US-based medical aesthetics provider Solta Medical has received 510(k) approval from the US Food and Drug Administration (FDA) for its Fraxel DUAL 1550/1927 laser system, which can be used to treat pigmented lesions including solar lentigos ...
The US Food and Drug Administration (FDA) has accepted the new drug application (NDA)from DURECT, a specialty pharmaceutical company, for its Posidur (Saber-Bupivacaine) investigational candidate. Designed to offer up to three days of ...
Beckman Coulter, a subsidiary of Danaher Corporation, has received 510(k) approval from the US Food and Drug Administration (FDA) for its new Access AccuTnI+3 troponin I assay for use in its Access 2 immunoassay system. In October 2010, ...
Tags: Beckman Coulter, Medicine
Specialty pharmaceutical company TherapeuticsMD has obtained investigational new drug (IND) application clearance from the US Food and Drug Administration (FDA) for vaginal estradiol suppository, TX12-004HR. The IND acceptance will allow ...
The US Food and Drug Administration (FDA) has urged medical device manufacturers to boost their security protection systems against cyber attacks, which could compromise the safety and privacy of patients. According to the agency's safety ...
Tags: Medical Devices, Cyber Attacks
The US Food and Drug Administration (FDA) has given its clearance to Amgen's XGEVA (denosumab) to treat adult or skeletally mature patients suffering from giant cell tumor of bone (GCTB). Approved after conducting a priority review, XGEVA ...
Tags: Amgen's XGEVA, Medicine
Cordis Corporation, a part of the Johnson & Johnson Family of Companies, has received approval from the US Food and Drug Administration (FDA) for its Adroit 6F Guiding Catheter. Enabling the production of a guide catheter with the largest ...
Abyrx, a US-based therapeutic device company, has received the US Food and Drug Administration (FDA) approval for its new Absorbable Hemostatic Bone Putty (AHBP) for clinical use. AHBP is a surgical ready-to-use product which achieves ...
Tags: Abyrx, Bone Putty
St. Jude Medical, a medical device manufacturer, has received US Food and Drug Administration (FDA) approval for its next-generation Ellipse and SJM Assura portfolio of implantable cardioverter defibrillators (ICDs) and cardiac ...
Tags: St.Jude, SJM Assura Devices
Cumberland Pharmaceuticals has received the US Food and Drug Administration’s (FDA’s) approval for updated labeling of Acetadote (acetylcysteine) Injection, which is free from Ethylene diamine tetracetic acid (EDTA) or any other ...
Tags: Cumberland, Labeling of Acetadote
The US Food & Drug Administration (FDA) has issued a tentative approval letter to Supernus Pharmaceuticals for its Trokendi XR (extended release topiramate) in the treatment of epilepsy. Following to completion of review of the Trokendi ...
Tags: Supernus Trokendi, FDA Approval
US-based Cumberland Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for updated labeling for Acetadote (acetylcysteine) Injection. According to the company, the new labeling revises the indication of ...
Julian’s Recipe is voluntarily recalling European Style Pretzel Baguette packages from HEB Stores in Texas, US, over allergy concerns. According to the company, certain packages of Pretzel Baguettes may contain Julian's European ...
Respitek, a South Africa-based disposable medical devices maker, has received the US Food and Administration (FDA) clearance for the Bobbi Baby Shield, which is meant to shield against infection post Hypospadias repair surgery. Meant for ...
Tags: Respitek, Bobbi Baby Shield
The US Food and Drug Administration (FDA) is evaluating the safety of Intuitive Surgical's robotic surgical devices. Currently, the agency is studying a small group of surgeons who use the surgical device, which is used in over 2,000 ...