EBR Systems, Inc., developer of the world’s only wireless cardiac pacing system for heart failure, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the WiSE CRT System for the treatment of heart failure.
Checkpoint Surgical, Inc., a leader in hand-held, intraoperative neurostimulation technology for nerve protection and repair, announced it has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for the Checkpoint brief electrostimulation therapy (BEST) system.
Investigational oral MET inhibitor has previously received SAKIGAKE 'fast-track' regulatory designation in Japan
United Therapeutics Corporation (Nasdaq: UTHR) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Trevyent® (treprostinil) for the treatment of pulmonary arterial hypertension (PAH).
Delta 3300 Is A Compact and Light Weight Precision Instrument Ideal for Testing all Defibrillators and Pacemakers
FDA and its stakeholders have an interest in assuring the integrity of clinical trial data and the protection of participants during the conduct of clinical research.
Vantage Solutions, the manufacturing efficiency experts, today announced it is supporting the Food and Drug Administration (FDA) Pilot for Verification Router Service (VRS) testing sponsored by rfxcel.
Compounded drugs can serve an important medical need for certain patients, however, they also present risksExternal Link Disclaimer to patients since they are not evaluated by the FDA for safety, effectiveness and quality.
The ANSI National Accreditation Board (ANAB), a wholly-owned subsidiary of the American National Standards Institute, has accredited Global Standards S.C. (GSSC) in accordance with the international standard, ISO/IEC 17065, Conformity assessment—Requirements for bodies certifying products, processes, and services, and pertinent certification scheme requirements and regulations under the U.S. Food and Drug Administration (FDA)'s Food Safety Modernization Act, or FSMA.
Company’s New Collagen-Enhanced Bone Graft Material Receives US FDA 510(k) Clearance and Enters Domestic Market
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WONTECH, a leading Korean medical device company, announced that its Holmium laser device, Holinwon Prima, received U.S. Food and Drug Administration approval.
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Bardy Diagnostics, Inc., ("BardyDx"), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced today it received 510(k) clearance from the U.S. Food and Drug Administration ("FDA") for the 14-Day version of the Carnation Ambulatory Monitor ("CAM™"), the industry's only P-wave centric™ ambulatory cardiac patch monitor and arrhythmia detection device.
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Endo International plc (NASDAQ: ENDP) announced today that the Company has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for collagenase clostridium histolyticum (CCH) for the treatment of cellulite in the buttocks.
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Ridgeback Biotherapeutics LP, a closely held biotechnology company, today announced that the Food and Drug Administration has recently granted mAb114, an experimental treatment for Ebola, Breakthrough Therapy designation.
A new study shows that a simple, non-invasive “contrast enhanced ultrasound” (CEUS) scan can be more accurate and reliable than a more expensive MRI procedure for diagnosis of liver tumors and determining whether they are cancerous.
The cutting-edge CBCT imaging system, an integrated solution with 2D and 3D imaging, is now available to Mevion systems in the U.S.
New joint preserving implant compatible with the Toe HemiCAP DF® and ToeMotion™ Systems
Astex Pharmaceuticals, Inc., a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., based in Tokyo, Japan, announces that the US Food & Drug Administration (FDA) has granted orphan drug designation for the company’s orally administered fixed-dose combination of cedazuridine and decitabine (ASTX727 or C-DEC) for the treatment of myelodysplastic syndromes (MDS) including chronic myelomonocytic leukemia (CMML).
A federal court has ordered two Tennessee-based companies and their owner to stop distributing drugs, dietary supplements and devices until the companies comply with the Federal Food, Drug, and Cosmetic (FD&C) Act and other requirements listed in a consent decree.
SHINKEI Therapeutics., a clinical stage pharmaceutical company focused on the development of therapeutic drugs for the treatment of Central Nervous System (CNS) disorders, today announced that they received notification from Food and Drug Administration (FDA), stating that FDA has accepted the filing of an Investigational New Drug (“IND”) application for MR-301 for the treatment of Severe Traumatic Brain Injury (sTBI) resulting in minimally conscious and/or vegetative comatose state.