Hiemstra Product Development (San Francisco), a product design and development company, said that it has received Food and Drug Branch (FDB) approval from the California Department of Health Services’ Division of Food, Drug and Radiation Safety to manufacture class I-III medical devices in its 750-square-foot, class 10,000 CER (clean room).
This approval enables Hiemstra to be a manufacturing resource for customers through first-in-man, ongoing clinical trials, and low- to mid-volume production needs during early ramp-up or as ongoing manufacturing support.
A few examples of the types of devices that Hiemstra's CER can support are implants, surgical tools, catheters and catheter-based delivery systems.
HealthCare Technologies receives Nasdaq notice
HealthCare Technologies (New York) said that it received a letter from the staff of the listing qualifications department of Nasdaq, which indicated that because the staff believes that the company’s Plan of Arrangement with NexGen Biofuels constituted a reverse merger, the surviving entity is required to submit an initial listing application and satisfy Nasdaq’s initial listing standards. On Sept. 7, 2007, NexGen Biofuels, submitted its listing application.
However, the application was not approved because, among other things, the company did not meet the minimum $4 bid price requirement for initial listing. Accordingly, the company's securities will be delisted from Nasdaq. In that regard, unless the company requests an appeal of this determination, Nasdaq will suspend trading of the company's securities on the Capital Market at the opening of business on Jan. 16.
DePuy Orthopedics certifies sales team
DePuy Orthopaedics (Warsaw, Indiana) said that more than 700 of its sales representatives have completed a certified and accredited sales training program in orthopaedics, the first such program in the industry.
DePuy is the first orthopaedic device manufacturer to require its sales representatives to earn continuing education credits in subject areas, including anatomy and biomechanics, orthopaedic products, HIPAA policies, patient rights, infectious disease prevention and operating room and hospital protocols. Courses are taught by health professionals and other experts, including orthopaedic surgeons, nurses, engineers and product specialists.
“DePuy Orthopaedics is committed to providing its customers with the most highly trained sales professionals in the industry,” said Rob Chambers, DePuy Orthopaedics Vice President of Sales. “This program ensures that our sales representatives are educated on the issues that are important to our customers and their patients.”
DePuy Orthopaedics makes orthopaedic devices and supplies including hip, knee, extremity, trauma, cement, orthobiologics, and operating room products.