Success Stories


Here you can find our clients' success stories. We are happy to celebrate our client's accomplishments; successful regulatory submissions, funding publications and more. The largest source of pride comes from the achievements we've helped our clients reach. We've collected some noteworthy client information (from publicly available resources), and we're happy to introduce them here.

FDA Clears ConTIPI Medical’s Pelvic Prolapse Treatment

The FDA cleared ConTIPI Medical’s ProVate, a device used to temporarily manage pelvic organ prolapse in women without surgery.

The device consists of a vaginal ring pessary with a throwaway applicator. It can be removed by pulling a string, much like a tampon, and can be used for up to a week.

ProVate can be inserted and removed by the patient at home after initial training and size fitting by a medical practitioner.

https://www.fdanews.com/articles/191951-fda-clears-contipi-medicals-pelvic-prolapse-treatment

 


FDA Grants Theranica De Novo to Market First Smartphone-controlled Acute Migraine-relief Wearable Device

Clinical Data Show 66.7% Pain Relief Response Within Two Hours

NETANYA, Israel, May 28, 2019 /PRNewswire/ -- Theranica, a bio-medical technology company developing advanced electroceuticals for migraine and other pain disorders, announced today that the U.S. Food and Drug Administration (FDA) granted a De Novo request for its smartphone-controlled electroceutical, Nerivio Migra®, utilizing Remote Electrical Neuromodulation for the acute treatment of migraine.

"The clinical data of this innovative therapeutic device is of very high quality," commented Professor Messoud Ashina, Danish Headache Center, president-elect of the International Headache Society. "It indicates that the device can provide patients with significant relief of pain and other migraine symptoms without the side effects presented by drugs."

The FDA market authorization is based on the results of a prospective, randomized, double-blind, placebo-controlled, multi-center pivotal study, where 252 patients from 12 clinics used the non-invasive wearable to treat their migraine attacks.

Nerivio Migra®, a first-in-category product, is placed on the upper arm (not the head or neck) and uses smartphone-controlled electronic pulses to create a Conditioned Pain Modulation (CPM) response. Nerivio Migra® is indicated for acute treatment of migraine with or without aura in adult patients who do not have chronic migraine.

"While the company is preparing to launch the Nerivio Migra® in the United States market later this year at an affordable price, we remain committed to continuing our clinical development, expanding the use of remote electrical neuromodulation therapy for additional indications," said Alon Ironi, CEO and co-founder of Theranica. "We have identified at least 7 different painful conditions that may be relieved by this non-invasive, drug-free technology after appropriate clinical development."

https://www.prnewswire.com/news-releases/fda-grants-theranica-de-novo-to-market-first-smartphone-controlled--acute-migraine-relief-wearable-device-300857281.html?tc=eml_cleartime

BrainsWay Receives PMDA Approval in Japan of Deep Transcranial Magnetic Stimulation System for Treatment of Major Depressive Disorder

Approval allows BrainsWay’s Deep TMS System to be marketed throughout Japan

JERUSALEM, Jan. 29, 2019 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (TASE: BRIN), a global leader in the advanced non-invasive treatment of brain disorders, today announced that its Deep TMS System has been approved in Japan by the Pharmaceuticals and Medical Devices Agency (PMDA) for the treatment of patients suffering from Major Depressive Disorder (MDD) who did not benefit from previous antidepressants. The PMDA approval was obtained in collaboration with BrainsWay’s exclusive distributor in Japan, Century Medical, Inc. (CMI), an ITOCHU Group company. According to the World Health Organization, an estimated 5 million people suffer from depressive disorders in Japan.

“This PMDA approval represents a significant milestone in our efforts to expand our existing commercial footprint globally for BrainsWay Deep TMS,” said Yaacov Michlin, president and chief executive officer of BrainsWay. “Japan represents a significant market opportunity for BrainsWay and we look forward to providing our unique therapeutic solution to the many patients suffering from MDD throughout the country.”

The PMDA is the agency responsible for regulation of pharmaceuticals and medical equipment into Japan, and this approval was required to begin marketing BrainsWay Deep TMS in Japan. Additionally, PMDA approval is a precondition to receiving reimbursement coverage under the Japanese National Health Insurance Plan. CMI is working with relevant bodies in Japan in an effort to ensure that appropriate coverage of Deep TMS in Japan is ultimately achieved.

Takahiko Motani, president and CEO of CMI, stated, “We’re pleased to have secured this important approval. We expect that with this leading technology we will be able to significantly help Japanese patients who suffer from depressive disorders.”

https://globenewswire.com/news-release/2019/01/29/1706814/0/en/BrainsWay-Receives-PMDA-Approval-in-Japan-of-Deep-Transcranial-Magnetic-Stimulation-System-for-Treatment-of-Major-Depressive-Disorder.html

HemoScreen™ Hematology Analyzer For Point Of Care, Receives FDA 510(K) Clearance

YOKNEAM, Israel, Nov. 7, 2018 -- PixCell Medical announced today that The HemoScreen™ Hematology Analyzer received FDA 510(k) clearance, enabling commercialization in the USA.

The HemoScreen™ is a miniature portable hematology analyzer that uses disposable cartridges; each cartridge includes all necessary reagents and is designed to accept a drop of blood taken from the finger. The operation of the device is exceptionally simple and requires minimal training or expertise. Once the cartridge is inserted into the reader, the blood sample is automatically processed and analyzed within the cartridge and thus the concept is termed by the company "Lab On a Cartridge".

"We are very excited to have reached this important milestone," says Dr. Avishay Bransky PixCell's CEO, "we have solved a decades-long problem of making a miniature POC CBC tester which is widely recognized as an unmet need."

"The HemoScreen delivers lab accurate results and would be especially useful at physicians' offices, ER, ICU, Oncology clinics and remote locations," says Dr. Bransky.

In contrast to existing solutions, the HemoScreen requires no maintenance or calibration which is extremely important in such settings.

The HemoScreen™ should empower physicians to make validated, data-driven decisions: referring patients to the ER, prescribing antibiotics and other medication, ordering additional specific tests while reducing redundant tests and by that greatly improve patient care and workflow efficiency.

The CBC is the most commonly performed lab test with nearly 2 billion tests per year in the USA and Europe. The CBC provides an important tool for evaluating patients' overall health and managing a wide range of disorders including infection, anemia and leukemia.

Performance of the HemoScreen™ has been validated in numerous clinical studies in the USA and Europe, in different settings such as oncology, ICU and primary care.

The HemoScreen™ employs patented technology based on microfluidics, machine vision and artificial intelligence (AI). Utilizing a new concept: Imaging Flow Cytometry where cells are flow focused into a single layer plane within a microfluidic chamber and their images are analyzed on the fly. This approach provides high repeatability and accuracy arising from flow and high resolution and sensitivity attained by imaging.

Future assays based on the same platform technology are designed to detect the leading life-threatening diseases already at the POC i.e. cancer, infection, and heart failure.

https://www.medical-device.co.il/11895-hemoscreen-hematology-analyzer-for-point-of-care-receives-fda-510-k-clearance

 


BrainsWay Receives First Ever FDA Clearance of a Non-Invasive Device for Treatment of Obsessive-Compulsive Disorder

BrainsWay’s deep transcranial magnetic stimulation (Deep TMS) system is a best-in-class device designed to maximize electromagnetic stimulation of deep and broad brain regions, helping to launch a new era in brain disorder treatment

This clearance marks the second indication granted for BrainsWay Deep TMS, also cleared for treatment of Major Depressive Disorder in 2013

HACKENSACK, N.J., August 19, 2018 – BrainsWay Ltd. (TASE: BRIN), the parent company of BrainsWay USA, Inc., and a global leader in the advanced non-invasive treatment of brain disorders, today announces that it has received De Novo clearance from the U.S. Food and Drug Administration (FDA) for its deep transcranial magnetic stimulation (Deep TMS) system for the treatment of obsessive-compulsive disorder (OCD) in adults.

This clearance represents the first ever non-invasive medical device clearance for the treatment of OCD, and the second indication granted for BrainsWay Deep TMS, which was cleared in 2013 for the treatment of treatment-resistant major depressive disorder (MDD). BrainsWay intends to start installing BrainsWay OCD immediately as an upgrade of its current systems and as part of new installations. Clinics that have or will have a Deep TMS systems can now treat MDD and OCD patients.

“With the clearance of our BrainsWay OCD device, we are now able to provide an effective and safe treatment option for U.S. patients who are suffering from OCD,” said Yaacov Michlin, president and chief executive officer of BrainsWay. “With more than two million U.S. adults suffering from OCD, this clearance provides us with a significant market opportunity. Importantly, this clearance further establishes Deep TMS as a platform technology that will provide treatments for additional psychiatric indications, subject to successful completion of our currently ongoing multi center studies and regulatory approvals.”

BrainsWay’s Deep TMS technology differs from that of other focal TMS devices as it has broad applicability and can directly stimulate areas of the brain at a greater depth and breadth than any other TMS device on the market safely and efficiently. While other focal TMS devices are limited to treating MDD, BrainsWay can now directly target previously unreachable areas of the brain with its proprietary H7-coil, allowing it to effectively treat OCD as well.

Dr. Joseph Zohar, professor of psychiatry at the Sackler Faculty of Medicine at Tel Aviv University, chair, International College of Obsessive-Compulsive Spectrum Disorders (ICOCS) and principal pivotal trial investigator, added, “The clearance of BrainsWay’s OCD device marks a historic milestone in the treatment of this neurological disorder. This is a new groundbreaking treatment option for patients looking for a meaningful and potentially life-changing solution for OCD.”

Prof. Abraham Zangen, a scientific founder and a neurobiological consultant for BrainsWay said, “The brain region targeted with the BrainsWay H7- coil is the anterior cingulate cortex, a region known for many years to be centrally implicated in the pathophysiology of OCD. This Deep TMS H7-coil is different from the BrainsWay H1-coil used for treating depression that targets primarily the lateral pre-frontal cortex. The modulation of the anterior cingulate cortex induced by BrainsWay’s special H7- coil, combined with the individualized provocation procedure in addition to the continued pharmacological or psychological treatment, will allow effective treatment for millions of OCD patients.”

https://www.brainsway-global.com/news_events/brainsway-receives-first-ever-fda-clearance-of-a-non-invasive-device-for-treatment-of-obsessive-compulsive-disorder222/

Tyto Care Receives CE Mark for Its On Demand, Remote Examination Solution

Tyto Care, an innovative telehealth company enabling on demand telehealth visits and comprehensive medical examinations, today announced it received CE Mark approval and that its end-to-end telehealth solution is now available for European consumers and professionals.

CE Mark approval paves the way for the immediate European roll out of Tyto Care’s comprehensive solution, which includes an otoscope, stethoscope, digital camera, and telehealth platform. The roll out will take place via partnerships with leading telehealth companies, health systems, and insurance providers.

Following its FDA clearance and product launch in the United States in 2017, Tyto Care has gained significant traction with major US health systems, telehealth companies, large private practices, and employers. Tyto includes a hand-held modular examination tool to remotely examine the heart, lungs, skin, ears, throat, and abdomen. Exam data can be shared with a clinician in real time as a live video telehealth visit or in advance of a telehealth session (‘exam and forward’) for a remote diagnosis. The platform includes proprietary self-guidance technology that enables anyone to easily and accurately capture exam data remotely.

https://www.tytocare.com/news-and-events/tyto-care-receives-ce-mark-for-its-on-demand-remote-examination-solution/

 

 


Zebra Medical Vision Announces CE Approval Of Its Seventh AI Imaging Algorithm - Mammography Lesion Detection

SHEFAYIM, Israel -- Zebra Medical Vision (http://zebra-med.com/) announces today the CE regulatory approval of its newest algorithm to be included in its growing Deep Learning Imaging Analytics platform. The algorithm, capable of detecting suspected malignant lesions in Mammography scans - is the latest addition to other automated tools announced in the past as part of it's "All-In-One" AI1 business model, among them algorithms that automatically detect brain bleeds, vertebral fractures, coronary artery disease, osteoporosis and more.

According to the American Cancer Society, breast cancer makes up 25% of all new cancer diagnoses in women globally - with nearly 1.7 million women being diagnosed annually. Survival rates, though improving - vary worldwide. In countries with advanced care, the rate is 80 to 90 percent for those with a first-stage diagnosis, and 24 percent if diagnosis occurs at a later stage. In developing countries the mortality rate is much worse, in large part due to the lack of early diagnostic capabilities. This lends significant importance to screening programs, that have the ability to detect breast cancer in its early stages.

Existing software solutions, called Mammo CAD (computer aided-detection) have been marketed for a number of years - attempting to assist mammographers in identifying suspicious lesions in mammography scans. Unfortunately, the large number of false alarms, coupled with a price tag that has placed these products within reach of only wealthier healthcare economies, have not led to widespread adoption globally.

Zebra-Med's Mammography algorithm aims to change that dynamic, by providing a state of the art malignancy detection product at a previously unprecedented price point. The first version to be released supports 2D Hologic devices, and Zebra Medical Vision expects to add support for additional vendors, as well as 3D support during the course of 2019. The algorithm broadens Zebra-Med's AI1 "All-In-One" Imaging Analytics package, which has already analyzed more than 1M scans in over 5 countries.

"Early detection of breast cancer is a crucial component of disease prevention," says Dr. Michael Fishman, a breast imaging radiologist at Beth Israel Deaconess Medical Center in Boston, Massachusetts. "An accurate AI assistant can provide a significant boost to radiologists seeking to provide the best care for their patients by increasing detection and limiting false positives."

"We have taken great care to produce a high performance aid in the detection of suspected malignant lesions," says Elad Benjamin, Co-Founder and CEO of Zebra Medical Vision. "Mammography tools have had a checkered past, and we plan to usher a new level of performance with this algorithm and its follow on versions."

https://www.medical-device.co.il/11628-zebra-medical-vision-announces-ce-approval-of-its-seventh-ai-imaging-algorithm-mammography-lesion-detection

 


Oxitone Medical Receives FDA Clearance for Wrist-Sensor Pulse Oximetry Bracelet

Medical device and digital health startup Oxitone Medical launches the first to market wrist-sensor pulse oximetry bracelet to transform delivery of chronic disease home care.

Oxitone Medical (Oxitone), an Israeli-based medical device and digital health company developing wearable monitoring solutions to transform delivery of chronic disease home care, has received 510(k) clearance from the FDA for its wrist-sensor pulse oximetry bracelet Oxitone 1000. The wrist-sensor pulse oximeter Oxitone 1000 measures critical vital signs such as SpO2 and pulse rate with the same precision as conventional fingertip pulse oximeters. Oxitone 1000 becomes the first to market a wrist-sensor pulse oximeter that offers comfortable real-time monitoring with high patient compliance.
The Oxitone solution has been validated in pilot studies in a number of medical settings including desaturation labs. The results have proven almost 100% patient satisfaction, significant reduction of medical staff workload and a potential for major reduction in readmission. Oxitone FDA clearance paves the way towards supervision of patients beyond hospital walls while providing the hospital’s medical-grade level of care.
About Oxitone Medical Ltd. 
Oxitone is an Israeli-based medical device and digital health company focused on developing cutting edge wearable and digital medical technologies for medical systems, clinics, nursing homes, telemedicine companies, payers and providers. The flagship product is the world’s first FDA-approved wrist-sensor pulse oximetry bracelet Oxitone 1000. The company is a participant in StartUp Health and Texas Medical Center (TMCx) startup accelerator programs.
For more information, please visit: http://www.oxitone.com