FDA Grants Donisi De Novo Clearance for Innovative Contact-Free Multiparameter Health Sensing Solution

FDA Grants Donisi De Novo Clearance for Innovative Contact-Free Multiparameter Health Sensing Solution
Contact-Free Health Measurement and Decision Support. Donisi: Changing Lives Without Changing Lifestyles.

 The U.S. Food and Drug Administration (FDA) has granted Donisi‘s revolutionary contact-free multiparameter measurement system de novo clearance, making Donisi the first to bring this innovative technology to the medical market.

In addition to the de novo clearance, the ingenuity of Donisi’s groundbreaking system was recently recognized via the publication of their clinical validation study in the Journal of Medical Engineering & Technology and winning first place in the MEDinISRAEL OpenMED Innovation Competition.

“I’m really proud of our team; we developed a medical device that can change the lives of millions of people. Our novel technology is now recognized and cleared by FDA which is a great accomplishment,” said Donisi CEO, Yair Brosh.

Backed by 26 granted patents, the system applies a combination of proprietary optics, algorithms, and artificial intelligence to remotely detect and analyze surface-level micro-vibrations caused by the workings of internal organs such as heart and lungs.

Clinical results demonstrate Donisi’s technology maintains medical grade accuracy for people with different medical and physical conditions (physique, skin tone, etc.), without needing to remove clothing or connect the patient to wires or patches.

The company continues to develop its system, building ground-breaking solutions to measure and detect additional cardiopulmonary parameters, such as pulmonary congestion, in collaboration with the Cardiovascular Research Center at the Tel Aviv Sourasky Medical Center. Donisi has already undergone the FDA Presubmission process for the identification of atrial fibrillation (AFib) and plans for additional submissions.

“Having been with the company since its first year, I am awed and inspired to be part of the team that is bringing this amazing futuristic technology to life,” said Donisi Chief Medical Officer Dr. Sagi Polani. “This is an exciting step in our path to fulfilling our mission of changing lives without changing lifestyles. As we move forward, I can envision how our medical device will bridge the continuum of care from hospital to home, impacting lives and health,” he continued.

“Chartered Group’s investment in Donisi Health indicates our belief in its development of the innovative optical sensing system that would contribute to resolve various challenges in the healthcare market including the silver tsunami and shift from hospital care to home care,” said Eyal Agmoni, Chairman of Chartered Group Technology Division, Donisi’s lead investor, and Managing General Partner of Japan Israel High Tech Ventures 2. “The medical market’s response to this development has been extremely enthusiastic and we are excited with the progress made by such a dedicated team of experts.”

For more information or to request an interview, please reach out to Donisi Health. 

In Singapore alone, a quarter of all food is lost and wasted in the supply chain. A total of 393,000 tons of fresh fruit and vegetables, marine, meat and dairy products – equivalent to 70 kilograms for every man, woman and child in the country – is lost each year, according to a recent joint study by the Singapore Environment Council (SEC) and Deloitte Singapore. 

And with Asia’s aggregate pharmaceutical market set to grow by 42% between 2018 and 2022 – according to the Economist Intelligence Unit, the region’s entire cold chain logistics infrastructure needs to move up the technological ladder to keep up with demand and new industry pressures. 

Cold chain refers to the storage and transportation of food, drugs, accessories and biological products within specific temperature ranges. 

Such perishable goods are vulnerable to damage and spoilage from harvest or production until it reaches the supermarket shelf or the end-consumer. Consistency of temperature and humidity in an ‘cold chain’ is vital to ensure that products are safe for consumption or medical application. 

Singapore, being a healthcare hub, is seen as a standard bearer for innovations in cold chain logistics. According to the Economic Development Board eight of the ten leading global pharmaceutical companies have facilities in the country. These giants manufacture four of the top 10 drugs by global revenue. 

The cold chain sector is undergoing major new challenges due to the increased business volume, compounded by challenges related to greater emphasis on sustainable energy usage, geography, need to standardise packaging as well as capability and skills of third-party logistics (3PL) players in a highly cost-competitive and time-sensitive environment. 
Some of the innovations to improve efficiency and standards in recent years have revolved around smart warehouse management. They include efforts to improve energy efficiency, maximising space, digitisation of warehouse logistics, mobile pallet racking and use of RFID and robotics. 

Beyond the opportunity to increase capacity, the imminent arrival of 5G will accelerate the adoption of sensors which will lead to faster storage and retrieval via conveyor systems. These will come with a much-higher level of data capture which, in turn, can lead to new insights using Artificial Intelligence. 

Indeed, not just the main logistics giants and 3PL players but customers themselves are demanding visibility of each shipment, down granular detail of precise location and temperature. 

The speed and velocity of business transaction today means that more customers demand the capability to address potential issues before they can cause major damage and react quickly to sudden changes and oversights. 

But even with such innovations, the cold chain is as strong as its weakest link. 

The refrigeration of a chilled or frozen product may have been interrupted for a period somewhere in the cold chain, before being revived. The temperature or humidity may have spiked intermittently even though the product appears to have arrived intact and at appropriate conditions at the final destination. 

While there are various technologies to address this problem, the adoption within the Asian region to date has largely involved higher-value items. It has not reached the mainstream of the industry. Temperature visibility capabilities which are easy and affordable to implement will emerge as a priority as the region strives to raise overall standards. 

A company from Norway, Tag Sensors AS has sought to address these weaknesses through technological innovations such as printable semi-active labels that can constantly monitor temperature with time and geo-location from production to consumer. The tamper-proof data will be uploaded to the cloud, pin-pointing accurately who was responsible in the event of a breach. This could have interesting benefits for the insurance industry. 

Only with constant innovation and technologies that are easy and affordable to use, can the Asian cold chain sector raise overall standardisation and capability. The impact resonates far beyond cost and efficiency; they will help the region address issues of food safety, availability of reliable medical and pharmaceutical products and issues related to climate and sustainability. 

FDA Grants Donisi De Novo Clearance for Innovative Contact-Free Multiparameter Health Sensing Solution
FDA Grants Donisi De Novo Clearance for Innovative Contact-Free Multiparameter Health Sensing Solution
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