In a First of Its Kind, Samsung Galaxy's Feature Which Detects Signs of Sleep Apnea Gets US FDA Authorization

Samsung Electronics announced that the sleep apnea feature¹ on the Samsung Health Monitor app² has received De Novo authorization from the U.S. Food and Drug Administration (FDA). This feature, which detects signs of sleep apnea using a compatible Samsung Galaxy Watch and phone, was the first of its kind to be authorized by the FDA following previous approval by Korea’s Ministry of Food and Drug Safety (MFDS), announced last October in Korea.

The sleep apnea feature enables users over the age of 22 who have not been diagnosed with sleep apnea to detect signs of moderate to severe obstructive sleep apnea (OSA) over a two-night monitoring period, a common and chronic sleep condition that often goes undiagnosed and untreated. To utilize the feature, users can simply track their sleep twice for more than four hours within a ten-day period.

OSA causes a person to stop breathing while sleeping and can often result in disruptions in oxygen supply, decreased sleep quality and increased daytime fatigue. Untreated sleep apnea can compound the risk of cardiovascular diseases such as hypertension, coronary artery disease, heart failure, cardiac arrhythmia and stroke. According to the National Sleep Foundation (NSF), roughly 25% of men and 10% of women in the U.S. experience OSA. The new feature on the Samsung Health Monitor app is expected to help more people proactively detect moderate or severe forms of OSA, and as a result of the detection seek medical care to reduce the possibility of health-related complications.

Good health is strongly linked to good sleep. Sleep helps bodies and minds recover and empowers people to wake up refreshed and ready for the day ahead. The quality of sleep people get every night has a significant impact on their physical and mental well-being, relationships, performance and more. Samsung recognizes the foundational role that sleep serves in people’s health and well-being by focusing on three key elements for better sleep: understanding sleep patterns, building better habits and creating a sleep-friendly environment.

With the sleep apnea feature, Samsung is taking the next step in its ongoing commitment to provide Galaxy users with the best possible sleep tools to improve their sleep health habits. The feature will be available on the Galaxy Watch series in the U.S. via the Samsung Health Monitor app in the third quarter.³

1 The Sleep Apnea Feature is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and phone. This feature is intended to detect signs of moderate to severe obstructive sleep apnea in the form of significant breathing disruptions in adult users 22 years and older, over a two-night monitoring period. It is intended for on-demand use. This feature is not intended for users who have previously been diagnosed with sleep apnea. Users should not use this feature to replace traditional methods of diagnosis and treatment by a qualified clinician. The data provided by this device is also not intended to assist clinicians in diagnosing sleep disorders.
2 Availability may vary by market or device. Due to market restrictions in obtaining approval/registration as a Software as a Medical Device (SaMD), it only works on watches and phones purchased in the markets where service is currently available (however, service may be restricted when users travel to non-service markets).
3 Availability may vary by market, carrier, model, or paired phone.

For Its Blood Test to Detect Early-stage Prostate Cancer, Mumbai-based Datar Cancer Genetics Gets 'Breakthrough Designation' from the US FDA

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The US FDA grants the coveted Breakthrough Designation for Early-Stage Prostate Cancer Detection Blood Test Developed in India by Datar Cancer Genetics

It is the first blood test able to detect early-stage Prostate Cancer with high accuracy in men aged 55 years and above

Datar Cancer Genetics today announced that the US Food and Drug Administration (FDA) has granted 'Breakthrough Designation' for its blood test to detect early-stage prostate cancer. This is the second test from Datar Cancer Genetics that has received the Breakthrough Device Designation from the US FDA. Late last year, Datar Cancer Genetics’ breast cancer detection test became the first such test to receive the designation.

This is the first blood test for men which can detect early-stage prostate cancer with high accuracy. The test is available in India by the name of Easycheck. Men with serum PSA of more than 3 ng / mL can avail of this test in consultation with their physician. The test requires 5 ml blood and does not involve exposure to radiation or any of the discomforts of a digital rectal examination. 

The blood test is based on the detection of Circulating Tumor Cells (CTCs) specific to prostate adenocarcinoma. The test can detect early-stage prostate cancers with more than 99% accuracy without any false positives. The test has been validated in large clinical studies involving healthy males and prostate cancer patients.

In India, about 35,000 men were detected with prostate cancer in 2020 and this number is slated to increase every year, as is the case for all cancers due to various risk factors. Unfortunately, most prostate cancer cases are detected at late stages (III or IV) where it has spread to other organs. In such cases, curative surgeries that can remove the cancerous tissue are not viable options, and treatment involves long-term administration of anticancer drugs to manage the disease. If detected at early stages where cancer has not spread out of the prostate, prostate cancer has a very high (>99%) chance of being cured.

"About 75% of prostate biopsies are benign and with foreknowledge, these could be potentially avoided. The new blood test by the Datar team will help Doctors decide precisely the patients who need a biopsy and who do not. This is a very significant scientific advancement in the complex field of liquid biopsies coming from India. I congratulate the Datar team for their exemplary work and achievement," said Dr. Sewanti Limaye, Director of Medical and Precision Oncology and Oncology Research, Sir HN Reliance Foundation Hospital and Research Centre, Mumbai.

"It is a landmark acknowledgement that the US FDA has recognized the potential benefits of our 'first in the world' prostate cancer detection test. The highly coveted 'Breakthrough Designation' is granted after very rigorous evaluation. We take great pride in the fact that this test has been wholly developed in India and by Indian scientists and clinicians. This is our ongoing contribution to the Prime Minister's 'Atmanirbhar Bharat' mission after the breakthrough breast cancer detection test and is further intended to augment the global fight against cancer," said Mr. Rajan Datar, Chairman of the Company.

Appreciably, getting the test does not involve having to go to any hospital or health centre and waiting for appointments. The blood collection for this test can be done in the convenience and privacy of one's home or office after which the patient can go about their routine work. From the patient's point of view, the whole process is very non-intrusive.

The test is already available in Europe and is CE marked. The Company is in discussions with several leading healthcare providers for ready accessibility in India.

About Datar Cancer Genetics

Datar Cancer Genetics is a global oncology research and applications company that is spearheading the development of non-invasive technologies for improved detection, treatment and management of cancer. The Company's state-of-the-art cancer research centre is NABL, ISO, CAP and CLIA accredited. The Company serves cancer patients and suspected cases in the UK, European Union, United States, GCC, and India.