Medtronic Alleges Patent Infringement by NuVasive

Device giant Medtronic Sofamor Danek has filed a complaint against NuVasive, alleging patent infringement by certain NuVasive products. Nuvasive is in the process of reviewing the complaint and assessing its defenses. Based on an initial review, Alex Lukianov, the company’s Chairman and CEO, does not...

Predicting the End of PreMD: FDA Rejects PREVU 510(k)

The FDA has upheld its decision regarding PreMD’s not substantially equivalent letter received in connection with the company’s 510(k) submission for an expanded regulatory claim on its skin cholesterol test. PreMD submitted the 510(k) this June seeking to obtain broader clearance for the assessment of...

Session Summary & Overview 5:30

CFO as Enterprise Risk Management Leader: How financial executives add value to this critical process Enterprise risk management (ERM) has the ability to help medical device companies align people, processes and ideas which support corporate objectives, improve cash flow and earnings, capture...

Nanogen and The Elitech Group to Merge

Nanogen, a molecular and point-of-care diagnostics company, will merge with The Elitech Group, a private French diagnostics company. Elitech has been on a tear of late. In 2007, the company acquired Wescor and Vital Scientific. Elitech offers clinical chemistry, microbiology, immunology and electrophoresis...

[Video Profile] Interview with Harry Stylli, President & CEO of Sequenom

Sequenom’s MassARRAY system is a DNA analysis platform that measures the amount of genetic target material and variations therein. MassARRAY delivers reliable and specific data from biological samples and from genetic target material that is only available in trace amounts. With MassARRAY, Sequenom...

After a Weak Second Quarter, Ophthalmic Imaging Systems Eyes EMR Business

It’s been tough going for Ophthalmic Imaging Systems (OIS). The digital imaging company reported second quarter net revenues of $3.2 million, compared with net revenues of $3.6 million for the same period last year. The company lost $249,000 in the second quarter of 2008. In its second quarter last year,...

Inovio Biomedical Extends Agreement with the Internation AIDS Vaccine Initiative

Seth Berkley, head of the IAVI or International AIDS Vaccine Initiative (a not-for-profit developing preventive HIV vaccines) believes the majority of HIV vaccines now under development need to be abandoned. These vaccines tweak cell-based immunity, a strategy first explored by Merck. Berkley wants to focus...

American Medical Alert Builds Defensible, Recurring Revenue Stream

American Medical Alert (AMAC), developer of Ready Response, which aids the elderly when they fall and can’t get up, announced strong Q2 performance this week. Second quarter revenues were $9.5 million, a 7% increase over the same period last year. Net income also increased, growing to $458,026, a 12%...