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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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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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WONTECH, a leading Korean medical device company, announced that its Holmium laser device, Holinwon Prima, received U.S. Food and Drug Administration approval.
Company’s New Collagen-Enhanced Bone Graft Material Receives US FDA 510(k) Clearance and Enters Domestic Market
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.
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.
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.
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.
Delta 3300 Is A Compact and Light Weight Precision Instrument Ideal for Testing all Defibrillators and Pacemakers
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).
Investigational oral MET inhibitor has previously received SAKIGAKE 'fast-track' regulatory designation in Japan
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.
The U.S. Food and Drug Administration held 10 public meetings related to the review of license applications for drugs and biologics during the first three quarters of fiscal-year 2019, the regulatory agency reported last month.
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.
If Approved, Teprotumumab Would be the First FDA-Approved Medicine for this Vision-Threatening Disease
Representative Jim Struzzi (R-IN) introduced two new bills that have the potential to regulate cannabidiol (CBD) and kratom sales in Pennsylvania.
The FDA has issued new draft guidance for labeling of prescription medications that could be abused, with the goal of making the risks of dependence clearer for health care providers and for patients.
The Food and Drug Administration (FDA) has granted a submission for a Breakthrough Device designation from Prescient Metabiomics for its LifeKit Prevent Colorectal Neoplasia Test for the early detection of colon polyps and colon cancer.
Sofwave Medical Ltd., an emerging aesthetic device company, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Sofwave system. The Sofwave device is indicated for use as a non-invasive aesthetic treatment to improve facial lines and wrinkles.
Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, has announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the JuggerStitch™ meniscal repair device.