FDA 510(k) cleared Respiration Rate analytic adds to physIQ’s growing portfolio of FDA 510(k) algorithms
The MEDICREA® Group (Euronext Growth Paris: FR0004178572 – ALMED ; OTCQX Best Market – MRNTF), pioneering the digital transformation of spinal surgery through Artificial Intelligence, predictive modeling and patient specific implants with its UNiD™ ASI (Adaptive Spine Intelligence) proprietary software platform, services and technologies, announced today that it has received FDA-Clearance for TULIP GENESIS™ which completes its UNiD™ ASI platform technology.
KEYTRUDA Now Approved for Recurrent Locally Advanced or Metastatic Squamous Cell Carcinoma of the Esophagus in Patients Whose Tumors Express PD-L1 (CPS ≥10) With Disease Progression After One or More Prior Lines of Systemic Therapy
Mesa Biotech Inc. is a privately-held, molecular diagnostic company that has developed the Accula™ System, an affordable, sample-to-answer, CLIA-waived PCR (polymerase chain reaction) testing platform designed specifically for point-of-care (POC) infectious disease diagnosis
The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) announced that the University of Delaware, on behalf of NIIMBL, has entered into a Collaborative Research and Development Agreement (CRADA) with the Food and Drug Administration (FDA).
Interventional Nephrologist Neghae Mawla, MD, pioneers minimally invasive fistula creation in Texas
Solio (https://www.soliotherapy.com/) recently announced the release of its innovative Alfa Plus, after receiving FDA clearance.
NeuroVive Pharmaceutical AB (Nasdaq Stockholm: NVP) (OTCQX: NEVPF) announced that the company's candidate drug NeuroSTAT, in development for treatment of moderate to severe traumatic brain injury, TBI, has received Fast Track designation from the US Food and Drug Administration, FDA, facilitating its clinical development and path forwards to market.
Latest QTbreasthealth center now open within Scottsdale's Vincere Cancer Center, defining a new generation of breast imaging for women
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NDA Seeks Approval for Brinavess for the Treatment of Recent Onset Atrial Fibrillation; PDUFA Date Set for December 24, 2019
Immix receives FDA letter activating the IND for IMX-110
Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that it has received clearance from the U.S. Food and Drug Administration ("FDA") to clinically investigate LPCN 1144 in an expanded target population of adult male non-alcoholic steatohepatitis ("NASH") patients.
European Patent Office Approves Core Patent Covering Soliton's RAP Technology
STA Pharmaceutical Co., Ltd., (WuXi STA) – a subsidiary of WuXi AppTec – announces that its Analytical Service Unit (ASU) in Shanghai and active pharmaceutical ingredient (API) process R&D and manufacturing facility in Changzhou, have successfully passed two inspections from the U.S. Food and Drug Administration (FDA) within the same week, with no Form 483s issued.
MiRus™ Receives FDA 510(k) Clearance for the GALILEO™ Spine Alignment Monitoring System
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Water Street Healthcare Partners, a strategic investor focused exclusively on the health care industry, announced today that its development partnership with a leading medical products company has resulted in the U.S. Food and Drug Administration (FDA) approval of Insulin Human in 0.9% Sodium Chloride Injection (Insulin Human).
The U.S. Food and Drug Administration announced it has recently suspended the food facility registration of Topway Enterprises Inc., also doing business as Kazy’s Gourmet, of Houston, Texas. Topway now cannot sell or distribute any food into commerce.
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MED-EL’s are the First and Only Cochlear Implants to Be Granted Indications for Traditionally Underserved Population
Offers extended shelf life of 30 days at room temperature or 24 months refrigerated