Visiopharm today announced that Jeannett Hvidkjær has been appointed to its board.

Hvidkjær brings extensive experience from her current position as CEO and Group CFO in LTP Group A/S – a privately held, global business and manufacturing partner for demanding Sport & Outdoor Garments and Contract Furniture brands – as well as her previous position for thirteen years as EVP, CFO for Cooper Surgical Denmark (Origio A/S) – the global leader in IVF and reproductive genetics and part of The Cooper Companies (S&P 500; Symbol COO).

Hvidkjær started her professional carrier in audit services with EY. Hvidkjær has a broad strategic expertise, an international perspective and in-depth knowledge in various areas, within finance and accounting, M&A, establishment of international operations, as well as compliance and risk management.

Hvidkjær holds a bachelor in Business Economics and Accounting, and certificates from INSEAD for Executive Management Programme in Strategy, Innovation and Leadership and Executive Board Programme, as well as various compliance trainings.

Jeannett Hvidkjær said:

“Visiopharm is a unique company with a comprehensive experience and knowledge in AI-driven precision pathology. The technology effectively addresses critical needs in cancer diagnostics and drug development research. I look very much forward to supporting the company in realising its ambitions and I consider it to be a great responsibility and a privilege to become part of Visiopharm’s journey onwards in the market for AI-driven digital pathology solutions.”

Michael Grunkin, CEO, Visiopharm said:

“Strengthening the board with the competencies Jeannett represents, is very timely as we are embarking on a next phase of our journey. The collaboration is already off to a strong start, and I very much look forward to benefit from her extensive financial experience as we continue to scale.”

Visiopharm today announces that Morten Frost has been elected to Visiopharm’s board. Frost was previously announced as board member elect in April 2021.

Frost brings significant strategic consulting, mergers and acquisitions, and global sales and marketing leadership experience. He is currently Chief Commercial Officer at Veracyte, a pioneering genomics diagnostics company based in South San Francisco, California, US, having been promoted from senior vice president and general manager, pulmonology and breast cancer.

Prior to Veracyte, Frost worked at Agilent Technologies in a variety of leadership positions. Most recently he served as head of global marketing in the pathology and companion diagnostics business, which are part of Agilent’s diagnostics and genomics group. Morten held multiple other positions at Agilent including executive positions in the global diagnostic sales organization and working with strategy and business development, focusing on organic and inorganic investments to expand the diagnostic business.

Before Agilent, Frost was a management consultant at IMS Consulting Group (now IQVIA), where he advised leading pharmaceutical companies on top-line growth and commercial strategy.

Morten Frost said:

“Visiopharm is a unique company with a comprehensive experience and knowledge in AI-driven precision pathology. I’m delighted to have been officially appointed member of the board after participating as board observer since April last year. I have had the pleasure to work closely with the executive team and I continue to be amazed by their unique understanding of the clinical unmet needs, superior technical competencies, and the ability to translate these into concrete applications serving the expansive customer base around the world. The demand for digital pathology solutions has never been greater and Visiopharm is uniquely positioned to serve the research segment as well as drive the adoption of novel diagnostic apps into the routine clinical setting.”

Michael Grunkin, CEO, Visiopharm said:

“We’re excited to welcome Morten to the board having served as board member elect since the Spring last year. He has been providing significant input already and is a great asset as we continue our journey in the clinical pathology space.”

Visiopharm, a world leader in AI-driven precision pathology software, today announced that it has passed an important milestone as it progresses towards its goal of getting their existing portfolio of diagnostic APPs certified under the new In Vitro Diagnostic Regulation (IVDR).

The In Vitro Diagnostic Medical Devices Regulation of 2017 bring EU legislation into line with technical advances, changes in medical science and progress in law-making. The new regulations will create a robust, transparent, and sustainable regulatory framework, recognised internationally, that improves clinical safety and creates fair market access for manufacturers and healthcare professionals.

Visiopharm have successfully renewed their ISO 13485 certificate, passed IVDR audit and technical documentation review, and as such are now recommended for their IVD-CE certificate, covering all eight of their diagnostic APPs.

Esther Abels, Chief Clinical and Regulatory Officer, Visiopharm said:

“We’re really pleased to have our ISO 13485 certificate renewed and now be recommended for IVDR certification. We are one of the first companies to achieve this milestone which is an important step for our continued leadership in precision pathology using AI. We will maintain a strong focus over the coming months to ensure we remain on track to achieve our goal to transition our IVD-CE devices from IVDD into IVDR as well as preparing for entering the US market. I would like to thank the team for their tremendous efforts particularly during this challenging Covid time.”

Michael Grunkin, CEO, Visiopharm said:

“This is an important milestone as we continue to expand our presence as a leader in AI-assisted precision pathology within decision support and standardisation. Product quality is a direct link to patient outcomes. We are pleased to see our continued investments and commitment to quality are enabling us to take a lead in the new regulatory environment reflected in the quality demands that IVDR introduces. I want to recognise the excellent work and dedication of the team in achieving this goal.”