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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 ...

New version of ISO 10993-1: the core standard for the biological evaluation of medical devices

ISO 10993-1, the core standard for the biological evaluation of medical devices, has been under revision over the past few years. A Final Draft International St...

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...

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...

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.

Could an overly burdensome QMS be the organization’s own doing?

Although the above statement is intentionally somewhat provocative, it does hold a degree of truth. Organizations that are generally negative toward regulations...

IVDR Reality Check: Are We Moving Fast Enough?

As of February 2025, around 1,500 IVDR certificates have been issued. But if an estimated 18,700 devices still need certification before the 2029 deadline, then...

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...

Gene therapy restored hearing in children with congenital deafness

Eleven out of twelve children with congenital deafness showed improvements in a study testing Regeneron’s gene therapy for hereditary hearing loss. The U.S. com...

Billion-Dollar Deal Sends BioArctic Soaring

Swedish Alzheimer-focused company BioArctic has entered into a licensing collaboration with Novartis regarding a technology aimed at enhancing efficient drug de...

ZEISS announces CE mark for CIRRUS PathFinder AI tool with automated OCT assessment

Fully integrated AI decision support tool flags B scans that may require further review, supporting more confident decision making and more efficient patient care.

Multiplex immunofluorescence chemistries with ZEISS tissue multiplexing workflow

Bringing leading multiplex immunofluorescence chemistries together in one automated 8-channel imaging platform.

Anocca raises SEK 440 million ahead of clinical cancer trial

Swedish cell therapy biotech Anocca has successfully raised SEK 440 million in a new funding round to support upcoming clinical trials in pancreatic cancer.

Who pays for Rebecca Doe – and all of us?

Anna Törner on how easily we get used to the idea that healthcare is free - when it really is about how and who pays for it

Canada approves leqembi as global alzheimer’s drug race heats up

Leqembi has secured approval in Canada, further consolidating its global lead among disease-modifying Alzheimer’s therapies. The antibody is now authorized in 1...

Swedish team tests Alzheimer antibody for brain imaging

Recent breakthroughs in Alzheimer’s treatment have increased the need for precise diagnostics in the field. Researchers in Uppsala are working to develop improv...

Life science-bolag pitchade idéer i eget ”Draknästet”

Ett nytt event, arrangerat av Medicon Village, lockade investerare att höra presentationer från life science- och medtechbolag. ”Det fördes diskussioner om intr...

ZEISS showcases comprehensive workflow for full spectrum of retina care at EURETINA

ZEISS Medical Technology combines its diagnostic, surgical and digital technologies to support healthcare professionals in advancing retinal care.

Swedish life science is growing – but capital is not keeping up

The number of employees and companies in Swedish life science is increasing and the sector is more equal than many other sectors. But investments in unlisted co...

Pharma Outsourcing – Find the Right Partner (2025)

Virology professor on the threat from X: ”The next pandemic could be worse“

The question is not if, but when we will be affected by a new unknown virus that causes yet another pandemic. Are we sufficiently prepared? "Absolutely not!", r...