FDA Gives CryoCor the Cold Shoulder
San Diego-based CryoCor suffered a blow today, when it learned that FDA is yet again unhappy with the company’s pre-market approval application for its Cryoblation […]
Shelhigh Consent Agreement Stops Short of Recall
Shelhigh has agreed to stop distributing its implantable devices, roughly two months after FDA seized products made at the company’s Union, NJ, manufacturing facility. Under […]
BioLucent Acquired by Hologic for $70 Million
BioLucent, a Aliso Viejo, CA-based company that makes breast cushions for increased comfort during mammographies, has been scooped up by Hologic, a diagnostic imaging company […]
FDA Panel to Review Device that Prevents Scar Tissue
SyntheMed, of Iselin, NJ, today got word that an FDA panel will advance the first anti-adhesion product in what the company estimates is a $2 […]
ATS to Acquire Surgical Cryoblation Biz from CryoCath
Minneapolis-based ATS Medical has agreed to acquire the surgical cryoablation business of CryoCath Technologies, a Canadian company that will now focus exclusively on electrophysiology cryoablation. […]
Amended Agreement Expands Cambridge Heart’s Reach
Cambridge Heart, of Bedford, MA, has amended its marketing agreement with St. Jude Medical in a way that could significantly expand access to tests for […]
Non-Invasive Glucose Monitor Cleared in Europe
OrSense, a privately held Israeli company, has been cleared in Europe to market its first product, a first-in-class, non-invasive glucose monitor. The NBM-200G allows diabetics […]
Molecular Diagnostics Have Edge in Med Tech Sector
Companies developing molecular and specialty diagnostics are poised to outperform other sectors of medical technology in the coming years, according to an article that ran […]
Seeking Partners for Melanoma-Detection Device
With its final pivotal trial moving along as planned, Irvington, NY-based Electro-Optical Sciences is actively initiating partnering discussions for its point-of-case melanoma-detection device. MelaFind is […]
FDA Clears Thumb Implant for Osteoarthritis
Small Bone Innovations (SBi), a New York, NY, company focused exclusively on small bone and joint orthopedic devices, has received FDA clearance to market a […]