ACOG

Femasys Expands Commercial Management Team with Addition of Experienced New Hires

Retrieved on: 
Mardi, mai 7, 2024
FDA, Episcopal conference, American College, Woman, Infertility, Insemination, Health, ICSI, IVF, ACOG, Booth, IUI

With the addition of new team members to its commercial team in key strategic geographical locations, Femasys is poised to fully initiate its strategic initiatives and execute on its delivery of innovative, accessible options to impact women’s healthcare.

Key Points: 
  • With the addition of new team members to its commercial team in key strategic geographical locations, Femasys is poised to fully initiate its strategic initiatives and execute on its delivery of innovative, accessible options to impact women’s healthcare.
  • The newly appointed team brings together seasoned professionals with a wealth of commercial experience across various sectors of the healthcare industry.
  • Their collective expertise plays a pivotal role in driving Femasys' commercial efforts forward to realize the Company’s strategic vision, with initial emphasis on the Company’s infertility portfolio, led by the FemaSeed® product.
  • The 2024 ACOG meeting presents an ideal opportunity for Femasys to showcase the strength of its initial commercial team and its commitment to shaping the future of women's healthcare.

Bayer to unveil late-breaking data from Phase III OASIS 1 and 2 for elinzanetant in the treatment of vasomotor symptoms associated with menopause

Retrieved on: 
Mercredi, mai 8, 2024
Science, Women, Research, Pharmaceutical, Health, Baby, Maternity, Consumer, Clinical Trials, Episcopal conference, American College, Safety, Woman, ACOG, Endometrial hyperplasia, Treatment, Systematic review, Meta-analysis, IUS

Bayer will present detailed results from the pivotal Phase III studies OASIS 1 and 2, evaluating the efficacy and safety of the investigational compound elinzanetant versus placebo, at the upcoming American College of Obstetricians and Gynecologists (ACOG) Annual Clinical & Scientific Meeting.

Key Points: 
  • Bayer will present detailed results from the pivotal Phase III studies OASIS 1 and 2, evaluating the efficacy and safety of the investigational compound elinzanetant versus placebo, at the upcoming American College of Obstetricians and Gynecologists (ACOG) Annual Clinical & Scientific Meeting.
  • ACOG takes place from May 17 – 19, in San Francisco, CA, United States.
  • Additional presentations will feature new findings from Bayer’s intrauterine systems (IUS) and menopause product portfolio, as well as a scientific symposium session on the science behind menopause symptoms.
  • These presentations demonstrate Bayer’s long-standing commitment to advance women’s healthcare as the company works towards broadening treatment options for women.

Grady Receives Highest Maternal Care Verification from The Joint Commission

Retrieved on: 
Mercredi, mai 1, 2024
Consensus, Mortality, DNP, American College, Level, Verification, Woman, Joint Commission, ACOG, Certification, RN, MLC, Disease, Mother, MBA, OCC, Nursing

ATLANTA, May 1, 2024 /PRNewswire/ -- The Joint Commission's Maternal Levels of Care (MLC) Verification program, offered in collaboration with the American College of Obstetricians and Gynecologists (ACOG), has named Grady Health System as a Level IV maternal care verified facility.

Key Points: 
  • ATLANTA, May 1, 2024 /PRNewswire/ -- The Joint Commission's Maternal Levels of Care (MLC) Verification program, offered in collaboration with the American College of Obstetricians and Gynecologists (ACOG), has named Grady Health System as a Level IV maternal care verified facility.
  • As a Level IV facility, the highest designation, Grady demonstrated its on-site medical and surgical care for the most complex maternal conditions and critically ill pregnant women and fetuses throughout antepartum, intrapartum, and postpartum care.
  • "The Joint Commission commends Grady Health System for being named a Level IV maternal care verified facility and for its efforts to standardize maternal care and reduce maternal morbidity and mortality," says Ken Grubbs, DNP, MBA, RN, executive vice president of Accreditation and Certification Operations and chief nursing officer, The Joint Commission.
  • "The Maternal Levels of Care Verification program will help Grady strengthen regionalized care for mothers and babies in its community."

Natera Launches Fetal RhD NIPT Supporting Ob/Gyn Physicians and Patients During RhIg Shortage

Retrieved on: 
Mercredi, mai 1, 2024
Health, Consumer, Women, Genetics, Baby, Maternity, Clinical Trials, Biotechnology, Fetus, Nucleic acid thermodynamics, Gamma globulin, Episcopal conference, American College, NTRA, Laboratory, RHD (gene), Anemia, Risk, Pregnancy, Blood, Northwell Health, Quality, Genetic testing, Obstetrics, DNA, SNP, ACOG, ASHG, NIPT, Patient, Human genetics, Society, Physician, Antibody, Panorama, Dietary supplement

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA (cfDNA) and genetic testing, today announced the launch of a new cfDNA-based fetal RhD test.

Key Points: 
  • Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA (cfDNA) and genetic testing, today announced the launch of a new cfDNA-based fetal RhD test.
  • This comes at a critical time for the healthcare industry, helping physicians navigate patient care given nationwide shortages of Rho(D) immune globulin therapy (RhIg).
  • Natera’s test can be performed as early as nine weeks gestation and determines fetal RhD status from the blood of a pregnant patient, including complex pseudogene and RhD-CE-D hybrid variants.
  • The vast majority of other NIPT laboratories do not offer fetal RhD assessment, which makes it a key differentiator in addition to Natera’s core SNP-based technology.

Curio Digital Therapeutics Inc. Announces the U.S. Food and Drug Administration (FDA) Clearance of MamaLift Plus™, the First Prescription Digital Therapeutic Authorized for the Treatment of Postpartum Depression (PPD)

Retrieved on: 
Mardi, avril 23, 2024
Mental Health, Women, FDA, Baby, Maternity, Clinical Trials, Biotechnology, Health, Consumer, Pharmaceutical, American College, Regulation, PPD, Woman, Behavioral activation, Food, Cognitive behavioral therapy, BAT, Depression, DBT, Smartphone, Summer, ACOG, Therapy, Edinburgh Postnatal Depression Scale, Patient, MPH, Postpartum depression, Face, ITT, IPT, RCT, Dialectical behavior therapy, CBT, EPDS

Curio Digital Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has granted clearance to MamaLift PlusTM.

Key Points: 
  • Curio Digital Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has granted clearance to MamaLift PlusTM.
  • MamaLift Plus treats mild to moderate postpartum depression by improving a patient’s symptoms of depression.
  • MamaLift Plus delivers digital Cognitive Behavioral Therapy (CBT), Behavioral Activation Therapy (BAT), Interpersonal Therapy (IPT), and Dialectical Behavior Therapy (DBT) for postpartum depression.
  • The clearance of MamaLift Plus is based on results from the Supporting Maternal Mental Health and Emotional Regulation (SuMMER).

The Inner Circle acknowledges Jaleen D. Sims, MD, MPH, FACOG as a Pinnacle Lifetime Member

Retrieved on: 
Vendredi, mars 22, 2024
Well, Health, Organization, Birth, Gynaecology, Motivation, Public health, HOPE, Mentorship, Trust, FACOG, Patient, Knowledge, MSMA, University, MMSA, Woman, Wichita State University, American College, MPH, ACOG, Multimedia, Family, Physician, Inner circle, Medicine, Nursing

FLOWOOD, Miss., March 22, 2024 /PRNewswire/ -- Prominently featured in The Inner Circle, Jaleen D. Sims, MD, MPH, FACOG is acknowledged as a Pinnacle Lifetime Member for her contributions as a Leading Obstetrics and Gynecology Specialist.

Key Points: 
  • FLOWOOD, Miss., March 22, 2024 /PRNewswire/ -- Prominently featured in The Inner Circle, Jaleen D. Sims, MD, MPH, FACOG is acknowledged as a Pinnacle Lifetime Member for her contributions as a Leading Obstetrics and Gynecology Specialist.
  • Dr. Jaleen D. Sims, MD, MPH, FACOG, practicing board certified OB/GYN at Jackson-Hinds Comprehensive Health Center in Jackson, MS, is a leading figure in women's healthcare.
  • She is making waves in Mississippi with her expertise in normal and high-risk pregnancies, minimally invasive gynecological procedures, teen gynecology, contraception, and preventative cancer screenings.
  • Her dedication to advancing women's healthcare has earned her the trust and admiration of both patients and peers.

BayCare's St. Joseph's Women's Hospital Achieves Level IV Maternal Care Certification from The Joint Commission

Retrieved on: 
Jeudi, mars 21, 2024
Consensus, Mother, RN, Disease, Certification, Culture, Cone Health Women's Hospital, Level, Central Florida, Woman, Joint Commission, MLC, Mental, Partnership, Education, Verification, DNP, Patient, Mental health, Mortality, Anesthesiology, University, MBA, American College, OCC, Hospital, ACOG, Health, Nursing

TAMPA, Fla., March 21, 2024 /PRNewswire/ -- BayCare, the leading health care system in West Central Florida, today announced that St. Joseph's Women's Hospital has attained the highest level of certification in Maternal Care by The Joint Commission, the nation's oldest health care accrediting organization.

Key Points: 
  • TAMPA, Fla., March 21, 2024 /PRNewswire/ -- BayCare, the leading health care system in West Central Florida, today announced that St. Joseph's Women's Hospital has attained the highest level of certification in Maternal Care by The Joint Commission, the nation's oldest health care accrediting organization.
  • As a Level IV maternal care verified facility, St. Joseph's Women's Hospital is recognized for its commitment to providing exceptional maternal healthcare services.
  • "The Joint Commission commends St. Joseph's Women's Hospital for being named a Level IV maternal care verified facility and for its efforts to standardize maternal care and reduce maternal morbidity and mortality," says Ken Grubbs, DNP, MBA, RN, executive vice president of Accreditation and Certification Operations and chief nursing officer, The Joint Commission.
  • "The Maternal Levels of Care Verification program will help St. Joseph's Women's Hospital strengthen regionalized care for mothers and babies in its community."

Cepheid Receives FDA Clearance for Xpert® Xpress GBS

Retrieved on: 
Lundi, mars 11, 2024
PCR, Obstetrics, Streptococcus, Rheumatic fever, EVP, INT, Risk, Cepheid variable, Antibiotic prophylaxis, Antimicrobial stewardship, Fungal infection, Genome, Woman, American College, GBS, Negative, ACOG, Infant, Food, Sintering

SUNNYVALE, Calif., March 11, 2024 /PRNewswire/ -- Cepheid announced today that it has received clearance from the U.S. Food and Drug Administration for Xpert® Xpress GBS, a dual-target molecular diagnostic test for the qualitative intrapartum detection of Group B Streptococcus (GBS). This next-generation test incorporates new dual targets in highly-conserved regions of the GBS genome to improve sensitivity and bacterial strain coverage. The test is designed for use on Cepheid's GeneXpert® systems.

Key Points: 
  • SUNNYVALE, Calif., March 11, 2024 /PRNewswire/ -- Cepheid announced today that it has received clearance from the U.S. Food and Drug Administration for Xpert® Xpress GBS, a dual-target molecular diagnostic test for the qualitative intrapartum detection of Group B Streptococcus (GBS).
  • Xpert Xpress GBS allows for the use of intrapartum direct PCR testing for women with unknown or unavailable antepartum GBS status.
  • With the capability of returning positive results as early as 30 minutes,2 Xpert Xpress GBS can provide real-time GBS status and inform decisions about empiric antibiotic prophylaxis if appropriate, to prevent GBS transmission during birth.
  • With Xpert Xpress GBS, Cepheid continues to provide fast, accurate, and reliable PCR solutions to facilitate evidence-based treatment and improved clinical care.

Igentify Launches New NIPT and Pharmacogenomics Offerings

Retrieved on: 
Mardi, mars 5, 2024
Technology, Science, Family, Genetics, Consumer, Clinical Trials, Biotechnology, Health, Health Technology, Apps, Applications, Research, Software, Other Health, Internet, Parenting, Pharmaceutical, Baby, Maternity, ACOG, NIPT, ECS, Workflow

Igentify , a digital health company alleviating bottlenecks in the genetic testing process, announced the launch of its Non-Invasive Prenatal Testing (NIPT) and Pharmacogenomics (PGx) offerings via the Digital Genetic Assistant platform.

Key Points: 
  • Igentify , a digital health company alleviating bottlenecks in the genetic testing process, announced the launch of its Non-Invasive Prenatal Testing (NIPT) and Pharmacogenomics (PGx) offerings via the Digital Genetic Assistant platform.
  • This new roll-out comes in addition to their Expanded Carrier Screening (ECS) offering.
  • The NIPT workflow includes a patient web-app that facilitates all aspects of patient intake, including an ACOG-compliant consenting process using Igentify’s proprietary video technology to create highly personalized educational videos for each patient.
  • “We are thrilled to expand the accessibility of our platform with programs focused on non-invasive prenatal testing and pharmacogenomics,” said Elliott Greenspan, Chief Innovation Officer and Co-founder of Igentify.

Alpha Cognition Files U.S. Patent Application Covering an ALPHA-1062 Oral Formulation to Treat Mild to Moderate Alzheimer’s Disease

Retrieved on: 
Jeudi, février 22, 2024
Research, Patent Law, Neurology, FDA, Professional Services, Biotechnology, General Health, Pharmaceutical, Health, Science, Therapy, ACOG, Clinical trial, File, Patent, ACI, Patient

The present composition-of-matter patent application is filed for approval with the USPTO and may be extended to pursue protection throughout the world and, if approved, will secure composition-of-matter protection for an oral formulation of ALPHA-1062.

Key Points: 
  • The present composition-of-matter patent application is filed for approval with the USPTO and may be extended to pursue protection throughout the world and, if approved, will secure composition-of-matter protection for an oral formulation of ALPHA-1062.
  • The filing was based on novel and unexpected findings in the clinical trial work the company completed and further demonstrates the uniqueness of ALPHA-1062.
  • If approved, the patent will provide protection for ALPHA-1062 into 2044, adding to other patent protection that currently protect ALPHA-1062 through 2042.
  • “Filing this patent application is an important component of our strategy to ensure broad protection for ALPHA-1062, a next generation treatment option for patients suffering from mild-to-moderate Alzheimer’s Disease.