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Airiver Medical Receives FDA Approval for Clinical Trial on Drug Coated Balloon for Chronic Rhinosinusitis

Airiver Medical Receives FDA Approval for Clinical Trial on Drug Coated Balloon for Chronic Rhinosinusitis

Airiver Medical, a clinical stage company focused on respiratory tract conditions, has received investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA). This approval allows the company to initiate a pivotal clinical trial for its Airiver ESSpand Sinus Drug Coated Balloon (DCB) aimed at treating chronic rhinosinusitis (CRS). The trial will enroll up to 300 patients across the United States, assessing the safety and efficacy of the ESSpand DCB as an adjunct to endoscopic sinus surgery (ESS). The device combines standard balloon dilation with a paclitaxel drug coating to maintain symptom relief and prevent scarring. This study is crucial for Airiver Medical's regulatory submission to the FDA and potential commercialization of the device in the U.S.

FDA Grants IDE Approval to Airiver Medical for Chronic Rhinosinusitis Clinical Study

FDA Grants IDE Approval to Airiver Medical for Chronic Rhinosinusitis Clinical Study

Airiver Medical, a clinical stage company focused on respiratory tract conditions, has received investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA). This approval allows the company to initiate a pivotal clinical trial for its Airiver ESSpand Sinus Drug Coated Balloon (DCB) in patients with chronic rhinosinusitis (CRS). The study will involve up to 300 patients across the United States, assessing the safety and efficacy of the ESSpand DCB as an adjunct to endoscopic sinus surgery (ESS). The device is designed to maintain symptom relief and prevent scarring by applying a paclitaxel drug coating during balloon dilation of sinus drainage passageways. This trial is a critical step towards Airiver Medical's regulatory submission and potential commercialization of the device in the U.S.

Danish Intelligence Identifies U.S. as Security Threat Amid Trump Administration's Greenland Interest

Danish Intelligence Identifies U.S. as Security Threat Amid Trump Administration's Greenland Interest

For the first time, Danish intelligence has identified the United States as a potential security threat to Denmark, citing actions under President Trump's administration. This development follows President Trump's previous suggestions regarding the annexation of Greenland, a move that could have set a precedent similar to Russia's annexation of Crimea. The Danish Defense Intelligence Service (DDIS) has expressed concerns over the U.S.'s shifting role as a security guarantor for Europe, which may embolden Russia to intensify hybrid attacks against NATO. The report also highlights the U.S.'s use of economic and technological power to influence allies, including threats of high tariffs and potential military force, even against allied nations.

Denmark Labels U.S. as Potential Security Concern Amidst Strategic Tensions

Denmark Labels U.S. as Potential Security Concern Amidst Strategic Tensions

Denmark has identified the United States as a potential security concern for the first time in an annual report by the Danish Defense Intelligence Service (DDIS). The report highlights the U.S.'s use of economic power and military force, even against allies, as a growing concern. This assessment is part of a broader analysis indicating that major powers are increasingly prioritizing their own interests. The report also focuses on threats from Russia and China, noting the increased military threat from Russia to NATO and the uncertainty surrounding the U.S.'s role as a security guarantor for Europe. The relationship between Denmark and the U.S. has been strained, particularly after President Trump expressed interest in acquiring Greenland, a move that signaled a shift in U.S. strategic priorities.

Analysis-Contrasting views of Russia show deepening Republican split over foreign policy

Analysis-Contrasting views of Russia show deepening Republican split over foreign policy

By Jonathan Landay and Patricia Zengerle WASHINGTON, Dec 11 (Reuters) - In the past week, President Donald Trump and senior Republican lawmakers have presented starkly different views of a top U.S. national security challenge: Russia, its war in Ukraine and the threat it poses to Europe and the

IMF urges China to address economic imbalances as trade surplus hits $1 trillion

IMF urges China to address economic imbalances as trade surplus hits $1 trillion

The head of the International Monetary Fund has urged China to fix its economic imbalances, echoing longstanding calls for the world's second-largest economy to rely more on domestic spending and investment instead of exports

EU firms in China accelerating supply chain diversification, report finds

EU firms in China accelerating supply chain diversification, report finds

By Laurie Chen BEIJING, Dec 10 (Reuters) - European firms are accelerating efforts to diversify away from Chinese supply chains as Beijing's self-reliance drive and export controls deepen global trade uncertainty, the European Union Chamber of Commerce in China said on Wednesday.

IMF's Georgieva Calls for China to Reduce Export Reliance to Avoid Global Trade Tensions

IMF's Georgieva Calls for China to Reduce Export Reliance to Avoid Global Trade Tensions

International Monetary Fund (IMF) Managing Director Kristalina Georgieva has urged China to accelerate its shift from an export-driven growth model to one that relies more on domestic consumption. Speaking in Beijing, Georgieva emphasized that as the world's second-largest economy, China's continued dependence on exports could exacerbate global trade tensions. She highlighted the need for China to implement its long-standing plan to boost domestic consumption, which would benefit both China and the global economy. The IMF has also raised its forecast for China's economic growth next year to 4.5%, citing domestic stimulus and lower-than-expected tariffs. Georgieva's comments come amid heightened trade tensions between China and the U.S., as well as concerns from Europe and Mexico over the influx of Chinese goods.

Japan's Cybersecurity Lag Raises Concerns Amid Rising Cyber Threats

Japan's Cybersecurity Lag Raises Concerns Amid Rising Cyber Threats

Japan's National Cyber Director, Yoichi Iida, has highlighted the country's lag in cybersecurity compared to the United States and Europe. Speaking at the CYDEF 2025 conference in Tokyo, Iida emphasized the need for significant improvements across Japan's corporate sector to defend against increasing cyber threats. Recent cyberattacks, including a ransomware attack on Asahi Group Holdings Ltd. and a breach at Askul Corp., have exposed vulnerabilities in Japan's cybersecurity infrastructure. Iida noted that smaller companies are particularly vulnerable due to limited resources, but larger firms are also at risk. Japan has recently adopted an 'active cyber-defense' law to enhance its cybersecurity measures, aiming to reach the standards of advanced Western nations. The law allows authorities to neutralize sources of cyber threats and publicize information about attackers to deter further activity.

Coca-Cola names a company veteran as its new CEO

Coca-Cola names a company veteran as its new CEO

Coca-Cola said Wednesday that its chief operating officer will become its next CEO in the first quarter of 2026

EyeYon Medical Ltd. Receives FDA Approval for U.S. Clinical Study of EndoArt for Corneal Edema

EyeYon Medical Ltd. Receives FDA Approval for U.S. Clinical Study of EndoArt for Corneal Edema

EyeYon Medical Ltd., an ophthalmic innovation company, has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to begin a clinical study in the United States for EndoArt, a synthetic endothelial layer designed to treat chronic corneal edema. This device is recognized as a Breakthrough Device by the FDA. The study will be led by Professor Francis Mah, MD, at Scripps Clinic Medical Group, involving at least 10 leading U.S. cornea surgeons. EndoArt has already been adopted in Europe and is undergoing trials in China, with over 800 implantations performed globally. The device aims to provide a new treatment option for patients unsuitable for human tissue implantation.

Wall Street holds steady as Exxon Mobil climbs and AutoZone falls

Wall Street holds steady as Exxon Mobil climbs and AutoZone falls

U.S. stocks are holding relatively steady