World’s First FDA cleared blood pressure smartwatch is available to order

Omron, the household name in blood pressure monitors is about to release the world’s first FDA cleared, medical grade, wearable blood pressure monitor in the form of a smartwatch. Named as HeartGuide, it delivers powerful technology that streamlines the blood pressure monitoring for millions with hypertension.

In combination with the companion app Heartadvisor, the watch can proactively monitor heart rate and overtime track trends with a color-coded display that makes interpretations easier. The real-time heart monitoring generates an algorithm based on a person's daily activity data and can send daily actionable reminders. The app further compares the readings to current American Heart Association/American College of Cardiology guidelines and share data with the healthcare provider.

The watch itself is equipped with a flexible, synthetic band that inflates to measure the blood pressure via oscillometry without the tightening and uncomfortable feeling associated with blood pressure cuffs. It is necessarily a full-size blood pressure monitor that has been shrunk to the size of a wristwatch.

For measuring the B.P., the hand is placed over the heart, and tapping the touchscreen of the watch activates the band. The band starts inflating and displays the B.P. reading in 30 sec. The display is color-coded–green if it is within a normal range and yellow/red if high.

It can be programmed to take blood pressure reading during sleep– a particularly helpful feature as blood pressure readings are most accurate while we sleep.


The Heartguide can also track the heart rate, daily activity, calories burned, and patterns and quality of sleep. Over time if the physical activity is short of daily routine, a reminder is sent.

The watch comes with a 1 Lithium-ion polymer rechargeable battery, that can last up to 48 hours after being fully charged. The battery lasts for 500 cycles when B.P. is measured eight times/day.

Heart conditions are widespread with nearly 40 million people in the US whose blood pressure is uncontrolled. The Heartguide will change the way heart health is monitored and will be a crucial player in support of Omron mission “Going for Zero mission” to eliminate heart attack and stroke.

The Heartguide will be available at retail on January 9, 2019. The device is currently available for preorder for $499.

Omron has a few heart monitoring devices in their pipeline, such as a blood pressure monitor and ECG combo device intended for use in the home.

Here is a promo video of Omron’s Heartguide

 Product page

Ob/Gyn Updated Facebook page

FDA clears the first smartphone camera-based clinical grade at-home urine test

An Israel-based Healthy.io has received FDA 510(k) clearance for Dip.io, a home-based urinalysis kit that transforms the smartphone into a clinical-grade urine diagnostic device. It is the first smartphone-based urine test to secure clearance as a Class 2 device.

Millions of people around the globe such as pregnant women, those suffering from kidney disease, diabetes, high blood pressure and others are required to get their urine tested very frequently- but going to the lab every day is very cumbersome and time-consuming. Dip.io let patient perform urine test in the privacy of their home with results that are equivalent to a hospital-based lab urine test.

The Dip.io kit comes with a cup, dipsticks and patented colorboard. The user simply opens the smartphone apps and is guided step-by-step through the kit by the chatbot nurse named Emily. After peeing in the cup, the user dips the stick and places it on the colorboard. After a lapse of 60 seconds the dipstick and the board are scanned, the image normalized, and data points are sent to the cloud platform to be analyzed and turned into clinical results.

The results are conveyed to the health care provider or directly stored as a part of the patient’s medical record.

The app is straightforward to use as apparent from the tagline “If you can text, you can test,” and has achieved more than 99 percent usability across age groups ranging from 18-80 because of rapid prototyping and repeated user testing. 

The dipstick measures 10 parameters including blood, protein, and glucose in urine and is enormously useful for patients with chronic kidney disease, diabetes, and high-risk pregnancies.

The FDA approval is based on the demonstration of the significant rise in the use of the Dip.io platform by patients of chronic kidney disease as reported by the results of a study initiated by the National Kidney Foundation (NKF) and Geisinger Health.

The Dip.io technology has already been approved by the National Health Trust of UK and is nationally available through the G-Cloud procurement framework. It is also a part of NHS first 'virtual renal clinic' to improve patient convenience and improve cost.

Already commercialized in Europe and Israel since 2016, it is estimated that it will be utilized by 100,000 users by the end of 2018 through different patient pathways, shifting more and more urine testing from labs to homes.

Healthy.io is currently working on expanding the technology for at home assessment of chronic wound through ‘medical-selfies.’

Arming patients with the capability to conduct the critical tests at home with the same accuracy as the lab will curb the tide of many chronic diseases, simplify their daily routine and bring down the healthcare cost significantly.

Press Release

Healthy.io homepage

National Kidney Foundation study

Ob/Gyn Updated Facebook page

Here is a short video about how the product works

Here is an animation describing the company’s intention behind developing the product

Healthy IO (Full Version) from Peepshow on Vimeo.

Yet another warning from FDA against Removal of Uterine Fibroids with Ultrasonic Aspirators

FDA issued a guidance against use of Ultrasonic Surgical Aspirators for removal of uterine fibroids because of risk of unintended spread of uterine cancer in the process of suction by the aspirators, thereby, worsening the patient’s odds for survival.

Ultrasonic aspirators are multifunctional devices that break up and emulsify both hard and soft tissues with ultrasound energy and then suck them out of the body through a small incision. They're used by a wide variety of surgeons in both open and laparoscopic procedures, including the cytoreduction of advanced malignancies that can't be removed completely.

The FDA said that the device’s oscillating tip can disperse the tissue that it breaks up with ultrasonic waves, despite the fact that it is designed to suck up the tissue, and the risk of disseminating cancer cells is outweighed by the aspirator’s benefits, which include “more extensive tumor debulking, little or no collateral thermal damage, and the ability to avoid organ resection.”

However, when it comes to removing uterine fibroids, the risk of spreading occult cancer is not outweighed by the benefits, "particularly since there are alternative treatment options available," the FDA stated. The agency noted that there is "no reliable preoperative screening procedure to detect uterine sarcoma in women with presumed benign fibroids."

Under this guidance, the FDA also requires the manufacturers to add a contraindication label to labeling of the devices, with or without 510(k) clearances, within 120 days of the Oct. 30 release of the guidance: CONTRAINDICATION: This ultrasonic surgical aspirator device is not indicated for and should not be used for the fragmentation, emulsification, and aspiration of uterine fibroids.

ACOG has however openly opposed the FDA guidance against use of ultrasonic aspirators for fibroid removal by stating it to be “too rigid and eliminates patient choice.” ACOG also disagrees with FDA regarding existence of other safer alternatives to remove the fibroids and claims that abdominal hysterectomy carries more risk.

The US FDA  has already issued a communication discouraging the use of power morcellator was issued on April 17, 2014 and have resulted in 4% decline in rate of laparoscopic hysterectomies, says the results of cross sectional study published in forthcoming issue of Journal Obstetrics and Gynecology.

FDA issued the statement because of advocacy and anti-morcellator campaign by Amy Reed, MD, PhD, an anesthesiologist who died because of uterine leiomyosarcoma on Wednesday, May 24 at age of 44.

She underwent a laparoscopic hysterectomy in October 2013 for fibroid, but her undiagnosed, occult uterine leiomyosarcoma was upstaged because of dispersion in abdominal cavity by the use of power morcellator. Since then, the power morcellator is the focal point of a four-year debate that has divided the surgical field.

Based on an analysis of currently available data, the FDA has estimated that approximately 1 in 350 women who undergo hysterectomy or myomectomy for fibroids is found to have an unsuspected uterine sarcoma. 

FDA guidance PDF

Related articles:

Laparoscopic hysterectomies forleiomyomas on decline after FDA communication discouraging the use of power morcellator.

Debate escalates over morcellation ofuterine and fibroid specimens in Minimal Invasive Surgeries after FDA permits the marketing of PneumoLiner!

Power Morcellator: A Boon or Curse?Dr. Amy Reed, a staunch opponent of power morcellator loses battle to uterine cancer.

Laparoscopic hysterectomies for leiomyomas on decline after FDA communication discouraging the use of power morcellator.

The US FDA communication discouraging the use of power morcellator was issued on April 17, 2014 and have resulted in 4% decline in rate of laparoscopic hysterectomies, says the results of cross sectional study published in forthcoming issue of Journal Obstetrics and Gynecology.

FDA issued the statement because of advocacy and anti-morcellator campaign by Amy Reed, MD, PhD, an anesthesiologist who died because of uterine leiomyosarcoma on Wednesday, May 24 at age of 44.

She underwent a laparoscopic hysterectomy in October 2013 for fibroid, but her undiagnosed, occult uterine leiomyosarcoma was upstaged because of dispersion in abdominal cavity by the use of power morcellator. Since then, the power morcellator is the focal point of a four-year debate that has divided the surgical field.

The researchers examined data from 4 states inpatient and ambulatory surgery database for year 2013 to 2014, and compared the rates of laparoscopic hysterectomy 15 months before and 9 months after the FDA announcement.

Women with a diagnosis of leiomyomas who underwent hysterectomy or myomectomy were included in the analysis.

Total 77,637 hysterectomies and myomectomies were performed during that period. The rate of laparoscopic hysterectomies declined from 62% of all hysterectomies before to 58% afterward with an accompanying increase in abdominal hysterectomies of 8% from 71% to 79%.

The rate of myomectomies in women with leiomyoma remained the same as compared to hysterectomies.

On April 7, 2016 The U.S. Food and Drug Administration today permitted the marketing of the first tissue containment system for use with certain laparoscopic power morcellators to isolate uterine tissue that is not suspected to contain cancer.

"PneumoLiner is intended to contain morcellated tissue in the very limited patient population for whom power morcellation may be an appropriate therapeutic option - and only if patients have been appropriately informed of the risks," FDA deputy director William Maisel said in a news release.

"This new device does not change our position on the risks associated with power morcellation. We are continuing to warn against the use of power morcellators for the vast majority of women undergoing removal of the uterus or uterine fibroids," Dr Maisel added.

Based on an analysis of currently available data, the FDA has estimated that approximately 1 in 350 women who undergo hysterectomy or myomectomy for fibroids is found to have an unsuspected uterine sarcoma. 

ACOG statement on power morcellator 

Abstract

FDA approves Noctiva, the first treatment for frequent nighttime urination.

Courtesy: getty images 

The U.S. Food and Drug Administration today approved Noctiva (desmopressin acetate) nasal spray for adults who have to go for urination at least two times per night, a condition known as nocturnal polyuria. [1]

Noctiva is the first FDA-approved treatment for this condition. About 200 million people worldwide suffer from nocturia.

It is manufactured by Serenity Pharmaceuticals, LLC and marketed by Milford, Pennsylvania-based Renaissance Lakewood, LLC.

Hylton V. Joffe, M.D., M.M.Sc., director of the Division of Bone, Reproductive, and Urologic Products in the FDA’s Center for Drug Evaluation and Research said “Today’s approval provides adults who overproduce urine at night with the first FDA-approved therapeutic option to help reduce the number of times a night they wake up to urinate,”  he further added  “It is important to know that Noctiva is not approved for all causes of night-time urination, so patients should discuss their symptoms with their health care provider who can determine the underlying cause of the night-time urination and whether Noctiva is right for them.”

Noctiva can be a symptom of many underlying pathologies of the bladder or prostate, diabetes, side effect of some medications and congestive cardiac failure. It prevalence increases with age and is common in men and women. FDA advises the physician to fully investigate a patient for underlying cause, prescribe medicines and manage the medical condition before putting him/her on Noctiva.

He should also get a 24-hour urine collection to confirm the diagnosis of nocturia.

Desmopressin is a nasal spray, to be taken every day ,30 minutes before bedtime. It acts on Kidneys to increase absorption of water from the tubules.

FDA approved the drug after the results of a placebo control trial of 1050 subjects over 50years of age showed that more number of patients on the drug halved the frequency of one night urination and decreased the number of nights with one or more trips to the bathroom.

The side effects of desmopressin to cause hyponatremia, requires that the manufacturer should put medication guide and boxed warning on the package.  Physician should always check the sodium level of the patient before and during therapy periodically.

Contraindicated is patients with hyponatremia, electrolyte imbalance, renal damage, symptomatic CCF, uncontrolled hypertension, pregnancy, gestational DM and patients on steroids and loop diuretics.

The full text of the FDA press announcement can be accessed here.

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[1] https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm544877.htm

ACOG issues a practice advisory on eating seafood during pregnancy and in lactating mothers.

courtesy: Pixabay

On January 19, 2017, FDA and EPA revised the guidelines for eating fish by women trying to conceive, pregnant, breast feeding or have young children to make informed choices about choosing the quantity and quality of fish.[i]

ACOG has affirmed the advice by FDA/EPA:[ii]

• It encourages wanting to be pregnant, pregnant ,lactating women and  mothers of very young children to eat 2-3 (8-12 ounces total) servings of fish per week from a variety of choices as shown in the chart.
• Only one serving of (no more than 6 ounces) some type of fish such as albacore (white) tuna or with similar mercury concentration.
• Totally avoid fish with high mercury concentration as shown in the chart.
• Be alert for fish caught by family and friends, as not much is known about some of these fish. If you eat that, you are done for the week, do not eat any other type of fish for the week.
• Avoid all raw or undercooked seafood, meat and eggs for the fear of getting listeriosis. Pregnant women are 20 times more likely to get listeriosis than healthy adults.

FDA  Fish Chart 

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[i] http://www.fda.gov/Food/FoodborneIllnessContaminants/Metals/ucm393070.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

[ii] http://www.acog.org/About-ACOG/News-Room/Practice-Advisories/ACOG-Practice-Advisory-Seafood-Consumption-During-Pregnancy

US- FDA gives clearance to new 5-year contraceptive device Kyleena.

US-FDA approved a new contraceptive device called Kyleena by Bayer Pharmaceuticals preventing pregnancy for 5 years. [1]

Kyleena belongs to the category of Long acting contraceptive device (LARC) and will be available in the market by prescription from October. The small, flexible, plastic IUD contains 19.5 mg of a progestin hormone levonorgestrel.

According to recent data the use of long-acting reversible contraception (LARCs) has increased nearly five-fold in the last decade.

 Kyleena or other   hormonal IUCD are marginally more effective than copper IUCD as they better control the blood flow.

After using Kyleena for some time, women are likely to experience fewer days of spotting and bleeding or may experience amenorrhea. Regular period resumes after removal of the device.

"Data show that the use of effective, long-acting birth control methods including intrauterine devices – or IUDs – have helped to reduce unintended pregnancies in the United States but we still have a long way to go," said Anita L. Nelson, M.D., Professor and Chair, Obstetrics and Gynecology at Western University of Health Sciences, Pomona, Calif on Bayer’s website. "Kyleena is highly effective at preventing pregnancy and may be an appropriate choice for women who want a low-dose, non-daily birth control method”. [2]

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[1] http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails

[2] http://www.bayer.us/en/article.php?id=123025

FDA evaluating the safety of oral fluconazole in pregnancy.

In the light of new evidence linking oral fluconazole to miscarriages the FDA is currently reviewing the safety of oral fluconazole as a vaginal yeast infection treatment in pregnancy. This review comes in the wake of Danish study published in JAMA which reports abnormalities at birth when  oral fluconazole is taken in higher dose of 400-800 mg/day.

It was a Nationwide register-based cohort study in Denmark from 1997-2013. From a cohort of 1,405, 663 pregnancies, 3315 women were exposed to oral fluconazole from 7 through 22 weeks’ gestation. About 147 experienced a spontaneous abortion compared with 563 among 13,246 unexposed matched women (HR 1.48).

The current FDA drug label states that data available from studies in people do not suggest an increased risk of problems during pregnancy or abnormalities in developing babies when women are exposed to a single 150 mg dose of oral fluconazole to treat vaginal yeast infections.

FDA cautions the healthcare professionals about the use of this drug until the review is complete. The agency has previously classified it as  pregnancy class D, meaning that there is evidence of risk to the fetus, but it may be used if the mother's condition is serious or life-threatening.

CDC guidelines also recommend only using topical antifungal products to treat pregnant women with vulvovaginal yeast infections, including for longer periods than usual if these infections persist or recur.

FDA is also urging people and researchers to report any untoward effects of the drug. It is also reviewing additional data related to the drug use in pregnancy.

In addition to its use as antifungal for vaginal yeast infection, it is also used to treat infection of mouth, and esophagus. fungal infection of the brain and spinal cord called cryptococcal meningitis.

References:

Mølgaard-Nielsen D, Svanström H, Melbye M, Hviid A, Pasternak B. Association Between Use of Oral Fluconazole During Pregnancy and Risk of Spontaneous Abortion and Stillbirth. JAMA. 2016;315(1):58-67. doi:10.1001/jama.2015.17844.

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm497656.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery