Initos Fertility Monitor is a small device that enables smartphones to perform lab-grade fertility diagnostic tests at home.

Bengaluru-based medical technology startup Inito on Monday announced that its Fertility Monitor has cleared the regulatory pathway of the United States Food and Drug Administration (FDA). This paves the way for the product’s launch in the US, and also allows access to countries that have signed the Mutual Recognition Agreement with the FDA, it said in a statement. Initos Fertility Monitor is a small device that enables smartphones to perform lab-grade fertility diagnostic tests at home, it said. By measuring two fertility hormones in urine – Estrogen and Luteinizing Hormone (LH) along with AI-based data analytics in the app, Inito said it understands the cycle variations for every individual user, giving highly accurate results unique to every woman’s body.

The US FDA maintains strict regulatory control over all medical devices to ensure accuracy and safety for the end-user. Over the course of more than a year, Initos flagship device has been subjected to a series of clinical studies, manufacturing facility set up tests as per GMP standards, and company-wide quality management system, ensuring the reliability and efficacy of the device. “Inito has always been committed to building a global home diagnostic testing company headquartered out of India, and this milestone takes us one step closer to that ambition. The coming years will see home diagnostics become an integral part of the medical ecosystem, and we’re proud to be among the leaders of this revolution,” said Aayush Rai, Co-founder of Inito. Inito said its patented Flat-lens technology allows dozens of diagnostic tests for fertility, diabetes, Vitamin D and Thyroid, among others, on a single device connected to a smartphone. A study by IIT Delhi determined the device to achieve a 99.12 percent correlation with clinical-grade instrumentations which cost up to 100 times more and are ten times bigger, the statement said.

The post Bengaluru startup Inito gets USFDA approval for fertility monitor appeared first on MyMedicPlus.

It is well-known that blood pressure measured in the doctor’s office does not reflect a person’s regular blood pressure levels.

For this reason, about half of American adults are recommended to have their blood pressure measured outside of a clinical setting, according to a new study led by Paul Muntner, Ph.D., professor of epidemiology in the School of Public Health at the University of Alabama at Birmingham. The study found that approximately 104 million Americans should routinely use a blood pressure machine at home to provide backup for—or a contrast with—the results from their visit to the doctor’s office.

According to the study, nearly 93 percent of in adults the United States who have high blood pressure when measured in their doctor’s office and do not take blood pressure medicine should be screened for “white coat hypertension,” a condition where blood pressure spikes when measured at the doctor’s office, but is normal when measured outside of a medical setting. If someone has white coat hypertension, they may not benefit from starting antihypertensive medication.

Researchers also discovered that a third of U.S. adults should be screened for “masked hypertension,” which occurs when individuals do not have high blood pressure based on readings measured in their doctor’s office but do have high blood pressure readings when measured outside of the clinic.

“For some people, a doctor’s office is a place they’re relaxed,” Muntner said. “They are away from job stress, traffic and family issues. Others get anxious they are about to get bad news about their blood pressure—or something worse. Their readings in the doctor’s office cause concern, whereas measuring in a more familiar setting would cause less stress.”

Under the American College of Cardiology and American Heart Association guidelines, people are considered to have high blood pressure if their systolic, or top number, is 130 or higher and their diastolic, or bottom number, is 80 or higher.

In order to ensure people are accurately diagnosed with hypertension, Muntner says, at-home monitoring should be used. While it may seem expensive or tedious to take one’s blood pressure at home, it does not have to be.

Many pharmacies or grocery stores have blood pressure machines customers may use free. Home versions with an electronic inflatable cuff are also available at local drug stores for less than $50.

“The most important thing is to make sure the device has been validated,” Muntner said. “You should also talk to a doctor or a nurse about buying a device and have them teach you how to accurately measure your blood pressure at home.”

Muntner says you should take your blood pressure two times in the morning and two times in the evening for a week at a time. It is best to use a device that records the readings so you do not have to write the results down, and your doctor can see the data at your next appointment.

Ultimately, the most important objective of having people measure their blood pressure at home is to make sure doctors are treating people appropriately.

“Home blood pressure monitoring will better inform the physicians, as well as the patients,” Muntner explained. “That means physicians aren’t starting a patient on medication when they may not have high blood pressure. It also ensures doctors are starting treatment on patients who do have hypertension or are at risk for cardiovascular disease.”

The study was published in Hypertension, the journal of the American Heart Association.

The post Half of U.S. adults should monitor blood pressure at home appeared first on MyMedicPlus.

Some people go to the doctor and find the intake so nerve-wracking their blood pressure spikes. Others find the routine relaxing, as they’re asked to rest for a moment and breathe easy before a blood pressure cuff is wrapped around their arm.

People with borderline hypertension in both categories should confirm the readings by measuring their blood pressure outside their health care provider’s office, according to new research published Monday in the American Heart Association journal Hypertension.

Nearly 93 percent of U.S. adults who have high blood pressure when measured in their doctor’s office and don’t take blood pressure medicine meet the criteria for “white coat hypertension” because their blood pressure is in an acceptable range when re-measured outside a medical setting. Meanwhile, about a third of U.S. adults experience “masked hypertension” because their blood pressure levels measured outside of the doctor’s office are more problematic than measurements at the doctor’s office.

“For some people, a doctor’s office is a place they’re relaxed,” said Paul Muntner, an epidemiologist at the University of Alabama at Birmingham and the study’s senior author. “They are away from job stress, traffic and family issues.”

Others, he said, get anxious they are about to get bad news about their blood pressure – or something worse. Their readings in the doctor’s office cause concern whereas measuring in a more familiar setting would cause less stress.

In either case, the study used the American College of Cardiology and American Heart Association guidelines to determine that as many as 104 million Americans routinely should use a blood pressure machine at home to provide backup for – or a contrast with – the results from their visit to the doctor’s office. People are considered to have high blood pressure if their systolic, or top number, is 130 or higher and their diastolic, or bottom number, is 80 or higher.

Measuring blood pressure outside of a medical setting doesn’t have to be expensive or difficult.

Many pharmacies or grocery stores have blood pressure machines customers can use for free. Reliable home versions with an electronic inflatable cuff can be found at local drug stores for less than $50, and Muntner said the device should be one that already has been tested and validated.

Other options, such as ambulatory blood pressure machines, can be more involved. Those provide readings throughout the day and night and can flag hypertension while people are asleep.

But the sheer size of the population the study suggests should be measuring their blood pressure at home could make it a daunting task to achieve, said Dr. Raymond R. Townsend, who was not associated with the study.

“How many people would be well served by out-of-office blood pressure monitoring? My answer would be virtually anybody,” said Townsend, who heads up the high blood pressure program at the Hospital of the University of Pennsylvania in Philadelphia. “I think that’s a little ambitious.”

The study concedes there are barriers to widespread blood pressure monitoring at home: patient compliance, accuracy of the results, out-of-pocket costs of the device and the time needed to instruct patients on how to take their blood pressure.

What is not subject to debate is the importance of controlling hypertension. The consequences of unmanaged high blood pressure can include heart disease, stroke and organ damage.

And, Muntner said, the study makes a case that there is a benefit to getting more people to check their blood pressure on their own.

“For individual patients, hopefully it means people will be more engaged with their own health care and not just when they go to the doctor’s office.”

The post Half of U.S. adults should monitor blood pressure at home, study says appeared first on MyMedicPlus.