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 System, which uses extreme cold to treat cardiac arrhythmias. The news came two days before CryoCor was scheduled to present clinical data...

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 a court order signed last Friday, Shelhigh is required to hire independent consultants to inspect its facility and certify to FDA...

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 focused on women’s health, for $70 million. Of utmost importance to the acquisition for Hologic is BioLucent’s MammoPad...

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 billion portfolio. On September 19, FDA’s Circulatory System Devices Advisory Panel will review SyntheMed’s pre-market approval application for REPEL-CV...

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. With milestone payments, the agreement could reach $30 million in value. ATS will pay $22 million in cash at...

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 determining candidacy for implantable defibrillators. Under the amended terms, St. Jude will be able to market Cambridge Heart’s HearTwave II Microvolt...

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 to self monitor their glucose levels without having to penetrate the skin. It’s targeted at patients with demanding need for...

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 over the weekend in the Milwaukee Journal Sentinel. “The reason they work is they’re very steady in their performance, and...