More than three-quarters of the cost to bring a medical device from concept to the U.S. market is spent clearing regulatory hurdles, according to a Stanford University report.
News Well
Genzyme dumps diagnostics biz for $265 million
Genzyme Corp. (NSDQ:GENZ) is planning to sell off its diagnostics business to Tokyo-based Sekisui Chemical Co. Ltd. (TYO:4204) for $265 million in cash.
The Cambridge, Mass.-based biotech giant said Sekisui will buy "substantially all of the assets" of the unit and agreed to offer its approximately 575 employees jobs when the deal is closed. The Japanese firm also plans to maintain operations in all of the business’s current locations, according to Genzyme.
Vycor picks up NovaVision assets
Vycor Medical Inc. (OTC:VYCO) bought up the assets of vision restoration therapy company NovaVision Inc. and its German subsidiary for $900,000.
Bohemia, N.Y.-based Vycor makes neurosurgery retraction devices. With NovaVisions’ assets, it picks up technology designed to treat vision loss from stoke or brain injury.
BioDiogics and Predictive Biosciences ink licensing, distribution deals
Amedica/US Spine and Predictive Biosciences announced licensing and distribution deals with a pair of other companies.
Salt Lake City-based spinal reconstruction implant maker Amedica/US Spine intends to distribute spinal fusion, adhesion barrier and nerve protection products based on BioDlogics’ human cellular and tissue-based products, or allografts.
Imaging software developer Orasi Medical drums up $1.8 million
University of Minnesota-spinoff Orasi Medical Inc. raised $1.8 million from the sale of equity, according to a Securities & Exchange Commission filing.
Overall, the software startup hopes to raise $2.6 million by December.
CEO Shawn Lyndon declined to comment, citing SEC rules that prohibit public comments on fundraising activities.
The company, which generates less than $1 million a year in revenue, is developing software designed to help pharmaceuticals makers speed the development of drugs targeting neurological diseases, like Alzheimer’s.
Radisphere raises $27.5 million
Radiology outsourcing firm Radisphere National Radiology Group Inc. raised $27.5 million in an equity-based Series C investment round, according to a Securities & Exchange Commission filing.
The company will use the funding to invest in its “radii” technology platform, CEO Scott Seidelmann said in a statement.
Weekly Wireless Roundup: A microchip a day might keep the doctor away
A microchip a day might keep the doctor away: Novartis AG, using technology licensed from Proteus Biomedical, is currently developing the Ingestible Event Marker, a specialized microchip which the company plans to add to pills. When a patient ingests an IEM-enhanced pill, their stomach acids activate the microchip, which then sends data such as heart rate, temperature, and body movements to a dermal patch via Bluetooth connectivity. This patch can then export the data to an EMR, so that it can be accessed by the patient’s doctors.
Vote forestalls GOP grilling of Medicare head Berwick
The much-anticipated grilling of Medicare chief Dr. Donald Berwick by Senate Republicans was cut short by a scheduled vote, prompting one senator to call the hearing "pathetic."
FDA keeps Medtronic waiting on pacemakers
Certain pacemakers and implantable defibrillators made by Medtronic Inc. (NYSE:MDT) can’t be sold in the U.S., but the company can’t figure out why.
The Fridley, Minn.-based company received a warning letter from the Food & Drug Administration a year ago, regarding the devices’ manufacture, that’s still blocking their sale.
Three rules for using DiSC assessments at work
By Eileen Sarson
The story
The day after I facilitated a workshop on communication styles and the use of DiSC theory to sort it all out, a woman from the class came up to me and said, “I have a story to tell you.”
Clearances roundup: Medtronic’s Physio-Control wins 510(k) for LifeNet 5.0 data network
Here’s a roundup of companies announcing clearances and approvals from the Food & Drug Administration and foreign regulatory agencies: