At the heart of every transformative medical technology lies a team navigating the complex journey from concept to clinic. For early-stage medtech startups, this path can be especially daunting—marked by stringent regulations, limited resources, and the constant pressure to get life-saving innovations to patients faster. That’s where Mittal Consulting steps in. Founded by Kristen Mittal … Continued
Successfully bringing a medical device or IVD/Diagnostic to market hinges on more than innovation; it requires a clear and confident grasp of complex regulatory requirements. For many MedTech innovators, that journey is filled with uncertainty, especially when internal expertise is limited or still evolving. CS Lifesciences steps into this critical space as a strategic partner, … Continued
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
Changes in the MedTech industry can happen all of a sudden, but keeping an eye on the right trends can make all the difference. With new innovations, shifting investment landscapes, and evolving regulations, how can industry professionals stay on top? The Zapyrus 2024 MedTech Report by Kevin Saem, Brand Founder of Zapyrus, helps answer that. … Continued
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
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
At MedTech Malta 2024, a panel titled “Regulatory Landscape for Notified Bodies” brought together experts from various sectors of the MedTech industry to discuss the shifting dynamics of medical device regulations in Europe. The panel, moderated by Dr. Julian Fearne, Senior Head of Medical Devices at the Malta Medicines Authority, highlighted the evolving role of … Continued
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
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
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
