Hong Kong’s government currently does not strictly regulate most medical devices. However, in late August 2010, Hong Kong’s Medical Device Control Office proposed a framework for comprehensive and mandatory regulation of medical devices and in-vitro diagnostic medical devices. The new framework draws significantly from the Global Harmonization Task Force (GHTF) and the World Health Organization (WHO). Companies dealing with medical devices in Hong Kong should begin preparations for these upcoming regulations.
News Well
Clinical trials roundup
Here’s a roundup of recent clinical trial news:
Battelle launches IP database
Need a Deep Web Miner to retrieve hard-to-find life sciences research?
How about a cell therapy manufacturing system?
Then Battelle might have the intellectual property for you.
EndoRetics looks cash in on weight loss
With an estimated 300 million clinically obese people on the planet, companies that are looking to help ease that epidemic will likely have no shortage of customers.
Mobi looks to move crutches on Facebook, Twitter
Facebook, Twitter and all other things social media are a tougher sell in the HIPAA-filled world of healthcare. Companies want a piece of that world (they think), but it’s harder to find a fit, and eventually, a return on investment in health than in a field like consumer technology.
Feds force Synthes to sell Norian, pay $23 million in fines
Synthes Inc., the American division of the Swiss medical device maker, will plead guilty to federal criminal charges that its North American subsidiary Norian Corp. made an illegal end run around the Food & Drug Administration for clinical trials in which three patients died.
Argon buys critical care and catheter platforms from BD
Argon Medical Devices Inc. bought pressure monitoring and catheter product lines from the medical device sector of Franklin Lake, N.J.-based Becton, Dickinson & Co. (NYSE:BDX).
The acquisition comprised BD’s blood pressure monitoring devices and central venous, pulmonary artery and extended dwell catheters forAthens, Texas-based Argon. The deal expands its interventional radiology, critical care and cardiac catheterization product lines.
EarlySense lands FDA OK for patient data central display
Israeli medical device company EarlySense Ltd. announced today that its EverOn Central Display Station — which accompanies its EverOn Touch patient monitoring system — was cleared the Food & Drug Administration.
The 510(k) clearance covers the ability to collect real-time vital sign information from up to three dozen EverOn bedside monitors and display the information on a computer screen at a nurse’s station. The information also is displayed on large LCDs on medical or surgical floors, enabling clinicians to continuously monitor patients.
Patrick: Gift ban never meant for medical devices
Massachusetts Gov. Deval Patrick said today at a gubernatorial debate hosted by the Mass. Biotechnology Council that the Commonwealth’s so-called "gift ban" wasn’t intended to include the medical device industry and vowed that he would re-tailor the law for drug companies.
"As a practical matter," Patrick said, his administration found that the gift ban reaches beyond the drug industry and that he doesn’t believe it was the law’s original "intent" to do so.
"Aligning it with pharma is a priority of mine," Patrick said.
Zen and the art of product maintenance
Taking a break during a recent business trip in Japan, we were sitting in the rock garden of Ryoanji, a Rinzai Zen temple in Kyoto. Created in the 15th century, Ryoanji boasts one of the world’s most famous Zen gardens; its 15 stones are positioned so that two or three are always hidden from view. The lesson is that no one is ever able to see everything all at once. There is always more than — literally — meets the eye.
Hirooka-san, our guide and a self-described Buddhist, explained this to us and then asked me, "So … are you enlightened?"
"I understand now why this garden is so special," I offered.
Children’s Hospital Boston spins out ModeRNA Therapeutics
Hot on the heels of the announcement of a revolutionary method of creating stem cells without destroying human embryos, the Harvard researchers who discovered the technique are spinning out a company to commercialize it.
Researchers at Boston’s Harvard Stem Cell Institute discovered a way to reprogram human skin cells so that they become stem cells, bypassing the creation of stem cell lines from human embryos.