Allegro Ophthalmics has received approval from the US Food and Drug Administration (FDA) for its Investigational New Drug (IND) application to commence two Phase II clinical studies of integrin peptide therapy ALG-1001. The new trials, ...
Tags: Eye Disease Patients
SuperSonic Imagine, a medical ultrasound company, announced its Aixplorer MultiWave ultrasound system has obtained the US Food and Drug Administration (FDA) approval for the quantification capabilities of its real-time ShearWave ...
Tags: SuperSonic Imagine, Medicine
Mylan Pharmaceuticals, a subsidiary of Mylan, has introduced Voriconazole for oral suspension, 40 mg/mL, which is the first generic version of Pfizer's VFEND for oral suspension. The US Food and Drug Administration (FDA) has granted a ...
Tags: Mylan, Antifungal Drug
Actuated Medical, a US-based medical device company, has obtained the additional US Food and Drug Administration (FDA) approval for its TubeClear system. The company has added several new clearing stem models for the TubeClear system and ...
Tags: Actuated Medical, medical device
Purdue Pharma has obtained approval from the US Food and Drug Administration (FDA) for the launch of a new 15mcg/hr dosage strength of Butrans (buprenorphine) Transdermal System CIII. Following the approval, Butrans will be available in ...
Tags: Pain Drug, Purdue Pharma
Medtronic, a US-based manufacturer of implantable heart-rhythm devices, has obtained the US Food and Drug Administration (FDA) approval for the Complete SE (self-expanding) vascular stent for use in superficial femoral artery (SFA) and ...
Tags: Medtronic, Lower Extremities
US-based Crosstrees Medical has obtained 510(k) approval from the US Food and Drug Administration (FDA) for the Crosstrees PVA pod system for percutaneous vertebral augmentation (PVA). The FDA approval for the CE marked Crosstrees PVA pod ...
Quidel has obtained the US Food and Drug Administration (FDA) approval for two infectious disease tests that run on Life Technologies' QuantStudioDx instrument. Life Technologies' QuantStudioDx instrument offers the advanced capabilities ...
Tags: Diagnostic Tests, Quidel
Vital Access, a manufacturer of surgical and interventional technologies, has secured the US Food and Drug Administration (FDA) market approval for its VWING device, a vascular needle guide developed to enable vascular access to ...
Tags: Vital Access, VWING device
Dfine, a manufacturer of spinal disease treatment devices, has obtained CE Mark approval for its STAR tumor ablation system, designed to treat painful metastatic spinal tumors. The STAR tumor ablation system uses radiofrequency (RF) ...
Tags: Dfine, Tumor Ablation System
CAS Medical Systems (CASMed), a medical technology company, has announced the initial sales of its next-generation Fore-Sight Elite cerebral oximetry products. The Fore-Sight Elite is lighter and more portable than the earlier model, with ...
Richter-Helm, a full-service biopharmaceutical contract development and manufacturing organization, has announced that the US Food and Drug Administration has approved two Richter-Helm facilities in Hamburg and at Bovenau (to the north of ...
IntelligentMDx (IMDx) has received the US Food and Drug Administration (FDA) approval for its second automated molecular diagnostic test for use on Abbott's fully automated m2000 platform. The automated molecular diagnostic test detects ...
ICU Medical has received the US Food and Drug Administration (FDA) 510(k) clearance for its ChemoLock needlefree closed system transfer device (CSTD). The CSTD is approved for pharmacy applications (product code ONB), as well as patient ...
Tags: ICU Medical, FDA Approval
CSL Behring has received approval from the US Food and Drug Administration (FDA) for a new 10g (50mL) vial size of Hizentra, an immune globulin subcutaneous (human) liquid drug. Hizentra, which is claimed to the first and only 20% ...
Tags: CSL Behring, Hizentra