US-based Hyperfine has signed a distribution agreement with Radiosurgery Global to bring the Swoop portable magnetic resonance (MR) brain imaging device to India, expanding its global reach.
The Swoop system, which received 510(k) clearance in the US in 2020, claims to have the highest-performing software so far in terms of image quality and usability.
Last year, the company achieved CE certification under the EU MDR and UKCA certification in the UK for its latest hardware and eight-generation AI-powered software.
Earlier this month, Hyperfine appointed distributors in France, the UK and Italy, and is now collaborating with Radiosurgery Global to support marketing submissions in India.
The distribution agreement with Radiosurgery Global also covers countries such as Indonesia, Malaysia, and Singapore.
Hyperfine president and CEO Maria Sainz said: “Expanding commercially to Asia with a focus on India is an important element of our international strategy.
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“We have begun preparing for the regulatory approval process through the CDSCO and are excited to partner with an experienced and capable group like Radiosurgery Global to drive commercial impact in 2025 and beyond.”
By integrating ultra-low-field magnetic resonance technology with AI, the Swoop system has the potential to facilitate quicker treatment decisions, expedite patient discharges, and optimise the use of hospital staff and resources.
The Swoop Portable MR Imaging system is equipped to provide images of the head’s internal structure when a full diagnostic examination is not feasible.
Radiosurgery Global managing director Timon Dressler said: “The innovative Swoop system aligns perfectly with our mission to democratise healthcare access in over 69,000 public and private hospitals across India, providing clinicians with unprecedented diagnostic imaging capabilities even in the most remote areas.”
The system is ideal for brain imaging in paediatric facilities, intensive care units, and other healthcare settings.
