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June 20 - June 26th

June 20th: Aksys Receives FDA Warning Letter

Aksys®, Ltd, a pioneer in innovative dialysis systems, today announced that it received a warning letter dated June 8, 2006 from the United States Food and Drug Administration (FDA).

The letter references the marketing of the Company's Personal Hemodialysis (PHD®) System with a modified treatment length that exceeds the treatment length provided in the Company's premarket 510(k) notification for the PHD System, which was cleared by the FDA on March 26, 2002. Aksys is committed to working cooperatively and expeditiously with the FDA in order to resolve the matters raised in the FDA letter and is undertaking a review of other modifications made to the PHD System since March 2002 in light of this letter.

Aksys, Ltd. produces hemodialysis products, providing services for patients suffering from kidney failure. The Company's lead product, the PHD® System, is a currently available, advanced technology hemodialysis system designed to improve clinical outcomes of patients and reduce mortality, morbidity and the associated high cost of patient care.

June 21st: Devon Medical Receives FDA Clearance for SharpShield(TM) Safety Syringe

Devon Medical, a leading developer and manufacturer of innovative medical products, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its safety-engineered SharpShield(TM) syringe.

SharpShield allows true single-hand injection requiring virtually no change in standard techniques. The safety device passively activates subepidermally when a form-fitted sheath slides over the needlepoint after the medicine is administered. This occurs before the needle is removed from the patient preventing exposure to the contaminated needle. The plunger locks to ensure one-time use and low dead space. Unlike auto-retractable syringes, SharpShield does not cause blood splatter upon activation or removal.

Statistics from the Centers for Disease Control and Prevention (CDC) show that nearly one million U.S. healthcare workers suffer accidental needlestick injuries every year, not including as much as 90% of cases that go unreported, causing the occupational transmission of more than 20 blood-borne pathogens and other infectious agents. According to the World Health Organization (WHO), 40% of Hepatitis B and C infections and 2.5% of HIV/AIDS infections among healthcare workers are attributed to accidental stick injuries.

June 26th: Abbott Receives FDA Approval for New HUMIRA(R) Delivery Device

Abbott announced today that the U.S. Food and Drug Administration (FDA) approved the HUMIRA Pen, a new device for administering HUMIRA® (adalimumab), a treatment approved for moderate to severe rheumatoid arthritis (RA) and psoriatic arthritis .With its one-touch activation and easy-to-grasp size and shape, the HUMIRA Pen offers improved ease of use for these patients, many of whom may have swelling or stiffness in the hands. The HUMIRA Pen has a needle that is not visible during the injection process, and this device provides a less painful experience for some patients. Patients place the HUMIRA Pen against the skin, press a button, and wait for the medicine to inject. The HUMIRA Pen will be available to U.S. patients beginning in August.

Currently, HUMIRA is taken as a subcutaneous injection (injection beneath the kin) via a specially designed prefilled syringe. HUMIRA is currently indicated for moderate to severe rheumatoid arthritis and for active arthritis in patients with psoriatic arthritis and is being studied as a possible treatment for other autoimmune diseases.

In results of the TOUCH (Trial Of Usability in Clinical settings of HUMIRA Autoinjector vs. Prefilled Syringe) study, which included 52 HUMIRA prefilled syringe patients, approximately nine out of 10 preferred the new HUMIRA Pen, rating it more convenient and easier to use, while approximately eight out of 10 found it to be less painful.

Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs 65,000 people and markets its products in more than 130 countries.

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