Briefs
FDA Adds MedExel to Import Alert List
The FDA has banned South-Korea based MedExel Medical Manufacturing from importing its products into the U.S., after the company refused an FDA foreign establishment inspection. MedExel has manufactured insulin injection, pen needle and insulin pump products since 2000, according to the company’s website. The company could not be reached for comment by press time. Read the import alert here: www.fdanews.com/03-16-FDAImportAlert.pdf.
Boston Scientific’s Offices Raided in Brazil
Brazil’s Administrative Council of Economic Defense raided the offices of a Boston Scientific subsidiary on Dec. 1, 2015, as part of an investigation into alleged anti-competitive activity with respect to certain tender offers for government contracts, the company says in a Securities and Exchange Commission filing. Several other major devicemakers doing business in Brazil were also raided. Read the SEC filing here: www.fdanews.com/03-16-BSXSEC.pdf.
EOS Imaging Gains CE Mark for spineEOS
Paris-based EOS imaging has won CE Mark certification for spineEOS, the company has announced. The online 3D planning software for spine surgery relies on EOS bi-planar imaging to create treatment plans focused on achieving sagittal alignment in patients with Adolescent Idiopathic Scoliosis or degenerative or deformative spine conditions. It offers treatment simulation based on reference values, taking into account the patient vertebrae shape and position in 3D. The software is currently being used in clinical studies in Paris, France and San Diego, Calif.
Health Canada OKs BBI’s SEM Scanner
Health Canada has awarded Bruin Biometrics — developer of sensor-based diagnostic products — with a Medical Device License for its SEM Scanner to detect pressure ulcers. The scanner is the first handheld device that can pinpoint pressure-induced tissue damage before visual signs of skin ulceration appear, the company says. BBI also has completed a three-year distribution agreement for the SEM Scanner with The Stevens Company.
Quest Diagnostics Finalizes Acquisition
Quest Diagnostics has successfully completed its acquisition of Clinical Laboratory Partners, an outreach laboratory service business and subdivision of Hartford HealthCare. Financial terms were not disclosed. The acquisition will give patients and providers in Connecticut “a broader network of patient service centers and three rapid-response clinical laboratories in the state,” the company says.
NanoString to Collaborate With Merck
Pharmaceutical giant Merck & Co., has reached an agreement with Seattle-based NanoString Technologies to develop and market a test to predict response to Keytruda, a PD-1 inhibitor. The agreement tasks NanoString with seeking regulatory approval and commercialization of the diagnostic test, which depends on selected gene expression signature to predict patient response to Kyetruda in multiple tumor types. In return, NanoString will be eligible to receive up to $24 million for technology access and short-term milestones. Additionally, NanoString will receive development funding and other potential regulatory milestone payments.