Amid Reforms, Brexit, UK IVD Firms Battle Funding And Adoption Issues

The EU In Vitro Diagnostics Regulation and Brexit loom large for UK IVD companies, but manufacturers serving the $1.6bn UK IVD market have many other competing concerns. It’s the most challenging period in more than 15 years, according to the British In Vitro Diagnostics Association Chief Executive Doris-Ann Williams.

Brexit is understandably the talk of the town, yet there's still nothing to say of any gravity about it, nine months on from the UK's vote to leave the EU. So says Doris-Ann Williams MBE, chief executive of the British In Vitro Diagnostics Association (BIVDA), speaking to MedTech Insight early in the month that UK Prime Minister Theresa May finally invoked Article 50 of the Treaty of Lisbon, thereby beginning the divorce talks between the UK and the EU and its remaining 27 member states.

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Cambridge, UK-based breath biopsy company Owlstone Medical will apply its volatile organic compound analysis platform in an attempt to develop a test for the identification and monitoring of pseudomonas aeruginosa in patients with cystic fibrosis.

Wired Health: Women Of Wearables Shares Market Outlook

 

Medtech Insight sat down with Anja Streicher, chief marketing officer at Women of Wearables, a global community offering events and education resources to support the femtech industry, to discuss trends in the women's wearables tech market, challenges and innovators pushing the boundaries.

Medtech Regulatory System, IDAP And CERSI Top UK MHRA Agenda In March Update

 
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Britain’s medtech system progress, smarter ways of working at the agency and getting smarter AI and digital technologies into circulation for patients, were themes woven through the UK MHRA board’s 18 March meeting.

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Wearable technology must address women’s unique needs, said Anja Streicher, Women of Wearables chief marketing officer. Samphire Neuroscience and Amira Health demo wearable solutions for PMS and hot flashes at Wired Health.

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EU Commissioner: Medtech Regulations Assessment To Wrap Up by End 2025

 

Pediatric devices and IVDs are to be a priority. And the European Health Data Space regulation is seen as critical in supporting digital technologies and AI in transforming care.

Rapid Action Required For Medtech Compliance With EU Batteries Regulation

 

As deadlines approach, the regulatory landscape for medtech batteries is set to change, with an emphasis on sustainability and ethical practices.

Owlstone Medical Develops P.aeruginosa Breath Test For Cystic Fibrosis Patients

 

Cambridge, UK-based breath biopsy company Owlstone Medical will apply its volatile organic compound analysis platform in an attempt to develop a test for the identification and monitoring of pseudomonas aeruginosa in patients with cystic fibrosis.