Sense4Baby Receives 510(k) Clearance, CE Mark

Sense4Baby Inc. has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and a CE mark from the European Commission to commercialize its maternal/fetal heart rate monitoring device.
The Sense4Baby System allows healthcare practitioners in the U.S. and Europe to monitor mothers and their fetuses in the third trimester of pregnancy using a cellular device anywhere wireless access is found.

Does ‘Low T’ Treatment Bring High Heart Attack Risk?

For older men who suspect their flagging energy and sex drive might be due to low testosterone, or low T, as commercials and advertisements call it, getting a prescription for testosterone gel seems to be an easy way to put the spring back in their step.

In fact, the gel (brand name AndroGel) has become so popular (and so heavily marketed), it’s even outselling Viagra.

Unfortunately, recent research — including a large new study published this week — links the hormone therapy with a significantly higher risk of a heart attack.

Commitment posters encourage antibiotic stewardship

By Megan Brooks

NEW YORK (Reuters Health) – Hanging a poster in exam rooms displaying a doctor’s picture and commitment not to prescribe antibiotics for likely viral illness cut inappropriate prescribing during an influenza season in a randomized controlled trial.

“One of the advantages of this approach is that it is relatively easy to implement and administer in comparison to other clinical quality improvement programs,” Dr. Daniella Meeker of RAND Corporation in Santa Monica, California, who worked on the study, told Reuters Health in an email.

Valiant Captivia Thoracic Stent Graft System From Medtronic Receives FDA Approval for Treating Aortic Dissections

Continuing to expand the role of endovascular aortic repair, Medtronic, Inc. (NYSE: MDT) has received approval from the U.S. Food and Drug Administration (FDA) for the Valiant Captivia Thoracic Stent Graft System to be used in the treatment of type B aortic dissections, a serious cardiovascular condition associated with high morbidity and mortality in which the upper segment of the body’s main artery has become torn along the innermost layer of the vessel wall.

Weight loss, nutritional programs, exercise, and proper weight / Breast cancer recurrence and physical activity

A recent study in the medical journal Breast Cancer sought to answer the apparent contradictions in research that support weight loss, nutritional programs, exercise, and proper weight as the primary beneficial cause of reduction of breast cancer recurrence.

LA BioMed Physician-Researchers Recognized As the Nation’s and the Region’s Best Doctors Honorees Demonstrate Dedication to Advancing Innovation and Improving Medical Care

Forty-two of Los Angeles Biomedical Research Institute’s (LA BioMed’s) physician-researchers will be ranked among America’s Top Doctors when it issues its 2014 publication later this year or they are listed among theSouthern California Super Doctors for 2014 in the January edition of Los Angeles Magazine.

Emmaus Medical Announces Completion Of All Patient Visits For Its Phase 3 Clinical Trial For Treatment Of Sickle Cell Disease

Emmaus Medical, Inc. (the “Company,” or “Emmaus”), a biopharmaceutical company engaged in the discovery, development and commercialization of innovative and cost-effective treatments and therapies primarily for rare and orphan diseases, today announced it has completed all patient visits for its Phase 3 clinical trial for the treatment of sickle cell disease. Emmaus expects top-line data from the Phase 3 clinical trial to be available in the first quarter of 2014.

Antibiotics Best, But Not Only Way to Treat Recurrent UTIs

Daily antibiotic use came out on top when compared with several other strategies for managing recurrent urinary tract infections (UTIs), but daily cranberry pills, daily estrogen therapy, and acupuncture also had good showings of cost-effectiveness.

Increasing Exercise Tolerance in COPD Patients with Ambulatory Ventilation

A new ambulatory noninvasive ventilation device is proving effective at increasing exercise tolerance for patients with COPD, an important factor for improving patient outcomes and quality of life.

For many COPD patients, a simple walk from one room to the next can be exhausting. For respiratory therapists and pulmonary physicians, improving the exercise tolerance of COPD patients is key to improving their lives, since a chief complaint is often their inability to participate in everyday activities.

Clarus Therapeutics Submits New Drug Application for Rextoro (formerly CLR-610) for the treatment of Low Testosterone

Clarus Therapeutics, Inc., today announced the submission of a New
Drug Application (NDA) for Rextoro™ (formerly CLR-610), the
Company’s oral testosterone (T) replacement product, to the
U.S. Food and Drug Administration (FDA).  Efficacy consistent
with the current FDA mandate for T-replacement products was
achieved in two Phase 3 studies.  After protocol-prescribed
dose titration, at least 75% of men treated with Rextoro achieved
average serum T levels (C‑avg) in the normal range (between 300 –
1,000 ng/dL).