The FDA’s new transparency policy (Part 3)

As transparency and consistency become increasingly emphasized by the FDA, medical device manufacturers must approach their submissions with both thoroughness a...

FDA launches investigation into gene therapy following child death

The U.S. Food and Drug Administration (FDA) has initiated a safety investigation into Takeda’s Adzynma after reports that a child has died during treatment. The...

PMS, Vigilance and Risk Management

Post-Market Surveillance (PMS) is more than complaint handling – it’s a strategic tool for patient safety, regulatory compliance, and continuous improvement. Un...

Plug and play dräneringslösningar

En universalkoppling är en anordning som du placerar i din rörledning, och som ger dig friheten att enkelt och snabbt renovera och byta ut ångfällor. Detta mins...

FDA’s new CSA guidance: transforming software validation for production and quality systems

FDA’s final guidance on Computer Software Assurance (CSA) for Production and Quality System Software marks a significant modernization of software validation practices.

Sarah Lidé: ”Artificial intelligence must not replace authentic interactions”

Artificial intelligence must never become a replacement for authentic, even if messy, interactions with our fellow humankind, Sarah Lifé, Deputy CEO at Medicon ...

ZEISS Smartzoom 100 for Inspection Efficiency

Catch up on our free webinar.

The vaccine has saved 94 million lives – but measles is spreading again

A disease we once believed belonged to the past is now resurging in both Europe and the United States. In the shadow of growing skepticism and declining vaccina...

Discover ZEISS ZEN core – now for electron microscopy

Watch the recording of our free webinar.

The FDA’s new transparency policy (Part 2)

In the second part of our article series on the FDA’s new “radical transparency” initiative, we explore regulatory strategies to navigate the potential impact o...

Achieve Effortless, Standardized Automation with the new ZEISS Automation Interface

Simple interfaces for automated loading of CMMs.

Integrated solutions for liquid handling

Greater efficiency for manufacturers in laboratory automation and many other industries

Security flaw in Swedish breast cancer screening software – woman passed away

A lack of safeguard in Sectra's software led to a woman with breast cancer receiving an incorrect diagnosis. She later passed away. The software is used in 20 o...

FDA vill ha lägre avgifter för bolag som forskar i USA

Den amerikanska läkemedelsmyndigheten FDA föreslår lägre avgifter för bolag som bedriver tidig klinisk utveckling i USA i stället för utomlands.

ZEISS introduces the new Smartzoom 100

The future of digital microscopy for efficient optical inspections.

New Insights into Microscopy

Watch the recording of our free webinar.

Smartzoom 100 – The New Digital Microscope for Maximum Efficiency

Free webinar July 1, 9:00-9:45 AM CEST and 5:00-5:45 PM CEST.

Novo Nordisk cuts ties with Hims & Hers after Wegovy dispute

Novo Nordisk is ending its collaboration with Hims & Hers Health due to concerns about the company’s sales and marketing practices related to the weight-loss drug Wegovy.

Plug and play lösning för ångfällor

Spirax Sarco har en kompakt "allt-i-ett"-lösning när det kommer till installation av ångfällor. Den kompakta lösningen är optimal eftersom du kan installera kul...

A cluster contribution to European life science innovation and competitiveness?

FDA plans to replace animal testing with AI – “Paradigm shift”

The requirement for animal testing in drug development will be phased out and replaced by AI, according to an announcement by the FDA. The decision has been met...

How to Assure Quality within R&D Medical Devices

Free webinar on June 3rd, 2025, 9:00 - 9:45 AM CEST and 5:00 - 5:45 PM CEST.

ZEN core now available for all ZEISS scanning electron microscopes

Introducing intuitive, streamlined SEM control over imaging, analytics, and multi-modal workflows.

Lungforskningsbolag kan andas ut efter fulltecknad nyemission

Medicinteknikbolaget Pexa har beslutat att upprätta kontrollbalansräkning – men genomför också en fullt garanterad företrädesemission för att återupprätta sitt aktiekapital.