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On July 17 Cambrex Bio Science Walkersville, Md., a subsidiary of Cambrex and Ortec International, announced that it submitted a humanitarian device exemption (HDE) application to the FDA requesting approval to market cryopreserved OrCel for the treatment of a congenital skin disorder.
The FDA said in the July 14 issue of the Federal Register that it is denying the petitions submitted by IM Systems to reclassify the SleepCheck, the ActiTrac and PAM-RL devices from Class II (special controls) to Class I (general controls).
A recent guidance issued by the Centers for Medicare & Medicaid (CMS) has industry groups worrying whether reimbursements for their products could be cut -- or even eliminated.
Acacia Research Corporation announced today that its CombiMatrix group, working in partnership with Furuno Electric Co., Ltd. of Japan, has launched its new QuadroCAS CustomArray Synthesizer.
Merit Medical Systems Inc., a leading manufacturer and marketer of proprietary disposable accessories used primarily in cardiology and radiology procedures, announced today thatit has received the CE mark from its notified body to market the Impress catheter
in Europe.
Today, 20/20 GeneSystems, Inc. ("20/20") announced study results that show that its multi-biomarker blood test may be able to detect non-small cell lung cancer (NSCLC) significantly earlier and with better accuracy than CT scans, the most advanced technique in
current use for detecting this disease.
Medtronic, Inc., today announced that the U.S. Food and Drug Administration (FDA) has approved the Guardian(R) REAL-Time System, a doctor-prescribed continuous glucose monitoring (CGM) system for improved diabetes management.
US medical devices company Palomar Medical Technologies Inc. claims that the laser depilatory device made by Israel's Alma Lasers Ltd. illegally uses Palomar's intellectual property.
Lawmakers are urging the Centers for Medicare & Medicaid (CMS) to delay implementation of proposed changes to the Medicare inpatient prospective payment system that were issued April 12.