce risks to patients, we’re warning health care providers and the public about the dangers associated with this product,” said FDA Commissioner Scott Gottlieb, M.D. “Distributing products that are not labeled or authorized for sale in the United States raises significant concerns for us in view of the serious safety issues with these test strip devices, and our work on this matter is not finished. Our top priority is the immediate safety of patients, and we’re taking steps to ensure the products that this company distributed are removed from the market.”

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SEC Charges Four Public Companies With Longstanding ICFR Failures

According to the SEC’s orders, year after year, the four companies disclosed material weaknesses in ICFR involving certain high-risk areas of their financial statement presentation. As discussed in the SEC orders, each of the four companies took months, or years, to remediate their material weaknesses after being contacted by the SEC staff. One of the companies is still in the process of remediating its material weaknesses.

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Kimberly-Clark Announces Voluntary Recall of U by Kotex® Sleek® Tampons, Regular Absorbency, Throughout U.S. and Canada USA – English

Kimberly-Clark has received reports from consumers of the U by Kotex® Sleek® Tampons, Regular Absorbency, unraveling and/or coming apart upon removal, and in some cases causing users to seek medical attention to remove tampon pieces left in the body. There also have been a small number of reports of infections, vaginal irritation, localized vaginal injury, and other symptoms.

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Two Advisory Firms, CEO Charged With Mutual Fund Share Class Disclosure Violations

"Advisers must be vigilant in disclosing all conflicts of interest arising from compensation received based on investment decisions made for clients," said C. Dabney O'Riordan, Chief of the SEC Enforcement Division's Asset Management Unit. "The documents these advisers provided to clients were incorrect and investors were harmed. We are continuing our efforts to stop these violations and return money to harmed investors as quickly as possible."

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Brexit Uncertainty to Continue for at Least Another Two Months

A Statement from The Conference Board Press Release Provided By The Conference Board Jan 16, 2019, 07:35 ET NEW YORK, Jan. 16, 2019 /PRNewswire/ — The British parliament took a decisive step today in the Brexit divorce process to not support the plan negotiated by Prime Minister May with the European Commission. Uncertainty has dominated the entire process until now …

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