Daily Newsletter

11 August 2023

Daily Newsletter

11 August 2023

Acorai’s heart monitor receives FDA breakthrough device designation

Preliminary data from a study involving 281 out of 400 patients has supported the breakthrough device application.

RanjithKumar Dharma August 11 2023

Swiss medical device start-up Acorai has received breakthrough device designation from the US Food and Drug Administration (FDA) for its heart monitor.

The intracardiac pressure monitor (IPCM) is intended to non-invasively estimate mean pulmonary artery pressure, diastolic pulmonary artery pressure and systolic pulmonary artery pressure in patients with Stage C heart failure (HF), who were recommended for haemodynamic monitoring.

Claimed to be the first of its kind, the IPCM device leverages a proprietary machine-learning system and patented hardware technology.

It is designed as a companion test for qualified healthcare professionals.

For detecting haemodynamic congestion and supporting HF personalised treatment, the device can be used in conjunction with standard-of-care assessment in a clinical setting or hospital.

Acorai chief operating officer and co-founder Kasper Bourdette said: “Receiving breakthrough designation is a massive inflection point in our device development journey, and we are thrilled about the decision.”

Preliminary data from a Swedish pilot study involving 281 out of 400 patients has supported the breakthrough device application.

Acorai has obtained ethics approval in five countries, including the US, to conduct a larger study involving 1,200 patients.

This study aims to ensure that the device is generalisable across a global heart failure population.

Acorai CEO and co-founder Filip Peters said: “We could not be more delighted with the decision from the FDA, and it constitutes a huge milestone for us as a company. Congratulations to the entire Acorai team who have worked hard to enable this.”

Healthcare companies are hesitant to invest in the metaverse

The COVID-19 pandemic pushed the healthcare industry to rapid digitalization. Increased use of telehealth, telepresence systems, remote diagnostics, predictive AI, and wearable technology is changing how healthcare is delivered and improving patient outcomes. Emerging technologies such as AR and VR are becoming increasingly routine for professional training, surgical assistance, and treatment of psychological and neurological disorders. In the pharma and medical devices industries, AR, VR, and AI are rapidly accelerating drug discovery and manufacturing and generating supply chain efficiencies. New digital opportunities will look to build upon disruptive technologies. However, affordability is a limiting factor to widespread adoption. Per GlobalData estimates, the metaverse market is expected to grow at a CAGR of more than 33% between 2023 and 2030. Although metaverse technologies could reinvent healthcare approaches and bring new experiences to healthcare providers and patients, adoption is still at an early stage. There are currently few use cases in the healthcare industry. The metaverse needs to overcome major challenges for healthcare, including regulation and data privacy concerns. Evidence of proven use cases and participation by a critical mass of users are imperative to drive a shift in metaverse investment.

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