CeloNova BioSciences said today it won FDA approval for its Cobra PzF nanocoated coronary stent system. The device is now cleared with indications for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to de novo lesions in native coronary arteries with a reference vessel diameter of 2.5-4mm and lesion length of less […]
Food & Drug Administration (FDA)
Abbott wins FDA nod for FlexAbility sensor-enabled ablation cath
Abbott (NYSE:ABT) said today it won FDA approval for its sensor-enabled FlexAbility ablation catheter designed for cardiac ablation procedures to treat atrial flutter. The sensor-enabled FlexAbility ablation catheter is the Abbott Park, Ill.-based company’s 1st designed to collect electrical current resistance and magnetic data to produce accurate mapping and assist in treating sites that trigger […]
Gamida Cell touts first patient treated in Phase III NiCord trial
Gamida Cell said today that the 1st patient has been treated in the Phase III registration trial of its NiCord cell graft for patients with blood cancer. The treatment is a graft derived from umbilical cord blood which has been expanded and enriched with stem and progenitor cells, according to the company. The Jerusalem-based company’s cell […]
FDA asks Titan for more info before clinical trial of ropinirole implant
Titan Pharmaceuticals (NSDQ:TTNP) said today that the FDA put a hold on the clinical trial of its ropinirole implant and told the company to submit more information to the federal watchdog. After it completed an initial review of the implant’s Investigational New Drug application, the FDA asked Titan for final release test data on its ropinirole […]
Philips wins FDA clearance for ElastQ liver imaging tech
Royal Philips (NYSE:PHG) said today that it won 510(k) clearance from the FDA for its ElastQ imaging technology, which allows for simultaneous imaging and assessment of tissue stiffness to diagnose liver conditions such as hepatitis B and cirrhosis. The company’s technology uses shear wave elastography to focus sound waves and assess soft tissue stiffness, according […]
ViewRay wins 510(k) for MRIdian Linac system, touts Q4, FY2016 prelim results
ViewRay (NSDQ:VRAY) today announced it won FDA 510(k) clearance for its MRIdian Linac system, and released its preliminary earnings for the 4th quarter and full fiscal year 2016. The newly cleared MRIdian Linac device replaces the cobalt it utilized with linear accelerator technology, the Cleveland, Ohio-based company said. “FDA clearance of the MRIdian Linac is a transformative milestone […]
Velano Vascular wins FDA 510(k) for Pivo needle-free blood draw device
Velano Vascular said today it won FDA 510(k) clearance for its Pivo needle-free vascular access device designed for drawing blood. The San Francisco, Calif.-based company said its Pivo is a single-use disposable device designed to take blood samples from indwelling peripheral IV lines to reduce the amount of needle sticks and central line acces for blood […]
AV Medical wins expanded FDA 510(k) for Chameleon PTA balloon cath
AV Medical Technologies said today it won expanded FDA 510(k) clearance for its Chameleon PTA balloon catheter designed for the infusion of diagnostic or therapeutic fluids. The Chameleon is designed to allow operators to inject diagnostic or therapeutic fluids through the catheter during procedures, whether the balloon is inflated or deflated and while maintaining wire […]
FDA green-lights Cagent Vascular’s Serranator Alto PAD balloon catheter
Cagent Vascular said today that it won 510(k) clearance from the FDA for its Serranator Alto balloon catheter, which is designed to treat peripheral artery disease. The Wayne, Pa.-based company bills its serration technology, created by co-founder and CMO Dr. Peter Schneider, as a way to improve arterial expansion during balloon angioplasty for PAD. The device’s […]
OncoSec wins fast track designation for electroporation combo therapy
OncoSec Medical (NSDQ:ONCS) said today that it won Fast Track Designation from the FDA for its ImmunoPulse IL-12 electroporation gene therapy for the treatment of metastatic melanoma. The biotech company’s electroporation device is designed to locally deliver DNA-based interleukin-12 to stimulate the immune system and fight off cancer cells. The ImmunoPulse device delivers a sequence […]
FDA accepts AcelRx’s NDA for Dsuvia pain reliever
AcelRx Pharmaceuticals (NSDQ:ACRX) said today that the FDA accepted the company’s New Drug Application for its Dsuvia pain relief therapy. The federal watchdog set a target decision date for October 12 this year. The company’s Dsuvia candidate is composed of 30 sufentanil tablets delivered sublingually using a disposable, pre-filled single-dose applicator to patients with moderate-to-severe […]