Monday, December 31, 2018

FDA clears first ever test to analyze the nutrients in Human Breast Milk


The U.S. Food and Drug Administration recently permitted marketing of a diagnostic test that analyzes nutrients in breast milk. The test will help healthcare providers in managing the specific nutritional needs of newborns and young infants at risk for growth failure due to prematurity or other medical conditions.

Developed and marketed by a Swedish company Miris, the Miris HMA - Human Milk Analyzer reports the fats, carbohydrates, proteins, and energy content of the milk within 60 seconds using 1-3 cc of the milk. 

“For the first time, doctors have access to a test to help analyze the nutrients in breast milk. While this test is not for everyone, it has the potential to aid parents and healthcare providers, mainly in a hospital setting, in better assessing the nutrient needs of certain babies who are not growing as expected,” said Courtney Lias, Ph.D. director of the Division of Chemistry and Toxicology Devices in the FDA’s Center for Devices and Radiological Health in a press release.

“Breast milk provides many health benefits to infants, and for many babies, it can meet their early nutritional needs. But some infants — including those who may be born preterm or have certain health conditions — may need additional nutrients in order to support their optimal growth,” she further added.

“Knowing the macronutrient content of the breast milk may help the health care team and parents make informed decisions on how to fortify the breast milk based on the individual needs of the infant,” explains FDA in the recent press release.

The Miris Human Milk Analyzer can be purchased only through prescription and is for use by trained personnel at clinical laboratories. The device uses approved Infrared transmission spectroscopy to analyze accurately the total solids and energy content contained in the milk along with quantitative measurement of fat, protein and total carbohydrate in a single run.

The device does not use any chemicals and is small, portable and easy to use. The results can be easily transferred to a computer.

The FDA reviewed the Miris Human Milk Analyzer test through the De Novo premarket review pathway and clearance was based on comparable results obtained by analysis of 112 samples of human milk tested by the Miris analyzer and by independent methods. Both methods were equally effective at determining levels of protein, fat, and carbohydrates in the milk.

Certain conditions may limit the ability of the test to accurately determine the milk content like some medications taken by a nursing mother. FDA advises the healthcare provider to use the test results of Miris Human Milk Analyzer along with clinical parameters of the baby in formulating the nutritional plan for the infant and in informed decision making.

FDA has also put in place specific criteria called “special controls” to ensure the accuracy and reliability of the test results and to aid in the nutritional management of certain infants. These “special controls” along with general control helps maintain the specificity and accuracy of this type of tests.

Here is a short overview of how the Miris HMA - Human Milk Analyzer works.





Sunday, December 30, 2018

Here are the top 5 most read ultrasound posts of 2018



With only a few hours left for the calendar year 2018 to come to an end, take a look at the top 5 most read ultrasound posts of the year as we gear up to look forward to another year of medical advances and health research. 


Blob and Bagel sign on Ultrasound can be labeled as definitive for Ectopic Pregnancy
Women with the Blob and Bagel ultrasound sign should be reclassified from having ‘probable’ ectopic pregnancy (EP) to ‘definitive’ EP and should be treated as such reports the result of a large retrospective cohort study published March 11, 2018, in Journal of Ultrasound in Obstetrics and Gynecology.
Ectopic Pregnancy is still the leading cause of first-trimester maternal deaths and constitutes 4% of all pregnancy-related deaths. The incidence of ectopic is highest in women undergoing In-Vitro Fertilization (IVF) and ranges from 4% to 11% of all pregnancies.

Novel cross-over sign in cesarean scar pregnancy helps predicts the risk of invasive placentation
First trimester ultrasound scan evaluating the relationship between the gestational sac and the endometrial line in women with cesarean scar pregnancy(CSP) helps predicts the development of abnormally invasive placenta (AIP) and consecutive intra and post-operative surgical morbidities reports the results of a retrospective case series published in the Journal of International Society of Ultrasound in Obstetrics and Gynecology.

Recent advances in prenatal imaging and increase rate of cesarean sections have led to increased diagnosis of CSP. Although, most of the patients with CSP present with severe hemorrhage or rupture uterus, that requires emergency surgical management, few advances further, evolving into AIP. 

Negative sliding sign by ultrasound in repeat cesarean section predicts the presence of severe intrabdominal adhesions
A negative sliding sign by ultrasonography (USG) in patients with previous cesarean section helps alert the surgeon to expect massive intraabdominal adhesions, difficult repeat cesarean section and need of blood transfusion during surgery reports the results of a prospective observational study published ahead of print in the February issue of Journal Obstetrics and Gynecology.

Postoperative adhesion formation is quite prevalent after an abdominal or pelvic surgery and any method which can predict the existence of such adhesion could optimize the outcome of current surgery.

GE Healthcare introduces its new automated breast ultrasound for dense breast
There could not have been a more appropriate time for the launch of GE Healthcare new Invenia Automated Breast Ultrasound (ABUS) 2.0 than October, which is celebrated as breast cancer awareness month. The Invenia ABUS is the only FDA approved 3D ultrasound system for supplemental screening for breast cancer along with mammography.

In conjunction with mammography, it increases the chances of cancer detection in the dense breast by 55%. All breasts are not the same, the density of breast is determined by a proportion of fat and breast tissue—when the percentage of breast tissue exceeds that of fat, breasts are labeled as being dense.

A practical guide to count ovarian antral follicles by ultrasound
A consensus opinion highlighting the main techniques of ovarian antral follicle count (AFC), and providing recommendations for future research is published in the special issue on Reproductive Medicine of the journal Ultrasound in Obstetrics and Gynecology.

The consensus makes several recommendations for varied methods used in counting the antral follicles, but no single method is superior over others and the choice should make the best use of resources available in a setting.


Here are the top 10 most read posts of 2018



With only a few hours left for the calendar year 2018 to come to an end, take a look at the top 10 most read posts of the year as we gear up to look forward to another year of medical advances and health research. 

ACOG guidance on prevention of surgical-site infection in gynecologic surgery
Surgical site infections (SSIs) after gynecological surgery is a significant cause of postoperative morbidity leading to repeated hospital visits.  These infections also incur heavy social and economic burden on patients and the healthcare system.
The recent ACOG practice bulletin is published in the June issue of Journal of Obstetrics and Gynecology and replaces Practice Bulletin Number 104, May 2009, and Committee Opinion Number 571, September 2013.

New approach to ovarian cystectomy: Transvaginal natural orifice transluminal endoscopic surgery
Natural orifice transluminal endoscopic surgery (NOTES) is a challenging minimally invasive procedure where ‘scarless’ abdominal surgeries are performed through an endoscope inserted through a natural orifice (mouth, anus, vagina, and urethra) and is considered as a less invasive approach to laparoscopic surgeries. 

NOTES is considered a logical next step in the evolution of minimally invasive surgery, and the first NOTES procedure in humans is often considered to be a transgastric appendectomy performed in India in 2006 which was presented but not reported in manuscript form.

Blob and Bagel sign on Ultrasound can be labeled as definitive for Ectopic Pregnancy
Women with the Blob and Bagel ultrasound sign should be reclassified from having ‘probable’ ectopic pregnancy (EP) to ‘definitive’ EP and should be treated as such reports the result of a large retrospective cohort study published March 11, 2018, in Journal of Ultrasound in Obstetrics and Gynecology.
Ectopic Pregnancy is still the leading cause of first-trimester maternal deaths and constitutes 4% of all pregnancy-related deaths. The incidence of ectopic is highest in women undergoing In-Vitro Fertilization (IVF) and ranges from 4% to 11% of all pregnancies.


Novel cross-over sign in cesarean scar pregnancy helps predicts the risk of invasive placentation
First trimester ultrasound scan evaluating the relationship between the gestational sac and the endometrial line in women with cesarean scar pregnancy(CSP) helps predicts the development of abnormally invasive placenta (AIP) and consecutive intra and post-operative surgical morbidities reports the results of a retrospective case series published in the Journal of International Society of Ultrasound in Obstetrics and Gynecology.

Recent advances in prenatal imaging and increase rate of cesarean sections have led to increased diagnosis of CSP. Although, most of the patients with CSP present with severe hemorrhage or rupture uterus, that requires emergency surgical management, few advances further, evolving into AIP. 


Negative sliding sign by ultrasound in repeat cesarean section predicts the presence of severe intrabdominal adhesions
A negative sliding sign by ultrasonography (USG) in patients with previous cesarean section helps alert the surgeon to expect massive intraabdominal adhesions, difficult repeat cesarean section and need of blood transfusion during surgery reports the results of a prospective observational study published ahead of print in the February issue of Journal Obstetrics and Gynecology.
Postoperative adhesion formation is quite prevalent after an abdominal or pelvic surgery and any method which can predict the existence of such adhesion could optimize the outcome of current surgery.

GE Healthcare introduces its new automated breast ultrasound for dense breast
There could not have been a more appropriate time for the launch of GE Healthcare new Invenia Automated Breast Ultrasound (ABUS) 2.0 than October, which is celebrated as breast cancer awareness month. The Invenia ABUS is the only FDA approved 3D ultrasound system for supplemental screening for breast cancer along with mammography.
In conjunction with mammography, it increases the chances of cancer detection in the dense breast by 55%. All breasts are not the same, the density of breast is determined by a proportion of fat and breast tissue—when the percentage of breast tissue exceeds that of fat, breasts are labeled as being dense.

A practical guide to count ovarian antral follicles by ultrasound
A consensus opinion highlighting the main techniques of ovarian antral follicle count (AFC), and providing recommendations for future research is published in the special issue on Reproductive Medicine of the journal Ultrasound in Obstetrics and Gynecology.
The consensus makes several recommendations for varied methods used in counting the antral follicles, but no single method is superior over others and the choice should make the best use of resources available in a setting.

ACOG update: Letrozole is the first line therapy for ovulation induction in PCOS
The American College of Obstetricians and Gynecologists (ACOG) now recommends Letrozole (aromatase inhibitor) as the first-line treatment for ovulation induction in women with Polycystic Ovarian Syndrome (PCOS) due to data demonstrating increased ovulation rates, clinical pregnancy rates and live-birth rate vs clomiphene citrate. The guidelines are published as Practice Bulletin No. 194 in the June issue of Journal Obstetrics and Gynecology.
This replaces the Practice Bulletin Number 108, published October 2009, which recommends letrozole as first-line therapy for ovulation induction only in women with PCOS and a BMI greater than 30.

Sonographically measured fetal head circumference ≥35 cm at term increases the odds of cesarean delivery
Sonographically measured fetal head circumference ≥35 cm, within a week of delivery increases the odds of unplanned cesarean section by 75% report the results of multicenter observational study accepted for publication in American Journal of Obstetrics and Gynecology.

Currently, In the US, one in every third baby is born by cesarean section and the high rate is a cause of concern for the healthcare industry.

FDA approves a bedside test for assessing the risk of spontaneous preterm birth
QIAGEN won FDA approval for marketing its Novel PartoSure® point of care test for estimating the risk of spontaneous preterm birth in patients who present with symptoms of preterm labor. PartoSure represents a breakthrough in research and development of diagnostic tests for preterm birth.

Predicting preterm birth is a diagnostic challenge and nearly 85% of patients admitted to the hospital for threatened preterm labor (PTL) do not deliver within the next 7 days, resulting in unnecessary interventions.