A trio of med-tech titans logged a win against Johnson & Johnson (NYSE:JNJ) in a long-running battle over drug-eluting coronary stent patents.
Dental
PRO-DEX, INC. ANNOUNCES FISCAL 2011 FOURTH QUARTER AND FULL-YEAR RESULTS
IRVINE, CA, September 14, 2011 – PRO-DEX, INC. (NasdaqCM: PDEX) today announced financial results for its fiscal fourth
quarter and full-year ended June 30, 2011.
Baxter’s Artiss sealant wins FDA clearance for face-lift procedures | Regulatory Roundup
Baxter International Inc. (NYSE: BAX) won an expanded indication for its Artiss fibrin sealant, making it available for use during in sealing tissue flaps during face-lift surgeries.
Artiss first won FDA clearance in 2008 for use in adhering skin grafts in wound beds prepared for treating burns in adults and children over the age of one.
Health reform hits the highest court
MASSDEVICE ON CALL — Health care reform challengers took their complaints to the Supreme Court for the first time this week, asking the judges to rule on the validity of the individual insurance mandate in President Barack Obama’s health care overhaul.
The Thomas More Law Center, a Michigan-based firm generally focused on promoting religious freedom for Christians, filed a cert petition appealing a 6th Circuit Court of Appeals ruling that the health care overhaul is within constitutional bounds, specifically in regard to the mandate that nearly all Americans buy health insurance.
Biotronik: J&J ran “sham” recall | Legal Roundup
A Johnson & Johnson (NYSE:JNJ) subsidiary allegedly issued a sham recall of its drug-eluting CoStar coronary stent and spiked a distribution deal with Biotronik AG that cost the German medical device giant $100 million, according to a lawsuit filed in New York’s highest court.
Japanese dental school unveils new life-like practice robot with “love doll” skin and mouth
Japan’s Showa University unveiled their latest training dummy, a life-like robot dental patient with a moving head and arms, and facial and oral features that react to pain and fatigue the way a real patient might.
Named Hanako 2, this latest robot incorporates skin, mouth and tongue features built by the country’s top sex doll manufacturer, Orient Industry.
Hanako 2 represents significant improvements over the prior model. It can blink, sneeze, shake its head, cough, gag and engage in simple conversation using voice recognition software.
Report: Consolidation ahead for medical device sector | Acquisitions Roundup
Impending federal excise taxes, downward pricing pressure and declining volumes of big-ticket procedures constitute a triple threat that will drive the medical device industry to consolidate, according to a PricewaterhouseCoopers report.
The total value of health care deals over the past 12 months rose 40 percent, according to the consulting giant’s “U.S. Mid-Year M&A Outlook.” That trend is likely to continue, the report predicts.
Federal marshals seize Fla. company’s dental devices
U.S. marshals seized all the dental devices from a Fla.-based company after a Food & Drug Administration inspection turned up violations in the company’s manufacturing processes.
Acting under court order from the FDA, the marshals on Jan. 5 and 6 removed the products from Hialeah, Fla.-based Rite-Dent Manufacturing Corp., according to the watchdog agency. The seized property is valued at valued at $208,910, the agency said.
MassDevice Podcast: Avedro Inc. CEO David Muller
More than 20 years ago, David Muller led a revolution in the world of vision correction.
As chairman and CEO of Summit Technology, he led a team that brought the first excimer laser through the Food & Drug Administration for use in reshaping the cornea. The technology, later dubbed Lasik, is a worldwide phenomenon and has helped tens of millions of patients shed glasses and contact lenses.
Decades later, Muller is at it again as the chief executive of Waltham, Mass.-based Avedro Inc., looking to finish what he started, this time with a new vision correction procedure he says will make Lasik safer and more effective.
Riverside buys orthodontics supplier
Leveraged buyout company The Riverside Co. purchased an Indiana-based maker of orthodontics equipment.
A statement from Riverside didn’t reveal the purchase price for Franklin-based G&H Wire Co. G&H sells springs, wires, bonding products and other orthodontics equipment. The company operates out of a single facility that’s used for production and distribution, as well as a corporate office.
FDA takes another look at mercury-based dental fillings
Last year the Food & Drug Administration ruled that the mercury-containing metal in dental fillings is safe, but the agency wants to know if the methods it used to determine the alloy’s safety were satisfactory.
The FDA is holding a public meeting today and tomorrow on the issue, focusing on the risk of the dental amalgam for children and pregnant women.