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May 30 – June 5th

May 31st: FDA Clears Boston Scientific System for Removing Clots from Arteries

Boston Scientific Corporation today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market its Rio(TM) Aspiration Catheter, the latest addition to the Company's line of vascular protection devices for minimally invasive procedures. The new device is indicated for use in the removal of thrombi, or clots, from vessels throughout the body.

The Rio Aspiration Catheter can be used with other interventional devices, such as those used to place stents, to open blockages caused by clots in the target area within a vessel. The Rio Aspiration Catheter is comprised of two tubular cavities, or lumens. The primary lumen is used to extract the thrombus. It is open on one end and attached via an extension tube to a 20-cc locking syringe on the other. The syringe is used to apply suction and aspirate the thrombus from the vessel. The second lumen accommodates a guide wire, which is used to move the catheter into position within the target artery. The Rio Aspiration Catheter is compatible with large lumen 6F guide catheters (minimum inner diameter of 0.070 in.). The catheter shaft, which becomes more flexible toward the tip, is designed to help reduce trauma to the vessel and facilitate navigation through tortuous anatomies. A radiopaque marker on the tip further assists in successful maneuvering and placement of the device.

Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties.

May 31st: American Bio Medica Receives FDA Clearance of Its Rapid TOX(TM)

American Bio Medica Corporation today announced that the US Food and Drug Administration (FDA) has granted the Company 510(k) clearance on its Rapid TOX, a cost effective drug screen in a horizontal cassette platform that simultaneously detects two to ten drugs of abuse in a urine specimen. The clearance allows ABMC to provide the Rapid TOX to customers in clinical markets.

Rapid TOX can be used by pipetting, or dropping, a urine specimen into a channel in the cassette, or the cassette can be dipped into a urine specimen. Rapid TOX can also be used with the Company's Rapid Reader(TM); the first FDA-cleared all inclusive drug screen result interpretation and data management system.

American Bio Medica Corporation is a biotechnology company that develops, manufactures and markets accurate, cost-effective immunoassay diagnostic test kits, including some of the world's most effective point of collection tests for drugs of abuse. The Company and its worldwide distribution network target the workplace, government, corrections, clinical and educational markets.

June 1: Regeneration Technologies Receives CE Marks for Sterling(R) Implants Used in Spinal, Sports Medicine, General Orthopedic Surgeries

Regeneration Technologies, Inc. (RTI) the Florida-based processor of orthopedic, cardiovascular and other biologic implants, announced today that the company has received its first CE marks for several Sterling® implants used in spinal, sports medicine and general orthopedic surgeries. These xenograft implants can now be distributed throughout Europe.

The implants receiving the CE mark are: Sterling Cancellous Chips, Sterling Cancellous Cubes, Sterling Suture Anchor, Sterling Interference Screw ST, Sterling Interference Screw HT, Sterling Impacted Cortical Wedge, Sterling Impacted Cortical Ring, Sterling SR, Sterling Machined Dowel and the Sterling HTO Wedge.

To receive these certifications, the Sterling implants were first assessed under the European Medical Device Directive 93/42/EEC Annex II Section 4. Additionally, the implants were required to satisfy TSE Directive 2003/32/EC, a more stringent standard that requires both proof of product safety and demonstration of a clinical need for the product. The addition of Sterling implants to RTI's international distribution allows the company to further tap into a $369.5 million international biologics market. The Sterling implants with the CE mark are available through RTI's international distribution partners.

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