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Companies Related to "[Trial of device that is not approved or cleared by the U.S. FDA]" [Most Relevant Company Matches] RSS

12:56 EDT 22nd July 2018 | BioPortfolio

Here are the most relevant search results for "[Trial of device that is not approved or cleared by the U.S. FDA]" found in our extensive corporate database of over 50,000 company records.

Showing "Trial device that approved cleared" Companies 1–25 of 2,800+

Relevant

Tissue Regeneration Technologies, LLC

TRT is an international medical device company established to develop, manufacture and sell SoftWaveTM acoustical pressure pulse devices to treat various conditions poorly served by the current standard of care. TRT is headquartered in Woodstock, Georgia. Production of TRT’s devices is handled by its manufacturing subsidiary, MTS Europe GmbH, located ...


Vascular Pathways Inc.

Vascular Pathways, founded by Amir Belson, M.D., is a privately held medical device company focused on commercializing the Rapid IntraVascular Start (RIVS) catheter, an FDA cleared device enabling rapid, safe and successful peripheral IV insertion.

SANUWAVE Health, Inc.

SANUWAVE Health, Inc. (www.sanuwave.com) is an emerging regenerative medicine company focused on the development and commercialization of non-invasive, biological response activating devices for the repair and regeneration of tissue, musculoskeletal and vascular structures. SANUWAVE’s portfolio of products and product candidates activate biologic sign...


Possis Medical

Possis Medical, Inc. is pioneering mechanical thrombectomy, i.e. the rapid, safe and effective removal of blood clots from native arteries and veins, as well as from synthetic and saphenous vein grafts. The Company currently has a portfolio of three FDA indications for use of its AngioJet® Rheolytic™ Thrombectomy System. The system has been used to treat over 250,000 patients in 1,400 locations...

Notal Vision, Inc.

Notal Vision was founded by two ophthalmologists, and is committed to providing retina specialists with innovative, home-based, technology solutions that support visual health in patients with AMD. The company's ForeseeHome® device is the first FDA-cleared home telemonitoring device that detects and characterizes visual distortion in AMD patients as an ...

STATKING Clinical Services

STATKING Clinical Services provides clinical trial services (biostatistics, clinical data management, clinical study monitoring, medical writing, safety reporting, project management and clinical trial management) for clinical trials for the regulatory approval of novel drug and medical device products. The company is headquartered in Fairfield, OH. The co...

Fluidigm Corporation

Fluidigm develops, manufactures and markets proprietary Integrated Fluidic Circuit (IFC) systems that significantly improve productivity in life science research. Fluidigm’s IFCs enable the simultaneous performance of thousands of sophisticated biochemical measurements in extremely minute volumes. These “integrated circuits for biology” are ...

Notal Vision

Notal Vision was founded by two ophthalmologists, and is committed to providing retina specialists with innovative, home-based, technology solutions that support visual health in patients with AMD. The company’s ForeseeHome® device is the first FDA-cleared home tele-monitoring device that detects and characterizes visual distortion in AMD patients as an ...

Privia

A clinical trial is a research study. Research studies are used to decide how treatments work and how safe they are. While in a study, a person may receive either an investigational drug, a marketed drug, a placebo, or a combination of these. An investigational drug is one that is nor approved by the Food and Drug Administration, a marketed drug is FDA approved and a placebo is like a "sugar pill"...

U-Systems

U-Systems is the leader in developing automated breast ultrasound systems and the sponsor of the SOMO•INSIGHT multi-center study that will enroll up to 20,000 women at clinical study sites in the United States to determine the sensitivity of mammography and somo•v Automated Breast Ultrasound Systems (ABUS) together, compared to mammography alone for ...

GI Dynamics Inc.

GI Dynamics, Inc. (ASX:GID) is the developer of EndoBarrier, the first endoscopically-delivered device approved for the treatment of type 2 diabetes and obesity. EndoBarrier is not approved for sale in the United States and is limited by federal law to investigational use only in the United States. Founded in 2003, GI Dynamics is headquartered in Boston, M...

Amplion Research Inc.

Amplion Research develops business intelligence tools for the diagnostics industry. Along with research reports, Amplion Research also published BiomarkerBase™, the database of every FDA-cleared or approved test for a molecular biomarker (http://www.biomarkerbase.com).

Clinical Assistance Programs

Clinical Assistance Programs (CAP) is a clinical trial management organization. CAP provides site and data quality management, investigator training, and specialized compliance services to life science companies engaged in clinical trials.CAP was created to address many of the problems inherent in the clinical trial process such as site variability, data accuracy, investigator compliance, and the ...

NitroMed

NitroMed, Inc. of Lexington, Massachusetts is a research-based emerging pharmaceutical company and the maker of BiDil, an orally administered medicine available in the United States for the treatment of heart failure in self-identified black patients. In this population, BiDil is indicated as an adjunct to current standard therapies such as ACE inhibitors and/or beta blockers. BiDil was approved b...

MELA Sciences, Inc.

MELA Sciences is a medical device company developing dermatology diagnostics utilizing state-of-the-art optical imaging. The Company’s flagship product is MelaFind®, an FDA approved, non-invasive diagnostic tool to aid dermatologists in melanoma evaluation and diagnosis. MelaFind® uses a variety of visible to near-infrared light waves to evaluat...

physIQ, Inc.

PhysIQ is a company dedicated to enabling proactive care delivery models through its Personalized Physiology Analytics (PPA) and highly scalable cloud-based platform. The FDA 510k-cleared data analytics platform is designed to process multiple vital signs from wearable sensors to create a personalized dynamic baseline for each individual. By mapping vital ...

Socrates Health Solutions, Inc.

Socrates Health is developing Socrates CompanionTM, a small, inexpensive and noninvasive blood glucose self-monitoring device that has not yet been cleared by the FDA and is currently not for sale.

Bruin Biometrics, LLC

Bruin Biometrics (BBI) is relentlessly committed to using technology to improve the way that health care is delivered. By developing innovative biometric medical device systems that can cost-effectively detect and monitor select medical conditions with urgent clinical need, BBI is helping inform clinical decisions, simplify patient care, and improve pat...

CTI Clinical Trial and Consulting Services

CTI Clinical Trial and Consulting Services is a global, privately held, full-service contract research organization (CRO). CTI’s focused therapeutic approach provides pharmaceutical, biotechnology, and medical device firms with clinical and disease area expertise. CTI has a passion for helping life-changing therapies succeed in chronically and critica...

ClinicalConnection, Inc.

ClinicalConnection.com (www.ClinicalConnection.com) has referred more than 150,000 patients to clinical trials and featured over 10,000 studies. Headquartered in Boston, Massachusetts, ClinicalConnection, Inc. provides a suite of patient recruitment services for the pharmaceutical development and medical device sectors. Services include customized clinical...

U-Systems, Inc.

U-Systems is the leader in developing dedicated breast ultrasound systems. For more information about the company, please visit our website at http://www.u-systems.com. For further information about the SOMO·INSIGHT clinical study, visit www.somoinsightstudy.org. The U-Systems somo•v Automated Breast Ultrasound System (ABUS) is currently cleared un...

PharmaVigilant

Based in Westborough, Mass., PharmaVigilant is a SaaS company founded in 2005 to provide broader technologies to streamline the clinical trial process for biotech, pharmaceutical and medical device companies. Its full suite of integrated technology products and services automates the collection, management and analysis of essential documents and clinical t...

Factory-CRO BV

Factory was founded in 1988 by Joris Bannenberg and Dirk Meyer. Both hold a PhD in biomaterials and surgical technology and have over 15 years of experience in medical device studies. In the first years their activities consisted mainly of consulting for medical device companies. The first contract research activities date back to 1994. After gaining extensive experience in experimental surgery an...

TechniScan, Inc.

Based in Salt Lake City, Utah, TechniScan, Inc. is a medical device company engaged in the development and commercialization of a non-invasive imaging tool designed to provide physicians with automated ultrasound images of the human breast. The system, known as SVARA ™, uses a process called Warm Bath Ultrasound (WBU™) to provide physicians with ...

MedTrials, Inc.

Established in 1993, MedTrials has developed into a fully integrated clinical research services firm with full-service capabilities for phase II-IV clinical studies including:Monitoring Auditing Consulting Training Data management Project management Statistical analysis We partner with pharmaceutical, medical device, and biotech companies alike to help get new, groundbreaking products approved and...


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