Boston Scientific has completed enrolling first patient in a EVOLVE II clinical trial of its Synergy Everolimus-Eluting platinum chromium coronary stent system. The CE-marked stent features a combination of everolimus drug and ...
Tags: Synergy Everolimus Eluting platinum chromium coronary stent system
Bracco Diagnostics (BDI) has recalled nine lots of Isovue PFS injector syringes, to be used in combination with stellant CT injection systems due to the presence of visible particles in syringes in the US. The particles were observed at ...
Tags: Bracco Diagnostics, injector syringe, stellant CT injection systems
There's been a lot of buzz lately about the safety of energy drinks and shots. Following reports of harmful reactions and even deaths possibly associated with the products, two U.S. senators recently released a letter from the FDA stating ...
Tags: Energy Drinks, Drinks
Hospira has announced a nationwide voluntary recall of one lot of Hydromorphone Injection, USP, 2mg/mL (C-II), 1mL fill in 2.5mL Carpuject, NDC 0409-1312-30 , due to a reported complaint of a single Carpuject containing more than the 1mL ...
AstraZeneca has published a new study that demonstrates that Symbicort Inhalation Aerosol 320/9 μg twice daily has a safety profile similar to Budesonide pressurized metered-dose inhaler (pMDI) 320 μg twice daily for asthma. In a ...
Tags: asthma, drug relationship, use of Symbicort
American Regent has issued a retail/hospital level recall of Epinephrine Injection, USP, because of discoloration and small visible particles found in some ampules of lot #1395. The adverse events after intravenous administration of ...
Tags: Epinephrine Injection, USP, Luitpold Pharmaceuticals, American Regent
GI medical devices developer Given Imaging has submitted an application to US Food and Drug Administration(FDA)seeking approval to use its non-invasive imaging tool for visualization of the lower gastrointestinal tract. The PillCam Colon ...
Tags: PillCam Colon 2 capsule endoscopy system, Given Imaging
The USFDA has approved ThromboGenics'Jetrea(ocriplasmin)for the treatment of symptomatic vitreomacular adhesion(VMA). The approval was based on the Phase III trial data which demonstrated that Jetrea is superior to placebo for the ...
Tags: ThromboGenics'Jetrea, symptomatic vitreomacular adhesion, USFDA
Sotera Wireless has won FDA 510(k) clearance for its full ViSi Mobile System and is commencing sales to hospitals nationwide. The ViSi Mobile System, which consists of a small device and non-invasive sensors for freedom of movement, is ...
Brand New Energy(BNE),a dietary supplement re-sale distributor,is recalling all lot codes of dietary supplement EphBurn 25 due to possible health risk,according to the US Food and Drug Administration(FDA). The recall was initiated after ...
Tags: FDA, dietary supplement, health risk, ephedrine alkaloids, stimulant
Cytochroma, a clinical stage specialty pharmaceutical company, has selected OmniComm Systems' eClinical Suite of applications for its two Phase III studies. OmniComm's eClinical Suite, including the EDC, CTMS, Safety, and Coding ...
Tags: Cytochroma, clinical stage, eClinical Suite, patient data, adverse events
St Joseph Hospital has enrolled first patient for SYMPLICITY HTN-3 trial, conducted by Medtronic, designed to assess investigational Symplicity renal denervation system. Minimally invasive, catheter-based renal denervation procedure is ...
Tags: renal denervation system, catheter-based renal denervation
Terumo Interventional Systems has completed enrolling patients in its Occlusive/Stenotic Peripheral Artery REvascularization StudY (OSPREY). The MISAGO stent comprises a nitinol stent pre-mounted on the distal portion of a rapid-exchange ...
Tags: OSPREY Trial, Misago Stent system, superficial femoral artery
Astellas Pharma and Medivation have announced the submission of marketing authorization application (MAA) to the European Medicines Agency (EMA) for enzalutamide to treat metastatic castration-resistant prostate cancer in men who have ...
Tags: enzalutamide, metastatic castration-resistant prostate cancer