Microsulis Medical has obtained the US Food and Drug Administration's (FDA) approval for upgraded version of its Accu2i pMTA applicator, designed for use as part of the company's Acculis Microwave Tissue Ablation (MTA) system. The Accu2i ...
Tags: Medical, microwave tissue ablation applicator, applicator
The US Food and Drug Administration (FDA) has cleared Boston Scientific's subcutaneous implantable cardioverter defibrillator (S-ICD) to treat patients at risk for sudden cardiac arrest (SCA). The CE-marked system, which the company ...
Tags: FDA, CE-marked system, S-ICD system
Eisai's Aciphex (rabreprazole sodium) has met the FDA's Written Request requirements for pediatric exclusivity in US. Having met FDA's requirement, the company has now gained an additional 6 months US market exclusivity for Aciphex, which ...
Tags: rabreprazole sodium, FDA, Aciphex, pediatric drug, GERD Drug
Janssen Research & Development has submitted a New Drug Application (NDA) to the US FDA seeking approval for a fixed-dose therapy combining canagliflozin and immediate release metformin to treat patients with type 2 diabetes. ...
Medivation and Astellas Pharma have announced FDA approval for Xtandi (enzalutamide) capsules to treat metastatic castration-resistant prostate cancer in patients with previously received docetaxel. Medivation and Astellas expect to make ...
Tags: Medivation, Astellas, FDA
Precision Spine has gained US marketing rights for its minimally invasive spinal fixation system, following the Food and Drug Administration's (FDA) approval. The Mini-Max minimally invasive access system, which is designed for use with ...
Tags: US, FDA, Precision Spine
Astellas Pharma US is seeking FDA approval for Tarceva tablets to treat non-small cell lung cancer patients (NSCLC) with tumors containing epidermal growth factor receptor (EGFR) that triggers mutations. The company submitted a ...
Merit Medical Systems has gained US marketing rights for its ONE Snare Endovascular Snare system, following the Food and Drug Administration's (FDA) approval. Single-loop snare system is designed to provide both accuracy and reliability ...
Tags: Merit Medical Systems, ONE Snare Endovascular Snare system, FDA
Janssen's Zytiga indicated for metastatic castration-resistant prostate cancer(mCRPC),has won FDA approval for use in patients who have not received chemotherapy. The oral,once-daily medication was previously used in combination with ...
The US Food and Drug Administration(FDA)has approved Ethicon Biosurgery's new fibrin sealant patch to aid surgeons in stopping problematic bleeding during surgery. The fibrin sealant patch,EVARREST,comprises a coating of biologics(human ...
The European Union has granted CE mark approval to InSightec's transcranial focused ultrasound system for the treatment of essential tremor, tremor dominant Parkinson's disease and neuropathic pain. The non-invasive ExAblate Neuro ...
Tags: transcranial focused ultrasound system, Parkinson's disease
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Biosign Technologies' non-invasive blood pressure measurement system, Pulsewave monitor. The UFIT EN-10 monitor is worn on the wrist having 13.5 cm to 23 cm (5.3 ...
Tags: FDA, blood pressure measurement system, pulsewave monitor, systolic
Lupin Pharmaceuticals has gained FDA approval for its Norgestimate and Ethinyl Estradiol tablets, 0.18mg/0.025mg, 0.215mg/0.025mg, and 0.25mg/0.025mg. Norgestimate and Ethinyl Estradiol tablets are indicated for the prevention of ...
Tags: Lupin Pharmaceuticals, norgestimate and ethinyl estradiol tablets
LDR has secured an approval letter from the US Food and Drug Administration (FDA) for its low-profile cervical intervertebral disc. The Mobi-C disc, which is a metal and polyethylene mobile bearing prosthesis, is a cervical implant ...
Tags: LDR, FDA, approval letter, cervical intervertebral disc, Mobi-C disc
Medgenics has filed an investigational new drug (IND) application with the FDA to initiate a Phase IIb multi-center, 100-patient clinical trial. The trial is designed to evaluate the safety and efficacy of sustained erythropoietin (EPO) ...