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The researchers say the process is inexpensive and simple, a step toward making the nanowires a more common constituent of electronics, medical devices and solar cells. (Credit: Image courtesy of University of Florida). (Science Daily)
Abbott 2Q profit edges past Wall Street estimates Jul 22, 2010
Abbott Laboratories said Wednesday its net income edged past Wall Street expectations for the second quarter as sales of drugs and medical devices offset increased operational costs. Sales of the company's biotech drugs and artery-opening stents saw double-digit gains, and the company reported higher international sales from its recently acquired Solvay division. (KGW Northwest NewsChannel 8, OR -- Business)
Surprise-Brentwood Industries deal could bring 40 jobs Jul 22, 2010
Phase II would feature a 75,000-square-foot facility for the manufacture or assembly of packaging for medical devices. The facility would be open within 60 months of the effective date, according to the draft agreement. (Phoenix Business Journal, AZ)
Local firm named gateway for med devices Jul 22, 2010
New Product CEO Damon Canfield said in a statement that the latest development now solidifies NPI as the leader in opening up the world s second-largest market for medical devices. The U.S. is the largest market, according to Espicom Business Intelligence. (Columbus Business First, OH)
J&J posts higher 2Q net income despite recalls Jul 21, 2010
Medical devices and diagnostics had a 4 percent increase, but had been growing faster recently. Pharmaceutical sales were up just 1 percent at $5. (KGW Northwest NewsChannel 8, OR -- Business)
Four Triangle companies get NC IDEA grants Jul 20, 2010
BioShape Solutions: a Research Triangle Park company researching medical devices that deliver medicine around surgical implants. The Coaching Mark: a Morrisville company developing online management tools for coaches, athletes and athletic directors. (Triangle Business Journal)
New Black Panthers, You're Free To Go -- Not So Fast, Arizona Jul 20, 2010
Field pre-emption may arise, for example, in the case of federal health and safety laws, so that manufacturers of cars, medical devices and drugs aren't forced to comply with the laws of 50 different states to sell their products nationally. And yet, just over a year ago, the Supreme Court held that there was no "field pre-emption" even in the case of an FDA-approved anti-nausea drug because Congress had not explicitly stated that state regulation was pre-empted. (Human Events Online)
TriPath owner to hire 187 in Johnston County Jul 20, 2010
BD, which makes and sells medical devices, instrument systems and reagents, has its BD Diagnostics-TriPath unit based in Burlington. That facility employs about 100 people who make cervical cancer screening products. (Business Journal of the Greater Triad Area)
How Cranberry Juice Fights Bacteria at the Molecular Level Jul 20, 2010
The research illuminates the basic mechanics of E. coli infections, which has implications for developing new antibiotic drugs and infection-resistant materials for invasive medical devices ... The data may also be useful in studies aimed at engineering the surfaces of invasive medical devices like catheters to make them more resistant to bacterial adhesion. (Science Daily)
Japan OK’s Syneron’s laser system Jul 20, 2010
The company is based in Israel and makes skin treatments and aesthetic medical devices. Copyright 2010 Globe Newspaper Company. (Boston Globe)
After job training, still scrambling for a job Jul 20, 2010
But large-scale manufacturing remains, particularly in one fast-growing industry whose jobs seem unlikely to be shifted overseas: medical devices ... The new program, WorkFast, aimed to quickly prepare laid-off workers for new jobs in medical devices and other growing areas of manufacturing, via intense training units lasting eight to 15 weeks ... But large-scale manufacturing remains, particularly in one fast-growing industry whose jobs seem unlikely to be shifted overseas: medical devices. (Honolulu Star-Bulletin)
Becton Dickinson to create 187 Triangle jobs Jul 20, 2010
Headquartered in New Jersey, BD (NYSE: BDX) is a medical technology company that manufactures and sells medical devices, instrument systems and reagents. Reporter e-mail: lweisbecker@bizjournals. (Triangle Business Journal)
Internet DNA test mix-ups highlight need for regulation Jul 20, 2010
Several weeks later the FDA sent letters to five companies selling tests over the internet, declaring that their kits are medical devices and must undergo federal scrutiny. This week the agency is convening a public hearing to debate what regulatory role it should play. (Sydney Morning Herald -- Technology)
MN companies raised $45M in VC in Q2 Jul 17, 2010
Companies developing medical devices raised the most, with four med-tech firms pulling in $33. 5 million. (Twin Cities Business Journal, MN)
Siemens gets $180,000 state grant Jul 17, 2010
J utions, Inc. of Coralville, a start-up company launched in 2008, manufactures medical devices to help with the safe handling of hazardous medication such as chemotherapeutics used to treat cancer patients. The patent-pending technology is comprised of four disposable devices that attach to standard vials, syringes, intravenious bags and lines. (Keokuk Daily Gate City, IO)
SterilMed sold to private-equity firms Jul 17, 2010
a firm that reprocesses single-use medical devices such as catheters, has been sold to a pair of private-equity firms, the company announced Thursday ... SterilMed collects and cleans single-use medical devices, then returns them to health care providers. (Twin Cities Business Journal, MN)
Medtronic CEO received $9.6M in 2010 Jul 17, 2010
Medtronic, which develops and manufactures medical devices, reported revenue of $15. 8 billion in 2010, up from $14. (Twin Cities Business Journal, MN)
Lady Gaga-Inspired Lens Fad Draws Warning from Eye Docs Jul 16, 2010
All contact lenses are classified as medical devices and can only be distributed through licensed eye care professionals. In its statement, the AAO said it "would like to alert consumers to the hazards of buying any decorative lenses, including circle lenses, without a prescription. Any type of contact lens is a medical device that requires a prescription, proper fitting by an eye care professional and a commitment to proper care by the consumer.". (MEDLINEplus)
How Regulation Kills Medical Innovation Jul 16, 2010
The EPA's potentially catastrophic treatment of CO2 has been greeted by high-profile congressional and public resistance but under the radar another ubiquitous federal agency, the FDA, has been killing innovation, companies and jobs in sectors drugs, vaccines and medical devices that have been among America's most successful for decades ... The agency has increased the amounts of data that will need to be obtained and submitted to regulators for medical devices including pacemakers, artificial... (Investors Business Daily)
The Bitter Fruit of Obamacare Jul 16, 2010 Johnson & Johnson paying $480 million for Micrus Jul 14, 2010 SecureLogix wins voice security contract Jul 14, 2010 Covidien completes $2.6B ev3 purchase Jul 13, 2010 Sicel eyes $20M fundraiser Jul 13, 2010 New Way to Expand Donor Pool for Transplant Organs? Jul 13, 2010 Sparton to acquire some Delphi Med. assets Jul 13, 2010 medical device Jul 13, 2010 Impenetrable coating mimics leaf Jul 12, 2010 ObamaCare: Dream Turned Nightmare Jul 11, 2010 City goes high-tech with TGen partnership Jul 10, 2010 Johnson & Johnson Jul 10, 2010 Biotech research lifted by tax credit Jul 10, 2010 Miniature Energy Harvesting Technology Could Power Wireless Electronics Jul 10, 2010 Kauffman study: Only startups bring real job growth Jul 9, 2010 Florida's medical device makers score a break Jul 7, 2010 Simulation-Based Matchmaking for Shape Memory Alloys Jul 6, 2010 In India, for India: Medical device makers plug in Jul 5, 2010 Disservice to residents (1) Jul 5, 2010 Coming attractions in life sciences Jul 4, 2010 Micrus Endovascular Jul 3, 2010 Report: Sunshine returns to Fla. economy Jul 3, 2010 NYT: Factory jobs return, but skilled workers scarce Jul 2, 2010 House Democrats Push To End 'Pay For Delay' ...Medicare: New Program To Save Patients 32% On ... Jul 2, 2010 Tax breaks granted, but selectively Jul 1, 2010 SV Life Sciences closes new $523M fund Jul 1, 2010 1st 'Boettcher Investigators' named Jul 1, 2010 MELA Sciences Inc. Jul 1, 2010 SonoSite completes $68M VisualSonics buy Jul 1, 2010 State board withholds information on tax break votes Jun 30, 2010 Leading Rep. Gubernatorial Candidates Talk Jobs Jun 30, 2010 Aurora to open Grafton hospital Nov. 1 Jun 30, 2010 SRI, Stanford in medical device program Jun 30, 2010 Genome Sequencing for the Rest of Us Jun 29, 2010 The doctor will e you now Cardiologist Eric Topol sets aside his fresh garden salad and holds up an iPhone with a palpable sense of glee. Jun 28, 2010 Samsung, TSMC hit by ITC complaint Jun 25, 2010 Biotech employment in Florida up 18 percent, report says Jun 25, 2010 2010's Best Designed Products Jun 24, 2010 Patents seen as low priority for software firms Jun 24, 2010 School of Hock Jun 24, 2010 Nanodevices That Change Shape on Demand Jun 23, 2010 SonoSite signs distribution deal with UMI Jun 23, 2010 FDA to alter rules on devices Jun 23, 2010 Award-winning Erie plastics company eyes expansion Jun 19, 2010 Altek Launches "Leo", the World's Newest, Smartest, 14 Megapixel, 3.5G Professional Camera Phone at CommunicAsia2010 Jun 18, 2010 60 Severed Heads Found at Airport Jun 18, 2010 Genetic Testing Company's Mix Up Stirs Regulation ... Jun 18, 2010 Somanetics Corp. Jun 17, 2010 FCC, FDA take teamwork approach to telemedicine Jun 17, 2010 Event focuses on medical instrumentation Jun 16, 2010 Government to Allow Use of Drugs Approved Outside the Country, Sankei Says Jun 16, 2010 No place like home Jun 16, 2010 Synergetics Q3 profit soars Jun 15, 2010 FDA groups genetic tests with medical devices, requiring approval Jun 15, 2010 Marlborough biofuel start-up develops capital idea Jun 14, 2010 Economy thins ranks of real estate professionals Jun 14, 2010 FDA to review personal gene-testing kits Jun 13, 2010 FDA Takes Issue With Genetic Tests From 5 Firms Jun 13, 2010 ON THE WEB: Read the letters (Under News & Events heading) Jun 12, 2010 FDA says genetic tests must get approval Jun 12, 2010 Fund Managers Tracking Indexes Face Biggest Russell Rebalance Since 2007 Jun 12, 2010 DPM: M'sia's health performance can be benchmark for others Jun 12, 2010 FDA cracks down on genetic test makers Jun 12, 2010 SonoSite announces $50M stock repurchase Jun 12, 2010 Palestinian shot dead after hitting Israeli police Jun 12, 2010
Taxes on medical devices will also be going up to 2. 9 percent under ObamaCare. (Townhall.com)
UCSD's push to test therapies gets a lift Jul 15, 2010
The money will help address a basic problem in the development of drugs and medical devices. When scientists make new discoveries, the research can stall in the petri dish unless private investors step up to fund the costly process of testing the experimental treatment in humans. (San Diego Union-Tribune)
Johnson & Johnson makes a wide range of pharmaceuticals and medical devices ... The company's other units make consumer health care products, pharmaceuticals and medical devices. (KGW Northwest NewsChannel 8, OR -- Business)
Health First selected SecureLogix to better protect patient information by defending its data network, information systems and advanced medical devices from telephone-based attacks and unauthorized access over voice lines. These added security measures will keep Health First in maintaining compliance with medical privacy regulations as mandated by the Health Insurance Portability and Accountability Act or HIPAA.. (San Antonio Business Journal, TX)
said Monday that it completed its to buy , which makes medical devices to treat peripheral vascular and neurovascular diseases ... Covidien said it will report ev3, now an indirect, wholly-owned subsidiary, as part of Covidien s vascular products line in its medical devices business segment. (St. Louis Business Journal, MO)
Medical devices, with a quicker regulatory path, offer investors a quicker return on their investment. Sicel is further along than many early stage companies. (Raleigh Triangle Business Journal, NC)
This research has led to the development of new medical devices to allow the rapid cooling of the organs, which have been approved by the NHS and are now used in clinical practice ... Dr Noel Carter, senior pharmacy lecturer in the Faculty of Applied Sciences and is part of the research group, said: "The primary aim of our research is to expand the donor pool. If we can achieve this then the benefits will be incredible. "One of our PhD students Alex Navarro, who graduates next week, has based... (Science Daily)
Longmont-based Delphi Medical Systems makes therapeutic medical devices, including blood separation equipment, spinal surgery products and 3-D eye mapping devices. It is a unit of Troy, Mich. (Denver Business Journal, CO)
Two years after passing a law that required medical companies to disclose some of their gifts to doctors and banned others, there is a push in the Legislature to strike down the law. 6 billion acquisition of endovascular surgery device maker ev3 Inc.. (MSNBC -- Health)
The company, , will address a range of market applications, from self-cleaning surfaces for medical devices and protective coatings for electronics to corrosion resistance for boats and metal-based products, said CEO Lawrence Chavez. We ll sell very repellent coating materials to solve expensive problems, such as water damage, corrosion, fogging and ice buildup, Chavez said. (New Mexico Business Weekly, NM)
These include "the $60 billion tax on health plans, the $20 billion tax on medical devices and the $27 billion tax on prescription drugs." Makes you wonder which party is on the side of the little guy. One way premiums will increase is through Americans' making rational economic decisions when faced with higher health costs or the paying of a penalty something perhaps unjustly described as "gaming the system." ObamaCare, it turns out, is a system begging to be gamed. (Investors Business Daily)
Whyte reiterated that bioscience technology is a field that applies life processes to practical uses, from manufacturing medical devices, pharmaceutical drugs, pacemakers, and genetic engineering to gene therapy. As part of the EDIS to bring a bioscience presence to Peoria, two local partnerships were sought that have different approaches to attracting bioscience businesses. (Peoria Times, AZ)
Shares of some top medical devices companies were mixed at the close of trading ... Shares of some top medical devices companies are mixed at 10 a.m.. (MSNBC -- Business)
I think it s going to be something everyone s going to be looking at in biotech, life sciences and medical devices, he says. Everyone s taking a shot at it. (Buffalo Business First, NY)
"One of the major limitations of current active implantable biomedical devices is that they are battery powered. This means that they either have to be recharged or replaced periodically. Dr. Shi's group has demonstrated a technology that will allow implantable devices to recover some of the mechanical energy in flowing blood or peristaltic fluid movement in the GI tract to power smart implanable biomedical devices," says, Dr. Arthur Ritter, Director of Biomedical Engineering at Stevens ... 21,... (Science Daily)
Nine-month-old Novita, which makes medical devices, has brought in almost $1 million in investments. Aly Van Dyke writes for the Kansas City Business Journal, a sister paper. (St. Louis Business Journal, MO)
Based on its passage, the is developing plans to lure more companies that manufacture medical devices to the Tampa Bay area. The measure, signed by Gov. Charlie Crist on May 28, did away with a requirement that companies that make medical devices get permits from the and open their facilities for inspection by the state every two years. (Tampa Bay Business Journal, FL)
From the new material, the researchers expect a stable shape memory effect and improved lifetime, e.g. for applications in medical devices such as stents. See Also. (Science Daily)
The market for medical devices is worth up to $3 billion and growing at more than 10 percent a year, according to PriceWaterhouseCoopers (PWC), drawing foreign firms such as GE Healthcare, a venture with Wipro, Siemens and Philips, which are also pursuing a local-for-local strategy in India. "In theory, the opportunity is huge," says Sujay Shetty, leader of the pharma practice at PWC in India. (India Times)
Disservice to residents - Somerset - Daily American. I am writing in response to Wallace Miller's letter to this editor dated June 25. (Somerset Daily American, PA)
When I talk about the life sciences industry in our neighborhood, it includes everything from university research labs to major global drug companies like AG that develop new products here to makers of medical devices like to hospitals where new treatments are tested to hometown drug makers like , a publicly traded Cambridge company that makes injectable drugs used to treat conditions like alcoholism and schizophrenia. Supporting the formation of new life sciences start-ups are wealthy angel... (Boston Globe)
Micrus develops, manufactures, and markets implantable and disposable medical devices used to treat cerebral vascular diseases. Micrus will begin trading after the close of trading on Wednesday. (Boston Globe)
The best strategy for the state is to boost the presence of industries such as biotechnology, medical devices, aerospace, international trade and finance, simulation, alternative energy, and film, television and new media, the report said. Read the full report. (Tampa Bay Business Journal, FL)
Makers of innovative products like advanced medical devices and wind turbines are among those growing quickly and looking to hire, and they too need higher skills. Thats where youre seeing the pain point, said Baiju R. Shah, chief executive of BioEnterprise, a nonprofit group in Cleveland trying to turn the region into a center for medical innovation. (MSNBC -- Business)
Medicare: New Program To Save Patients 32% On Medical Devices - FOXBusiness ... Medicare: New Program To Save Patients 32% On Medical Devices ... Medicare beneficiaries are expected to save 32% on costs for medical devices in nine U.S. metropolitan areas in the first round of a new competitive bidding program, the government said Thursday. (Fox News)
5 million to expand a distribution center in Quincy on the grounds the Natick-based maker of medical devices failed to meet job goals for a previous expansion project the state subsidized. The board also turned down Allegrone Construction, a housing contractor that asked for $360,000 to expand its facilities in Lenox, determining it was primarily a local company that would have remained in Massachusetts. (Boston Globe)
SVLSF V will be focused on providing start-up, early stage and expansion capital to life sciences companies in the United States and Europe and will invest across a range of life sciences sectors, including biotechnology and pharmaceuticals, medical devices, health care services and health care information technology. The firm said it expects investment size to be between $5 million and $35 million. (San Jose Business Journal, CA)
Melissa Reynolds, assistant professor of chemistry at , studying nitric-oxide releasing materials for cardiovascular medical devices. Grants for their projects range from $200,000 to $300,000. (Denver Business Journal, CO)
The Irvington, N.Y., maker of medical devices will offer 2. 2 million shares to the public at $7. (Boston Globe)
Bothell-based SonoSite (NASDAQ: SONO), which makes ultrasound medical devices. SonoSite said the purchase of VisualSonics will expand its presence in the pre-clinical ultrasound market. (Puget Sound Business Journal, WA)
The Natick maker of medical devices promised to invest $55 million in its Quincy distribution center by 2013 and create five full-time jobs by 2018. Boston Scientific has previously drawn criticism for receiving millions of dollars in tax incentives to expand in Marlborough, and then cutting jobs. (Boston Globe)
In order to retain promising students, Deal says the state needs to promote its technical colleges and strong workforce to help appeal to growing industries, like medical devices and energy. Former Secretary of State Karen Handel says she also wants to boost private sector jobs, with a focus on small businesses and entrepreneurs. (13WMAZ.com, GA)
Toward the end of summer medical devices to support surgeries, diagnostics and rehabilitation will begin to arrive, said Len Wilk, president of. Equipment installation can take two to three months to complete. (Milwaukee Business Journal, WI)
and the said Tuesday they have established a program to accelerate the innovation of medical devices and bring them to market faster ... "The MISTRAL Collaborative, through the broad clinical, engineering, and commercialization resources of our member institutions, hopes to catalyze breakthrough device development by performing the initial R&D, partnering with industry, and identifying paths to market for badly-needed pediatric medical devices.". (San Jose Business Journal, CA)
"From that perspective, they do need to be regulated as medical devices.". The FDA, which had provided relatively loose rules for consumer genetic testing, is now revaluating the industry's methods and will begin asking companies to provide data about how they interpret the scans for customers. (Scientific American)
He believes that the wireless medical devices that are now coming to market cannot only save lives, but spot problems as soon as they begin to appear ... Will these emerging wireless medical devices produce more information than a physician can absorb and use ... What wireless medical devices will we have in just a few years that will seem, well, magical. (San Diego Union-Tribune)
STC licenses technology developed at UNM, including optics, microfluidics, and high performance materials as well as therapeutics, diagnostics, medical devices, and drug discovery tools. Free Subscription to EE Times. (EETimes)
Battelle counted positions in agriculture, pharmaceuticals, medical devices and research ... for example, has built a biotech industry by focusing on medical devices and the shipping and distribution of drugs and devices. (The Palm Beach Post)
Choosing the medalists in some of the 18 categories -- everything from medical devices to home decor -- was easy. And seeing the reach of modern design has been exhilarating. (FastCompany)
Among biotech, medical devices and hardware startups, patents were the second most favored means of preserving a competitive edge. While software companies also sought to be first movers, their second-favorite business-building strategy was the use of complementary assets - for instance, giving away a free version of a tool to sell premium upgrades or services. (San Francisco Chronicle -- Technology)
On June 11, the to consumer genomics companies (and one to DNA technology firm Illumina), informing them that their services were to be treated like medical devices and regulated as such. That means that the tests will be held to the same standards as other medical tests: They must measure what the companies say they measure, consistently and accurately. (Slate)
"This new self-assembly based nanofabrication technology could lead to nanoscale medical devices and drug delivery systems, such as virus mimics that introduce drugs directly into diseased cells," said co-investigator and Wyss Institute director Don Ingber. A nanodevice that can spring open in response to a chemical or mechanical signal could ensure that drugs not only arrive at the intended target but are also released when and where desired. (Science Daily)
said it s signed a deal to distribute its ultrasound medical devices with United Medical Systems (UMI) of San Jose, Calif. The Seattle company (NASDAQ: SONO) said UMI will distribute its products into certain small office markets. (Puget Sound Business Journal, WA)
An initial report on revamping the FDA s approval process for medical devices, including changes in the development of clinical trials, is expected to be released for public comment in the coming weeks. New procedures could take effect later this year in what is known in the industry as the 510(k) medical device approval process. (Boston Globe)
The manufacturer of plastic electrical connectors, medical devices and telecommunications products was recently honored as one of the nation's top companies by Plastics News magazine. CHRISTOPHER MILLETTE/ ERIE TIMES-NEWS. (Erie Times-News, PA)
Altek is also advancing into other areas of business, including automotive image processing applications, high-resolution camera modules, and optical medical devices. Altek looks to utilize its core expertise in digital imaging to provide advanced, practical solutions to a wide spectrum of users. (JCN Network, Japan)
to Medtronic, a company that produces medical devices like defibrillators, based in Fort Worth, Texas. Camper said the heads had been improperly labeled and the documents connected to the opaque plastic containers did not indicate what was inside. (ABC News)
Alberto Gutierrez, who leads diagnostic test regulation at the FDA, issued five DTC genetic testing companies letters on June 11 notifying them that their tests are considered medical devices and will require regulatory approval in order to be sold ... In the FDA s letter to 23andMe, Gutierrez wrote: This premarket review of medical devices enables the FDA to protect the public from medical products that may pose an unreasonable risk of harm. (Fox News)
which makes medical devices, is buying its distribution partner , of Michigan, for almost $300 million. Covidien distributes Somanetics diagnostic equipment, called the INVOS Cerebral/Somatic Oximeter, overseas. (Boston Globe)
Goal is to 'streamline review' of wireless broadband medical devices ... The FCC, which oversees communications, and the FDA, which oversees medical devices, separately have dealt with regulation for wireless telemedicine and telehealth applications used in remote locations to deliver health information or care ... In the FCCs National Broadband Plan, the commission said its work to advance broadband communications will help foster the use of remote medical devices to reduce costs and improve... (FCW.com)
AAMI s roughly 6,000 members include physicians, nurses, hospital administrators, manufacturers, distributors, clinical and biomedical engineers and technicians, and other professionals with an interest in medical devices. Most Read Stories. (Tampa Bay Business Journal, FL)
June 16 (Bloomberg) -- Japan plans to allow the use of drugs and medical devices that have been approved for use outside the country to expand treatment options, the Sankei newspaper reported, without saying where it got the information ... Some drugs and medical devices used overseas take a long time to get approved by regulators in Japan, creating delays to provide the global standard of treatment to patients, according to the report. (Bloomberg -- Japan)
He also likes blood-products maker CSL, medical devices company ResMed and the property trust Westfield. A private client adviser with Baillieu Polkinghorne, Colin Cruickshank, also likes Westfield, which he regards as the leading property trust. (Sydney Morning Herald -- Business)
-based Synergetics USA Inc. (Nasdaq: SURG) manufactures and designs medical devices for use in ophthalmic surgery and neurosurgery. Most Read Stories. (St. Louis Business Journal, MO)
The FDA wrote last week to the following companies, informing them their products are unapproved medical devices ... In letters sent last week, the FDA told five companies it considers their tests unapproved medical devices ... In his letters, Gutierrez said the tests constitute medical devices because they are "intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease" or are "intended to affect the structure or function of... (USA Today -- News)
Exogenesis, founded in 2005, develops what it calls gas cluster ion beam technology for improving the surfaces of implantable medical devices. . (Boston Globe)
He works as a commissioned sales representative for in Sacramento, which distributes medical devices used in joint replacement and other surgery. He wants to keep his thumb in commercial real estate, and plans to keep his license current, but isn t committed to more than that. (Sacramento Business Journal, CA)
Consumers may make decisions based on the outcome of these tests, which should be reviewed under the same process used for medical devices, the Food and Drug Administration said in letters released Friday to 23andMe of Mountain View, Navigenics of Foster City, deCODE Genetics, Illumina Inc. and Knome Inc. The agency will decide whether the products can remain on the market after hearing what claims the companies want to make about their benefits ... Under FDA regulations, those technologies must... (San Francisco Chronicle)
The FDA letters notify each company that their tests are considered medical devices and therefore must be federally approved as safe and effective. None of the companies has submitted their products for approval, according to the FDA.. (KWTX.com, TX)
In Vitro Diagnostics. Section Contents Menu. (USA Today -- Money)
The FDA sent letters this week to five companies, saying their tests are medical devices that must receive regulatory approval before they can be marketed. Premarket review allows for an independent and unbiased assessment of a diagnostic test s ability to generate test results that can reliably be used to support good health care decisions, Alberto Gutierrez, who is in charge of diagnostic test regulation at the FDA, wrote in the letters. (Boston Globe)
Companies such as Covidien Plc, a maker of medical devices, and Tyco International Ltd., the worlds largest maker of security systems, were from the Russell 1000 after moving their incorporation from the U.S.. After a similar rule change by S&P, Russell decided to take into account the location of a companys assets and the primary listing place for its shares, making it possible those companies, as well as Thomson Reuters Corp., Ace Ltd. and Ingersoll-Rand Plc, will be reinstated,... (Bloomberg -- US)
"In the health sector, we expect greater revenue to be generated by more aggressive participation in the healthcare travel industry, manufacturing of medical devices and pharmaceuticals," he said. - Bernama. (The Star Online, Malaysia -- News)
The FDA said the companies' products are considered medical devices and so must be deemed safe and effective by the federal agency. None of the companies have received that approval thus far, the FDA said. (San Jose Business Journal, CA)
SonoSite Inc., a maker of ultrasound medical devices, said it may repurchase an additional $50 million of its common stock over the next 12 months. Since February, the Bothell, Wash. (Puget Sound Business Journal, WA)
Fattouh said Israeli officials rebuffed Palestinian requests for construction goods, raw materials for factories to operate and medical devices. "I think Israel wants to diffuse international pressure," said Fattouh. (Salon)
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