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For the fourth year in a row, a medical device company has won the Robert Goldberg
Grand Prize in the MIT $50K Entrepreneurship Competition held at MIT.
CryoLife, a biomaterials and biosurgical device company, announced the first
human implant of its cryopreserved orthopedic tissues utilizing the Clearant
Process.
Helica Plus, a privately held company based in Charlotte, N.C., has signed an
exclusive distribution agreement with Helica Instruments to distribute the patented
Helica Thermal Coagulator (TC) System product line throughout the U.S., Mexico,
Brazil and Central America.
Applied Imaging announced it has received 510(k) clearance from the FDA to market
its Ariol Her-2/neu FISH application, which is designed to detect Her-2/neu
gene amplification in breast cancer biopsy samples via fluorescence in situ
hybridization (FISH).
SomaLogic, a clinical proteomics company, announced that it had entered a technology
development agreement with Quest Diagnostics, a provider of diagnostic testing,
information and services in the U.S.
Xenomics, a developer of next-generation medical DNA technologies, has executed
a contract with North Shore-Long Island Jewish (LIJ) Health System to begin
conducting human clinical studies in the next development phase of the company's
Transrenal-DNA (Tr-DNA) technology.
The FDA has issued a public health notification as a reminder that "serious
injury or death can occur when patients with implanted neurological stimulators
undergo MRI procedures." Doctors and radiology personnel should ask patients
before magnetic resonance imaging (MRI) scans if they have or used to have implanted
neurological stimulators, says the FDA.
OsteoBiologics (OBI), a company specializing in tissue repair technologies,
has received a medical device license (MDL) authorizing the marketing of its
PolyGraft family of products for bone void repair in Canada.