Startoon Labs Private Limited, a Hyderabad-based ISO 13485:2016 and ISO 9001:2015 Certified medical device R&D, Engineering and Manufacturing Company with a focus on Joint health received US FDA (The US Food and Drug Administration) (510 K Exempt) clearance for its revolutionary wearable device PHEEZEE®️.
The US FDA is a regulatory agency that ensures the safety and security of drugs, devices and other products going into the US Market.
Disclosing this in a press note issued in Hyderabad, Suresh Susurla, Founder & CEO said, Pheezee is a patented technology, capable of measuring the surface Electromyogram (sEMG) of bulk muscles and Range of motion (ROM) of primary joints simultaneously, to determine joint health, making it a one-of-a-kind product in the world with this capability.
Pheezee is helpful in assessing joint health during physiotherapy post musculoskeletal, neurological, spinal cord injuries and neuro-ailments such as paralysis, hemiplegia, paraplegia, muscular dystrophy etc. It generates reports, for the first time in the field of physiotherapy, enabling patients to track their recovery. Pheezee, being an IOT-enabled device, enables telerehabilitation of the patients and allows them to continue doing physiotherapy sessions at home and still keep the referring surgeon updated about the progress.
It is a revolutionary device set to transform the way assessments, monitoring and tracking of recovery is done in the field of physiotherapy, says Mythreyi Kondapi Co-founder of the medical technology startup.
The flagship product of the company already enjoys national and international recognition. With USFDA’s nod, its reach is going to be widened even further. Now it will demonstrate its performance in the USA and many other global markets. Utilizing advanced technology like Electromyography and Range of Motion monitoring, Pheezee®️ measures and tracks the recovery of patients post musculoskeletal and neurological ailments. The device finds usage in joint health assessments in multiple musculoskeletal diseases, including arthritis, muscle dystrophy, carpal tunnel syndrome (which affects 64.4% of IT professionals), and many more in their early stages.
It is a proud moment not just for us, but for the entire medtech startup community in the state that Pheezee is now a globally accepted Made in Telangana product. What could be a better moment than this for us at Startoon Labs to see our product go global, said Suresh, a well-acclaimed professional who has 11 international publications to his credit (co-authored).
Startoon Labs is one of the most vibrant startups among 4,000 startups in Telangana.
Pheezee®️ is certified for electrical and environmental safety as per international standards and is a registered medical device with CDSCO – the Regulatory body of Govt. of India. The device is a game-changer in the field of physiotherapy and rehabilitation, Suresh adds.
As a part of the rapidly growing MedTech industry in India, valued at $10.86 billion in 2020, Startoon Labs is at the forefront of the digital technology segment. The sector is poised for growth, at a CAGR of 37% and to reach $50 billion by 2025, he adds.
The major driving forces behind this growth are the Government’s support, increased public spending, penetration of healthcare and internet, medical tourism, growing population, and increased disposable income. Digital technology in the global healthcare sector is estimated to save between $1.5 trillion and $3 trillion by 2030, making it a highly attractive investment opportunity