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FDA Grants 510(k) Clearance to Roche’s Tina-quant Molarity Assay

By Ms. Wara Samar

Roche has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Tina-quant Lipoprotein (a) Gen.2 Molarity assay, marking a milestone in cardiovascular diagnostics. This clearance makes it the first assay in the US to measure lipoprotein (a), or Lp(a), in nanomoles per litre (nmol/L).  Lp(a) is a key biomarker in assessing … Continued

President Trump’s Return: Implications for the MedTech Industry 

By Ms. Wara Samar

President Donald Trump’s second tenure in the White House has brought with it a wave of executive orders that are poised to influence U.S. policy across numerous sectors, including MedTech. Among the most significant actions is the withdrawal of the United States from the World Health Organization (WHO). This decision, citing dissatisfaction with the organization’s … Continued

UAE Tightens Pharmaceutical Regulations with New Law and Up to Million-Dirham Penalties

By Ms. Wara Samar

The UAE Government has introduced a landmark Federal Decree-Law aimed at regulating medical products, the pharmacy profession, and pharmaceutical establishments. This comprehensive legislation represents a significant step toward solidifying the UAE’s position as a globally trusted hub for the pharmaceutical and medical industries while ensuring adherence to international standards. The Decree-Law seeks to enhance pharmaceutical … Continued

Navigating Regulatory and Commercial Hurdles Across Borders: Insights from the MedTech Malta Luncheon

By Garance Limouzy

Today, at the Mediterranean Conference Centre in Valletta, Malta, a select group of industry leaders and decision-makers gathered for an exclusive luncheon on the critical topic of cross-border regulatory and commercial hurdles. Held as part of the MedTech Malta 2024 conference, this invite-only event, was hosted by Goodwin, a global law firm renowned for its … Continued

VIP Luncheon and Seaside Chat on Navigating Regulatory and Commercial Hurdles Across Borders at MedTech Malta 2024

By Ms. Wara Samar

MedTech World is excited to announce an exclusive invite-only luncheon event happening on Day 1, November 7th, at The Mediterranean Conference Centre during MedTech Malta 2024. The luncheon will take place from 12:45 PM to 1:45 PM and will include a seaside chat focused on “Gateway to the U.S.: Navigating Regulatory and Commercial Hurdles Across … Continued

All You Need to Know About Emirates Drug Establishment (EDE): UAE’s New Regulatory Body

By Ms. Wara Samar

Emirates Drug Establishment (EDE) is the UAE’s newly appointed independent regulatory body overseeing the pharmaceutical and medical device industries. This strategic move, effective from 30 September 2023, represents a significant step forward in ensuring the country’s long-term healthcare innovation and regulatory integrity. The formation of the EDE, replacing the regulatory functions previously held by the … Continued

Six Challenges That Remain in the Operating Room: New Report

By Team Consulting

Device ergonomics, risk of sharps injuries and laparoscopic visibility – these are just some of the challenges that NHS surgical staff highlight in a new report from medical device consultancy Team Consulting. The report, which draws on insights from a range of surgical staff in the NHS, highlights the common challenges surgeons face in the … Continued