Insulet Corporation (NASDAQ: PODD) (Insulet), the global leader in tubeless insulin pump technology with its Omnipod® Insulin Management System, today announced it has received clearance from the U.S. Food and Drug Administration (FDA) for an Alternate Controller Enabled Infusion Pump (ACE Pump).
The U.S. Food and Drug Administration (FDA) removed the alcohol contraindication from Addyi, the only FDA-approved treatment for pre-menopausal women for Hypoactive Sexual Desire Disorder (HSDD).
ResearchAndMarkets.com held a seminar in San Diego on Sept. 12 and 13 entitled, "Managing Your Complaints and Obstacles in Post-Market Requirements – Results from Top Medical Device Observations During an Inspection.”
The most important technology to embrace the beauty industry in the past decade.
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Medicure Inc. ("Medicure" or the "Company") (TSXV:MPH, OTC:MCUJF), a cardiovascular pharmaceutical company, is pleased to announce the launch of the ReDSTM PRO ("ReDSTM PRO") system, the next generation of lung fluid management technology for heart failure.
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.
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.
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.
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
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.
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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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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.
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
Karolinska Development's portfolio company Promimic today announced that the company’s first spinal device utilizing HAnano Surface to improve osseointegration has now been 510(k) approved by the FDA.