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 […]
Articles by Sara Calabro
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 […]
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. […]
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 […]
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 […]
NeuroVasx Submits 501(k) for Cerebral Aneurysm Device
NeuroVasx, a Maple Grove, MN, company that makes devices for hemorrhagic and ischemic stroke, has submitted a 510(k) application for a new device that treats […]
Sontra Medical Closes $1 Million Financing
Sontra Medical Corporation, a Franklin, MA company focused on transdermal drug delivery and diagnosis, has closed $1 million in financing. Internal sources — a board […]
Up Next: Nicotine Replacement Devices
Next Safety, a West Jefferson, NC, company that makes respirators, is now using its technology to develop pulmonary drug delivery and nicotine replacement devices. The […]