• Howard Leight (Smithfield, Rhode Island) has introduced QuietDose – a personal dosimeter that measures and records a worker's actual in-ear exposure to noise over an entire work shift. The product is designed towards stopping the progression of occupational hearing loss and ensuring employer compliance with hearing safety regulations. The QuietDose system consists of a small Exposure Smart Protector (ESP) Dosimeter that's worn by employees in a shirt pocket or on the back of a hardhat; protective eartips or an earmuff with integrated microphones that record real-time in-ear noise levels; and a connecting harness. An infrared reader enables safety managers to retrieve data from the ESP Dosimeter at the end of each shift or work week and analyze the results on a personal computer.

• Instrumentation Laboratory (IL; Bedford, Massachusetts) said it received FDA clearance for the ACL AcuStar Hemostasis Testing system. IL says the ACL AcuStar is the first specialty-test analyzer that offers full automation of highly sensitive immunoassays for the hemostasis lab. Labor-intensive specialty tests that previously required specialized training and up to two hours to perform, can now be performed in as little as 25 minutes, with no special training required. The AcuStar uses chemiluminescence technology, broadly considered the most accurate and sensitive method for routine immunoassay testing.

• Jubilant Organosys (Noida, India) said that its subsidiary in the U.S., Draximage, has received FDA approval for the company's Abbreviated New Drug Application (ANDA) for Draximage's generic Sestamibi. The product is found to be bioequivalent and therapeutically equivalent to reference listed drug Cardiolite. The Sestamibi is a generic kit used in the preparation of Technetium (Tc-99m) Sestamibi injection – a diagnostic cardiac imaging agent used in myocardial perfusion imaging to evaluate the flow of blood to the heart.

• Orthofix International (Boston) said it has begun the limited market release of Trinity Evolution in collaboration with the Musculoskeletal Transplant Foundation (MTF). Trinity Evolution is a stem cell-based bone growth matrix designed to advance the surgical use of allografts by providing characteristics similar to an autograft in spinal and orthopedic procedures. Trinity Evolution is used by surgeons to facilitate bone fusion, and will be marketed exclusively by Orthofix Spinal Implants and Orthofix Orthopedics. MTF is responsible for the recovery of donor tissue, the processing of the bone growth matrix, and for the fulfilment of orders received.