TDC Medical expands California facility
TDC Medical(Marlborough, Massachusetts) reports the expansion of its Cleanroom at its facility in Sunnyvale, California. The Controlled Environment area is now approximately 1,000 square feet The room is certified ISO Class 8 per ISO 14644-1. This Class 8 Cleanroom will be used to support the design and development of innovative medical devices and clinical product.
The upgrade is part of TDC Medical's total commitment to providing exceptional products and service and will further increase TDC Medical's clinical output capability. This is a significant initiative in our constant efforts to provide unparalleled product development solutions, while still maintaining a cost-effective service and providing high levels of customer satisfaction to our clients.
TDC Medical provides services for the creation and production of disposable and therapeutic medical devices.
Mediware consolidates into single entity
Mediware Information Systems (Lenexa, Kansas) said that it completed the consolidation of its three business units into a single corporate structure.
Mediware’s divisions have historically operated as separate entities, with redundant business functions across each operation. This consolidation of operations and elimination of redundant business functions was initiated two years ago by Mediware’s management team under the direction of outgoing CEO James Burgess, the company said.
As a result of the consolidation, Mediware expects to benefit from reduced costs and lower corporate overhead. The savings will result primarily from the closing of a small office and the reduction of about 20 employees, a significant portion of whom were in the perioperative management division. The resulting savings and efficiencies are expected to accelerate the growth of the company’s two primary product lines, which are focused on closed loop clinical systems for blood and medication management.
Mediware’s plans for the future include a stronger focus on areas of healthcare where the company’s products can support a closed loop clinical process to provide patient safety and operational efficiency improvements.
The company’s medication management products have provided for this capability, from order entry to pharmacy fulfillment and medication administration. The recent launch of Mediware’s BloodSafe for transfusion administration extends the company’s blood management capability from the blood bank to bedside administration. Perioperative management customers will continue to be supported; however, the company said it no longer intends to invest in marketing, sales or growth in this area.
Mediware delivers blood and medication management software systems that encapsulate information supporting patient therapies, reinforce patient safety practices and improve efficiencies to lower costs, the company said.
Encision receives Amex warning letter
Encision (Boulder, Colorado), a company specializing in minimally-invasive surgery products, said that it received a notice letter from the American Stock Exchange (Amex) that Encision did not satisfy a rule for continued listing on the Amex.
The notice letter serves as a warning letter and asserts that the company failed to comply with the requirements of Section 1003(a)(ii) of the Amex company guide, which failure could jeopardize the company’s continued listing on the Amex. Section 1003(a)(ii) of the Amex Guide requires, among other things, that an issuer have stockholders’ equity of not less than $4 million if such issuer has sustained losses from continuing operations and/or net losses in three out of its four most recent fiscal years.
ReBuilder Medical cleared for Pink Sheets listing
ReBuilder Medical Technologies (Charles Town, West Virginia) said that its securities have been cleared for public quotation on the Pink Sheets under the symbol RBRM.
ReBuilder Medical’s flagship product is its FDA registered, ReBuilder System for treating peripheral neuropathy. Unlike current therapies for neuropathy (nerve disease) which focus on prescription drugs with powerful side effects, the ReBuilder System is a portable, battery-powered medical device that provides a new non-surgical treatment which is non-invasive, has no side effects and can actually strengthen muscles while increasing blood flow, the company said.
More than 20,000 patients have been treated using the technology of the ReBuilder System. It has a success rate that tops 95% and treats the cause as well as the symptoms. The treatment can be self-administered for less than $1.00 a day.
Medwave now quoted on Pink Sheets
Medwave (Arden Hills, Minnesota) reported that shares of its common stock will be quoted on the Pink Sheets, rather than the OTC Bulletin Board.
As previously reported (Medical Device Daily, July 13, 2007), because the company’s common stock had fallen below the NASDAQ capital market’s minimum bid price standard for continued listing, NASDAQ notified the company of its decision to suspend trading effective at the opening of business on July 17. Medwave develops sensor-based non-invasive blood pressure solutions.
New guide focuses on coagulometers
Coagulometers are used in clinical laboratories for the common screening tests including prothrombin time, activated partial thromboplastin time, thrombin clotting time, and Clauss fibrinogen assay.
Some analyzers may also have the capability to perform chemiluminescent assays. With newer trends in hemostasis testing and tailored reagent/instrument manufacturing, there is a need for a more holistic outlook to instrument evaluation prior to use for patient testing samples.
In response to this need, Clinical and Laboratory Standards Institute (CLSI; Wayne, Pennsylvania) has published a new document, “Protocol for the Evaluation, Validation, and Implementation of Coagulometers; Proposed Guideline (H57-P),” which specifies recommendations on how to plan and execute the selection, evaluation, validation, and implementation of a laboratory coagulometer.
It includes assessment of safety, carryover, precision, bias, linearity, and comparability for coagulometers that perform clotting, chromogenic and/or immunoturbidometric and/or chemiluminescent testing.