Remove FDA Remove Food Remove Physicians Remove Sales
article thumbnail

Is it too late for Biogen?

World of DTC Marketing

Biogen will partner with Roche on the development, and potential sale of a promising cancer drug the Swiss pharma is advancing for several types of lymphoma, announcing Tuesday it’s exercised an option to share rights to the treatment. Food and Drug Administration on Biogen Inc.’s Top researchers who advised the U.S.

article thumbnail

FemDx Medsystems, Inc. Receives FDA Clearance For Its FalloView™ Falloposcope

Legacy MEDSearch

Food and Drug Administration (FDA) 510(k) clearance for its FalloView device. The LCD screen on the handle of the device allows the physician to visualize internal patient anatomy in line with instrument insertion. Food and Drug Administration (FDA) 510(k) clearance for its FalloView device. Are you hiring?

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

Techsomed Announces FDA Clearance for Ablation Treatment Planning and Confirmation Software

Legacy MEDSearch

a medical software innovator dedicated to enhancing clinical impact in ablation therapy, announced today that it has received 510(k) clearance from the USA Food and Drug Administration (FDA) for its VisAble.IO solution is not yet approved for sale or distribution in the USA and is limited by USA law to investigational use.

FDA 52
article thumbnail

Orlucent Receives FDA Breakthrough Device Designation for Handheld Mole Imaging System

Legacy MEDSearch

Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the company’s Orlucent® Skin Fluorescence Imaging System. The designation allows a collaborative and streamlined review pathway with FDA so the Orlucent technology can get to the market faster. Orlucent, Inc., president of Orlucent.

FDA 52
article thumbnail

FDA greenlights Boston Scientific’s Novel Drug-Coated Balloon for Coronary In-Stent Restenosis

Legacy MEDSearch

Food and Drug Administration (FDA) for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease. physicians the opportunity to treat their patients with this novel device.” Boston Scientific’s AGENT Drug-Coated Balloon (DCB) has been granted approval by the U.S. Are you hiring?

article thumbnail

EndoStim Receives FDA Breakthrough Device Designation for the EndoStim System for the Treatment of Drug Refractory GERD

Legacy MEDSearch

Food and Drug Administration (FDA) granted Breakthrough Device Designation for the Company’s EndoStim System. “We are pleased that the FDA has recognized the therapeutic potential of the EndoStim System as a new treatment in development for drug refractory GERD,” said Eric Goorno, Chief Executive Officer of EndoStim. .

article thumbnail

FDA Expands Indications for Use of FibroScan® for Comprehensive Liver Management

Legacy MEDSearch

Food and Drug Administration (FDA) has cleared expanded Indications for Use for screening with FibroScan® , the non-invasive liver management technology by Echosens. Measurement interpretation has been expanded to all physicians with appropriate training.