FDA approves pelvic floor trainer for OTC sales

Analytica announced that the U.S. Food and Drug Administration (FDA) has approved the PeriCoach® at-home pelvic floor trainer device and smartphone app as an over-the-counter (OTC) treatment for treatment of mild, moderate and stress urinary incontinence (UI) and urge incontinence. A strong pelvic floor is also associated with improved sexual function and satisfaction.


“Women can use pelvic floor exercises or “Kegels” to reduce or eliminate symptoms, and home training with PeriCoach, now available OTC, just got a lot more convenient,” said Leslie Rickey, MPH, MD, Associate Professor of Urology and of Obstetrics, Gynecology and Reproductive Sciences; Fellowship Director, Female Pelvic Medicine and Reconstructive Surgery, Yale School of Medicine. “It is critical that women put their trust in new technology for pelvic floor muscle training that has been medically tested and FDA-cleared, as these products have an internal component and are designed to treat a real medical condition.”

Pelvic floor muscle exercise (PFME) is recommended as first line non-pharmacologic treatment for the millions of women–estimated at one in three--who suffer from urinary incontinence.

Since its introduction in 2015 as a prescription product, PeriCoach, designed by a woman engineer, has been studied and clinically evaluated by clinicians including women’s health physical therapists, urogynecologists, OBGYNs and urogynecological nurses. Data and case reports have been presented and published in peer-reviewed forums.

“As a physical therapist, I feel confident recommending to my patients, and using on myself, vaginal devices that were developed and evaluated first as medical products,” said Heather Jeffcoat, DPT, founder of Fusion Wellness & Physical Therapy and author of Sex Without Pain: A Self-Treatment Guide To The Sex Life You Deserve. “PeriCoach has a well-established profile as an easy-to-use, effective and affordable home pelvic floor trainer. Now, for women who will benefit from PFME, there are no more excuses!”

UI has both lifestyle and financial costs. For example:
• One in three women will experience UI at some point in their lives
• Half of the women who suffer from UI don’t report it and try to manage the condition on their own for 6 years or more before speaking to a clinician
• In the USA alone, adults spend over $20 billion dollars on “routine care” of UI including pads, protection and laundry
• The cost of pads for one woman in the USA for one year is approximately $900

“This approval will bring PeriCoach, and the confidence that comes with it, to women in a convenient way,” said Geoff Daly, CEO Analytica, LTD. “The OTC approval is also a significant milestone for our company in the U.S. We are committed to offering as many women as possible a simple, effective way to deal with a condition that is common but not normal. Over the counter availability of PeriCoach may mean the difference between a day lost to worrying about leaking, and a day confident in enjoying favorite activities.”

More details can be found from http://www.pericoach.com 

Bausch Lomb & IBM to work on cataract surgery APP on IBM Cloud

Bausch + Lomb announced a collaboration to develop the first app of its kind for iPhone and iPad for surgeons who perform cataract surgery. The innovative app will help surgeons streamline their workflow by delivering patient information and clinical insights as well as intraocular lens (IOL) options on a single, digital platform at the point of care.

than 22 million Americans and that number is expected to rise to 30 million by 2020 . Cataracts – a clouding of the eye’s lens that can lead to blindness if untreated – affect approximately 70 percent of people by age 75 . In cataract surgery, the cloudy lens is removed and replaced with an artificial lens – an IOL.

Today, many cataract surgeons consult patient data in the operating room (OR) via print-outs or notes created during pre-op patient office visits, which can often be bothersome and inefficient. The new app from Bausch + Lomb will be designed to provide surgeons with access to information that

patients have agreed to share, enabling doctors to plan their surgical interventions -- including IOL selection -- and have the option to view the information on digital devices or display screens on walls in the operating room during surgery.

The app will be designed to electronically manage patient data across iPhone and iPad while hosting health-related data on IBM Cloud Platform, Bluemix -- a security rich, cloud-based environment -- and relaying customized IOL options to surgeons that they will use to help enhance surgical

planning and provide better patient care. The MobileFirst for iOS team, which is part of IBM Global Business Services, will design and develop this custom app for Bausch + Lomb to help drive innovation in healthcare. Bausch + Lomb’s vision is to optimize the app to collect data over time, resulting in a cognitive app that applies machine-based learning and predictive analytics to deliver real-time insights to surgeons.

By compiling each cataract patient’s information in the app -- including IOL calculations, corneal topography and other biometry results as well as lifestyle preferences -- surgeons and their staff may generate a comprehensive, integrated profile to help them facilitate IOL selection and procedure

planning. Historical surgical data and other patient insights can also be housed within the app to potentially support positive clinical outcomes for future cataract.

A press release can be found following this link.

Shanghai builds 'Cloud Hospital' to fight chronical diseases

In order to serve increasing number of chronical disease patients, Shanghai City tries to build ‘Cloud Hospital’to bring conveniences and improve efficiency of treating patients.

The so called ‘Cloud Hospital’consists of Zhongshan Hospital Affiliated to Fudan University, Central Hospital of Xuhui District and 13 society clinics. Patients with chronical diseases can download an APP, through which patient file can be synchronized between society clinics and Zhongshan Hospital, or patients can consult doctors online by video chat, make appointments with doctors, and society clinics can also transfer patients to hospitals by using the same APP.

This ‘Cloud Hospital’had treated 160.000 patient/time since its kick off in August 2016.

2016 Chinese M-Health market preview

In the first 3 quarters of 2015, the Chinese m-Health cluster secured ca. $1.1 billion investment, though almost no new products or services were launched other than peripheral products like smart phone APPs, online patient-doctor appointment system, online consulting platform. Wearable device was one of the most discussed topics in 2015.

In 2016, new capitals are still rush entering the Chinese m-Health market, which will turn into one of the driving factors of market boosting. It is estimated that about 85% of m-Health products will be smart phone related, some market players tend to develop online-offline business models, but profitability is a challenge to everyone.

When m-Health first merged in Chinese market, it was regarded as a high-end service for some minorities, but the situation changed drastically as long as more and more patients starts to own a hardware like arm band, glucose meter with blue tooth, or blood pressure monitor with WiFi, or an APP on either iPhone or an Android phone or tablet.

M-Health is so far not efficiently supported by medical insurance system, which could be one of the bottle necks in the Chinese market. Once there are products or services supported by medical insurance, m-Health industry could be a new gold mine in China.