News & Events

US Food and Drug Administration FDA clearance

FlowAid has received U.S. Food and Drug Administration FDA clearance for its FA100 SCCD (Sequential Continuous Contraction Device) for the following indications: increase of local blood circulation, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, prevention or retardation of disuse atrophy and edema reduction. The FA100 SCCD is the first device of its kind cleared by the FDA for the indication of edema reduction.

Additional FDA applications will be submitted to expand our claims for other disease-specific indications, including the treatment of Diabetic Peripheral Neuropathy and Lymphedema.

 

 

 

Positive Results from a Study of Patients with Diabetic Peripheral Neuropathy

A New Look at a Therapeutic Treatment for Diabetic Peripheral Neuropathy (DPN)

segments from the Press Release:
FlowAid Medical Technologies Corp. announced positive results from a study of the usage of its FA100 Sequential Contraction Compression Device among a group of patients with diabetic peripheral neuropathy. Following 30 days of supervised home use, the patients reported significantly less pain, less reliance on analgesics and fewer nights of disturbed sleep.

FlowAid CEO Jacob Brezel: “The new research could alter the way Diabetic Neuropathy is understood and treated. Use of the FA100 SCCD on patients suffering from hypoesthetic DPN restores sensation. We are planning larger studies that will bear out our findings”

Based on the study “Sequential Contraction Compression Device Therapy affects Symptomatic Diabetic Peripheral Neuropathy”, published in the Journal of Diabetic Complications & Medicine accessible on our Clinical webpage

Health Canada Medical Device License Issued

The Health Canada Medical Device License was issued on 18 August 2016 for the FA100 SCCD just four weeks after receiving the European Union CE Mark

UK – Multi-center Study Using the FA100 SCCD

A multi-center study using the FA100 SCCD has started in several major NHS hospitals and clinics in Southampton, UK and in Portsmouth, UK.

 

Dr Graham Bowen, Head of Podiatry & Clinical Services Manager at Solent NHS Trust trying out the FA100 SCCD with CEO Jacob Brezel

Dr Graham Bowen, Head of Podiatry & Clinical Services Manager at Solent NHS Trust trying out the FA100 SCCD with CEO Jacob Brezel

 

In other UK news:

John Bell & Croyden Pharmacists and online store have expressed strong interest in the FA100 SCCD and said they want it on their shelf. The history of John Bell & Croyden goes back to the beginning of the pharmacist profession in the United Kingdom. They hold accreditation of Royal Warrant as Pharmacists to Her Majesty Queen Elizabeth II. Product will be available by early September.

CE Mark & ISO Certification for FlowAid FA100 SCCD

We are happy to announce that we received the CE Mark for the FA100 SCCD in Europe. We also received ISO 13485 certification for our Quality Management System (QMS) in accordance with EU requirements and the Canadian Medical Device Conformity Assessment System (CMDCAS).
Click here to view certifications

UAE – Multi-center Study Using the FA100 SCCD

Evaluations of the FA100 SCCD are in process by a diabetologist in a Private Hospital in Sharjah, by a vascular surgery team in Dubai Hospital, and by a podiatrist at The Dubai Diabetes Center.

India – Study Using the FA100 SCCD

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Another study will be taking place at the Kerala Institute of Medical Science (KIM) in Anayara, Thiruvananthapuram District, Kerala, India.

Singapore – Multi-center Study Using the FA100 SCCD

Dr.  Jonathan Rosenblum, of our Scientific Advisory Board, met with heads of departments, surgeons and clinicians in Singapore General Hospital, Tan Tock Seng Hospital, Changi General Hospital, National University Hospital and St. Luke’s Hospital.

Overwhelming interest in the FlowAid FA100 SCCD at the FIP World Congress of Podiatry in Montreal

We presented our device before a large audience at the FIP World Congress of Podiatry in Montreal on May 26th 2016. There was overwhelming interest in the FlowAid FA100 SCCD. “A Technology for Treating Circulatory Disorders of the Lower Extremities” was presented by Dr Jonathan Rosenblum. Watch his presentation below:

We are pleased to announce the new additions to our Scientific Advisory Board:

Prof. Marco Romanelli is a Board certified, Consultant Dermatologist at the Department of Dermatology, University of Pisa, Italy

Prof. Luc Téot is Associate Professor of Plastic Surgery in Wound Healing and Burns at Montpellier University Hospital France

Dr. Michael S. Miller is the Assistant Professor of Surgery Des Moines University Osteopathic Medical Center Des Moines, IA.  Dr. Miller is the Medical Director at The Wound Healing Centers Bedford, IN: Linton, IN: Terre Haute, in USA.

Dr. Jeremy Tamir MD is the Director of the Wound Care Center, and Plastic Surgery Clinic of Halstead Hospital Kansas, USA.

Dr. Jonathan Rosenblum serves as an Adjunct Clinical Instructor at the Dept. of Medicine in NY College of Podiatric Medicine, New York USA

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