The FDA launched The Adverse Event Monitoring System (AEMS), calling it a major achievement in the agency’s mission to modernize and provide radical transparency into the safety of regulated products.
The post FDA Launches New Adverse Event Look-Up Tool appeared first on MedTech Intelligence.
FDA final guidance titled Medical Devices with Indications Associated with Weight Loss – Premarket Considerations.
The post FDA Issues Final Guidance on Medical Devices with Indications Associated with Weight Loss appeared first on MedTech Intelligence.
A persistent tension exists between the drive for rapid technological advancement, the mandate for government oversight, and the paramount importance of patient safety. It is a foundation for the U.S. Food and Drug Administration's (FDA) 510(k) premarket notification process, the primary pathway for new devices to enter the market.
The post The 510(k) Pathway in 2026: Navigating a Shifting Regulatory and Political Landscape for Medical Devices appeared first on MedTech Intelligence.
Dumi explored the tension between turmoil and resilience in a compact fall outing that hinged on her sharp off-kilter tailoring and dense details.
Alessandro Michele revisited Valentino's grandeur in his "Interferenze" collection.
Shares of the specialty retailer jumped 50 percent on Thursday.
That's according to a YouGov 2026 report on U.S. fashion retailer rankings.
The 2023 LVMH Prize winner will bring his technical and tailoring skills to the French outdoor brand.
The pop-up runs from March 12-15, while over the weekend there will be a tailor on hand to customize scarves and trenchcoats.
Fragrance and hair categories drove fourth-quarter growth, but stock dipped amid modest fiscal 2026 outlook.
Taiwanese footwear manufacturer Yue Yuen said shoe shipment volume fell 1.2 percent to 252.2 million pairs due to more cautious ordering policies by brands.
A bizarre and ultimately unsuccessful Nike marketing initiative rears its head again.
She wore all-white heels with a matching dress.
Iran-linked hackers claim cyberattack launched against U.S. medtech company Stryker.
The post Stryker Cyber Attack Being Reported as Iranian War Retaliation appeared first on MedTech Intelligence.
The partnership supports the Levi's brand's continued global expansion in women's.
The artist discusses the publication of his nonfiction book that traces his ascent into the art world, and "Various Thoughts," his exhibition of new work at Perrotin Gallery in New York.
Trump’s apparent affinity for Florsheim shoes took over the internet this week.
In 2025, Ferragamo’s margins progressively improved in the second half of the year.
Featuring a clean look similar to England's white home kits.
CEO Matt Baer’s turnaround is sustaining its momentum.
