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Medtronic Revenue Gets Burned By Hurricane And Fire

Medtronic Revenue Gets Burned By Hurricane And Fire

Editor's note: This story has been updated to include a statement from Medtronic. Medtronic said late last week that Hurricane Maria may have damaged its fiscal 2018 second-quarter revenue and non-GAAP net earnings by up to $250 million. As if that weren’t bad enough, the company now faces potential impact from the deadly wildfires tearing through Northern California. According to a Star Tribune report, Medtronic evacuated buildings in Santa Rosa, CA on Monday in response to the fires that have ravaged through the area. The company has four facilities in the Santa Rosa and the Sonoma County region that could be affected by the fires, according to the report. In an email to MDDI Qmed on Wednesday, Medtronic spokesperson Wendy Dougherty said the company's priority right now is the safety of Medtronic employees and their families who live in the area, many of whom are being evacuated. "On an ongoing basis, we are accounting for and keeping in contact with employees in the area. All facilities in the area are closed until further notice. Our thoughts are with our employees, their families, and the entire Sonoma and Napa communities impacted by the wildfires," Dougherty said. Monday's evacuation came just three days after Medtronic provided an update on the estimated financial impact from Hurricane Maria in the second quarter. While the company expects some non-recurring expenses directly related to the recovery efforts in Puerto Rico to be excluded from its non-GAAP earnings, expenses related to the impact outside of Puerto Rico will be considered operating expenses. It's too early to determine the ongoing impact, if any, from Hurricane Maria beyond the second quarter, Medtronic said. Each of Medtronic's four business groups has some level of manufacturing across four maj Continue reading >>

Medtronic Mpi Northern California Chapter

Medtronic Mpi Northern California Chapter

The move toward value-based healthcare is gradually restructuring healthcare to better reward providers and healthcare delivery systems that can provide care in ways that improve clinical outcomes while lowering overall costs. As an acknowledgement of this shift in healthcare, Medtronic is sponsoring the online Insight Center hosted by New England Journal of Medicine and Harvard Business Review. This years Insight Center is Measuring Costs and Outcomes in Healthcare. Medtronic is proud to be participating as both a sponsor and as a keen stakeholder in this discussion. At Medtronic, we define value-based healthcare as an effort to develop and deploy products, services and integrated solutions that improve patient outcomes per dollar spent in the healthcare system by improving the quality of care and/or reducing the associated expense. Most importantly, the value derived from the quality of care isnt determined at a specific point in time that focuses on transactional value. Instead, value is measured holistically over a longer time horizon and in ways that are meaningful to the patient. Continue reading >>

Surgical Device Maker Misled Fda, Whistleblower Contends

Surgical Device Maker Misled Fda, Whistleblower Contends

erome Lew is a Hollywood screenwriter, and what happened to him could have come straight out of a horror film. In 2009, Lew went to UCLA Medical Center for surgery to relieve numbness and pain in his hands. The operation appeared to be a success. But he later began having trouble speaking. His left eye drooped. He developed severe nerve pain and weakness in his neck, arms, and hands. Lew concluded that the problem had been caused by an implant fused into his neck. It had never been approved to replace a bone in the neck. Jeremys injuries from this surgery have been devastating, said his attorney, Robert Vaage. His life was ripped away by one surgery and the devices that were used. In July, Lew, 52, settled with the University of California for $4.2 million; the manufacturer of the device, Medtronic, also settled for a confidential amount. Both parties denied any wrongdoing. Yet the legal challenge is not over for Medtronic . The company, one of the worlds largest medical device manufacturers, now faces a whistleblower lawsuit that claims it sought Food and Drug Administration approval for its devices under false pretenses and that the devices have been regularly used for a purpose that was never intended by regulators. Medical devices get to market faster in Europe but are tied to more safety issues They were labeled, not for cervical spine use, and yet in everything about them, including emails from their marketing folks, it makes clear that they were meant to be and were used in the cervical spine, said Dr. Vikas Saini, president of the Lown Institute , a Boston health care think tank, who has followed the case. Medical devices are lightly regulated by the FDA, and once they have been cleared by the agency, physicians may use them however they see fit. But patient ad Continue reading >>

Contact Us | Medtronic

Contact Us | Medtronic

If you have a security-related issue or concern, please do not fill out the online form below. Instead, call us directly at (800) 328-2518 and indicate the nature of your concern. Based on the urgency of the issue, a member of our security team will follow up in a timely manner. Medtronic is committed to providing quality customer service. However, due to the number of online inquiries we receive, we may not be able to respond within the same business day. If you need a response during the same business day, call Medtronic at (800) 633-8766 (toll-free within the United States) or (763) 514-4000 (worldwide). Do you have a security-related issue or concern? Are you a security researcher and want to report a possible medical device or product security vulnerability? Learn what to do . Contact Medtronic Outside the United States Please follow the link below to send a message directly to the Medtronic office in your country or region. I am a physician or healthcare professional Do you have a Medtronic device or therapy? * To share an idea for a possible new product or therapy, please visit Innovate with Medtronic . We ask for full contact information only to consult your Medtronic records when replying to your question. We never share your contact information. Please note: We will respond to your comments or inquiry via email or telephone. Our email response will include your first and last names and will repeat your message to us, which could include personal information about your health. If this is a cause for concern, please call Medtronic Patient Services instead of submitting this form. For more information on how we safeguard your data, please review our privacy policy . Please note: We will respond to your comments or inquiry via email or telephone. Our email respon Continue reading >>

Medtronic's Santa Rosa Facilities Survive California Wildfires - Massdevice

Medtronic's Santa Rosa Facilities Survive California Wildfires - Massdevice

Home Medtronics Santa Rosa facilities survive California wildfires Medtronics Santa Rosa facilities survive California wildfires While much of Santa Rosa, Calif. has been ravaged by wildfires sweeping across the region, Medtronic s (NYSE: MDT ) 2 facilities in the area are still standing, but inaccessible, according to a StarTribune report. While the facilities remain, the Fridley, Minn.-based company is still trying to reach out to employees in the area and assess the impact it has on them, as well. We have some initial, positive observations of our Fountaingrove and Coffey Lane facilities, which were at most risk of being impacted by the fires. We are working to gain additional information regarding the specific impacts and damages sustained. We will have additional information on site impacts once we can gain access to facilities, Medtronic spokesperson Fernando Vivanco told the StarTribune. The companys Fountaingrove and Coffey Lane facilities in Santa Rosa are primarily administrative offices, according to the report, but also include research & development operations for vascular and heart devices. Other facilities in the area are used for warehousing materials and products. These facilities have already given these house designs for the home builder so that they can move out of the way. The affected Fountaingrove and Coffey Lane buildings appeared to be within the mandatory evacuation zone in Santa Rosa, according to the StarTribune. The companys nearby Brickway and Skylane facilities, while not affected, were also difficult to access due to the fires. The wildfires and recent hurricanes hitting Texas, Florida and Puerto Rico have had a significant impact on Medtronic, with the company estimating $250 million in damages from the natural dis Continue reading >>

Medtronic Headquarters Information

Medtronic Headquarters Information

Medtronic is a medical company founded in 1949. The company specializes in innovation medical solutions for pain, neurological conditions, heart conditions and diabetes care. The aim of the company is to help patients live a better, longer life. Though the company headquarters is located in the United States offices are located throughout the world. Many of the Medtronic offices are located in countries with Universal Health Care giving Medtronic headquarters a breadth of knowledge far exceeding some other medical companies. You can find the Medtronic headquarters in Minneapolis, Minnesota. There is a contact phone number and mailing address on the official website. We also found a list of executives and the names of the people on the board of directors. There is no official contact form for Medtronic headquarters, but there is a general information contact form. Address: You can address your letter to Medtronic headquarters in Minneapolis, Minnesota. An attention line with the name of the person or the department you are trying to reach could speed up return communication. Medtronic Headquarters 710 Medtronic Pkwy Mail Stop: L100 Minneapolis, MN 55432 Phone Number: To reach Medtronic headquarters, call 1-763-514-4000. You can also choose to contact the company using the toll-free number at 1-800-633-8766. Email: When you want to reach Medtronic headquarters by email you must use the general information contact form [+] located on the official website. You must choose your country and describe, in detail, why you are contacting the company. There is also a place to include your contact information. Double check this information to ensure you receive a response from Medtronic headquarters. Website: You can find information on the Medtronic headquarters and the company h Continue reading >>

Medtronic Evacuates California Facilities Because Of Wildfires

Medtronic Evacuates California Facilities Because Of Wildfires

Deadly wildfires in Northern California on Monday forced the evacuation of Medtronic buildings in Santa Rosa that are involved with engineering medical devices to treat diseased hearts and arteries. Medtronic spokesman Fernando Vivanco confirmed late Monday that Medtronic has four facilities in the Santa Rosa and the Sonoma County region that could be affected by the fires, which have claimed at least 10 lives and destroyed thousands of structures in a wide area north of California's Bay Area. Medtronic's Fountaingrove and Coffey Lane facilities in the northern section of Santa Rosa were the most at risk of being affected by the fires, Vivanco said. Although the facilities were evacuated per an order from local fire authorities, as of 5 p.m. Monday, it wasn't clear whether the buildings or employees had been directly harmed. "We are closely monitoring the wildfires in Santa Rosa and Sonoma County, and our first priority is the safety of our employees, many of whom are being evacuated," Vivanco said via e-mail. "We have initiated our business continuity plans and are accounting for and keeping in contact with employees in the area." Buildings in the region house administrative offices and research-and-development facilities for Medtronic's coronary devices division, which include minimally invasive replacement heart valves and coronary stents, according to securities filings. It's the second time in less than a month that Medtronic had to activate emergency preparedness plans in response to a natural disaster. Last month Medtronic's manufacturing operations in Puerto Rico were temporarily closed as a precaution ahead of Hurricane Maria, which made a direct hit on the island Sept. 20. The storm caused dozens of fatalities around the island and knocked out power for resid Continue reading >>

Medtronic Vascular, Inc. Key Developments

Medtronic Vascular, Inc. Key Developments

Medtronic Vascular, Inc. designs and manufactures technologies for coronary, peripheral, and neurovascular indications. The companys products include S7 Zipper MX Coronary Stent System, Clo-Sur PAD nonwoven Hydrophilic wound dressing, Launcher Coronary Guide Catheter, and Stormer Over-the-Wire Balloon Dilatation Catheter. The company also offers Bridge Assurant balloon-expandable stent delivery system, GuardWire Plus Temporary Occlusion and Aspiration System, and S660 Coronary Stent. The company was formerly known as Medtronic AVE, Inc. and changed its name to Medtronic Vascular, Inc. in October 2003. The company was incorporated in 1991 and is based in Santa Rosa, California. As of January... Medtronic Vascular, Inc. designs and manufactures technologies for coronary, peripheral, and neurovascular indications. The companys products include S7 Zipper MX Coronary Stent System, Clo-Sur PAD nonwoven Hydrophilic wound dressing, Launcher Coronary Guide Catheter, and Stormer Over-the-Wire Balloon Dilatation Catheter. The company also offers Bridge Assurant balloon-expandable stent delivery system, GuardWire Plus Temporary Occlusion and Aspiration System, and S660 Coronary Stent. The company was formerly known as Medtronic AVE, Inc. and changed its name to Medtronic Vascular, Inc. in October 2003. The company was incorporated in 1991 and is based in Santa Rosa, California. As of January 29, 1999, Medtronic Vascular, Inc. operates as a subsidiary of Medtronic plc. Continue reading >>

Medtronic Cardiovascular (santa Rosa)

Medtronic Cardiovascular (santa Rosa)

At Medtronic, our approach to corporate citizenship begins with our Mission, written 50 years ago by our founder Earl Bakken. In it he articulates the company's call to "alleviate pain, restore health and extend life" and "to maintain good citizenship as a company."Our corporate citizenship vision is two-fold: to operate responsibly in all facets where our business intersects with society, and to leverage our resources, assets, and expertise to catalyze dramatic improvement in the lives of those affected by chronic disease. To demonstrate our vision, we align our citizenship initiatives with five pillars that define our unique focus: Global Leadership in Addressing Chronic Disease, Collaborative Culture of Innovation, Responsibility in the Marketplace, Total Employee Engagement and Progressive Environmental Stewardship. 2018 California Life Sciences Association. All rights reserved | Website Terms and Conditions | Custom Design & Development by AldenMC CLSA Bay Area: 701 Gateway Boulevard, Suite 440, South San Francisco, CA 94080 | CLSA Los Angeles: 605 East Huntington Drive, Suite 103, Monrovia, CA 91016 | CLSA Sacramento: 1201 K St. Suite 1840, Sacramento, CA 95814 | CLSA San Diego: 9191 Towne Centre Drive, Suite 450, San Diego, CA 92122 | CLSA Washington D.C: 1350 I Street, NW, Suite 830, Washington, DC 20005 Continue reading >>

Medtronic Orders Employees To Evacuate California Facilities

Medtronic Orders Employees To Evacuate California Facilities

Medtronic Orders Employees to Evacuate California Facilities By Alex Keown , BioSpace.com Breaking News Staff MINNEAPOLIS Days after Medtronic resumed some manufacturing in its Puerto Rico facilities following the devastation from Hurricane Maria, the company has been forced to suspend operations at four Northern California facilities and evacuate employees due to the threat of wildfires. Deadly fires are burning a swath across much of the region, consuming woodland areas, as well as residential and business districts. More than 1,500 buildings , home and businesses, have been destroyed by the fires, according to NBC. This morning the Minneapolis Star-Tribune reported that Medtronic evacuated four facilities in Sonoma County and Santa Rosa, Calif. The evacuation was ordered by fire officials, the Star-Tribune said, citing Medtronic spokesman Fernando Vivanco. "We are closely monitoring the wildfires in Santa Rosa and Sonoma County, and our first priority is the safety of our employees, many of whom are being evacuated," Vivanco said in an email to the publication. "We have initiated our business continuity plans and are accounting for and keeping in contact with employees in the area." It was unclear how many Medtronic employees typically work at those facilities. The Star-Tribune said the Medtronic facilities in the area include the administrative offices and research-and-development facilities for Medtronic's coronary devices division. It is not yet known when the area will be deemed safe for Medtronic to resume operations. More than 20,000 people have been evacuated from the area, NBC said. The wildfires stretch across eight California counties, an area of about 114 square miles, according to reports. In late September, Medtronic saw its Puerto Rico facilities tempo Continue reading >>

Medtronic And Irvine Heart Valve Maker Settle Patent Dispute

Medtronic And Irvine Heart Valve Maker Settle Patent Dispute

Medtronic and Irvine heart valve maker settle patent dispute Medtronic and Edwards Lifesciences Corp. announced a settlement Tuesday to end a patent dispute over a heart valve that can be implanted with a minimally invasive procedure rather than open-heart surgery. (Jacquelyn Martin / Associated Press) , an Irvine heart valve maker, on Tuesday announced a settlement to end a long-running patent dispute that includes a one-time payment by Medtronic of $750 million and annual royalties of between $40 million and $60 million to Edwards through 2022, the companies said. The agreement ends a dispute that began in 2008 when Edwards Lifesciences accused Minneapolis-based Medtronic of infringing on its patent for a heart valve that can be implanted in a minimally invasive procedure, inserted through an artery rather than requiring open-heart surgery. Under the terms of the agreement, the two companies also agreed to avoid litigation over the heart valves for the next eight years. They also will dismiss any currently pending litigation, the companies said. "We are pleased to reach an agreement that preserves physician choice while also recognizing Edwards' leadership in pioneering the transcatheter heart valves that are chosen most often by physicians worldwide," said Edwards Chief Executive Michael A. Mussallem in a statement. "This agreement allows us to move forward, fully dedicating our time and resources to helping patients." As part of the agreement, Medtronic and Edwards do not admit their products infringe on any patents or that any are invalid. The one-time $750-million payment by Medtronic reduced the company's fiscal fourth-quarter earnings by 54%, Medtronic said Tuesday. Net profit was $448 million, or 44 cents a diluted share, compared with the same period a year e Continue reading >>

Minnesota-based Medtronic Inc. Pays Us $23.5 Million To Settle Claims That Company Paid Kickbacks To Physicians

Minnesota-based Medtronic Inc. Pays Us $23.5 Million To Settle Claims That Company Paid Kickbacks To Physicians

Minnesota-Based Medtronic Inc. Pays US $23.5 Million to Settle Claims That Company Paid Kickbacks to Physicians WASHINGTON Medtronic Inc. of Fridley, Minn., has agreed to pay the United States $23.5 million to resolve allegations that it violated the False Claim Act by using physician payments related to post-market studies and device registries as kickbacks to induce doctors to implant the companys pacemakers and defibrillators, the Justice Department announced today. Post-market studies are intended to assess the clinical performance of a medical device or drug after that device or drug has been approved by the Food and Drug Administration. Registries are collections of data maintained by a device manufacturer concerning its products that have been sold and implanted in patients. The United States contends that Medtronic caused false claims to be submitted to Medicare and Medicaid by using two post-market studies and two device registries as vehicles to pay participating physicians illegal kickbacks to induce them to implant Medtronic pacemakers and defibrillators. Although Medtronic collected data and information from participating physicians, each of the studies and registries required a new or previous implant of a Medtronic device in each patient, and in each case Medtronic paid participating physicians a fee ranging from approximately $1,000 to $2,000 per patient. The United States contends that Medtronic solicited physicians for the studies and registries in order to convert their business from a competitors product and/or persuade the physicians to continue using Medtronic products. Patients who rely on their healthcare providers to implant vital medical devices expect that those decisions will be made with the patients best interests in mind, said Tony West, Continue reading >>

California Court Allows State Law Claims Against Medtronic To Proceed; Rejects Preemption Argument

California Court Allows State Law Claims Against Medtronic To Proceed; Rejects Preemption Argument

Home > FDA > California Court Allows State Law Claims Against Medtronic to Proceed; Rejects Preemption Argument California Court Allows State Law Claims Against Medtronic to Proceed; Rejects Preemption Argument Posted in FDA, Litigation, Medical Devices, Product Safety The Superior Court for the County of Los Angeles ruled earlier this week in Cabana v. Stryker Biotech, LLC that a products liability action arising out of the off-label use of Medtronics INFUSE Bone Graft medical device could proceed by rejecting Medtronics summary judgment motion. Medtronic had argued that plaintiffs claims were both expressly and impliedly preempted by the Medical Device Amendments to the Federal Food, Drug & Cosmetic Act (FDCA). In the complaint, plaintiff alleged that she suffered severe pain after her doctor performed a surgical procedure using the Medtronic medical device, despite the fact that the device had not been approved by FDA for such use. Plaintiff also alleged that Medtronic had both directly and indirectly promoted the medical device for this off-label use. Medtronic countered that it manufactured, designed and labeled the device in accordance with the FDCA and FDA implementing regulations. Section 521 of the FDA prohibits the imposition of any requirement which is different from, or in addition to, any requirement imposed by federal law. 21 U.S.C. 360(k)(a)(1). Relying on that provision, and the Supreme Courts interpretation of it in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), Medtronic argued that plaintiff attempted to impose requirements both different from and in addition to requirements imposed by federal law because the device had already been approved by FDA. The court rejected the express preemption argument on the grounds that plaintiff here is alleging tha Continue reading >>

Medtronic Dodges Spine Device Fca Suit, For Now

Medtronic Dodges Spine Device Fca Suit, For Now

Medtronic Dodges Spine Device FCA Suit, For Now Law360, Los Angeles (February 13, 2017, 9:57 PM EST) -- A California federal judge on Monday tossed a False Claims Act suit alleging Medtronic was responsible for ineligible claims submitted to Medicare and Medicaid by marketing a back surgery device for use in a patients neck, but suggested the complaint could be amended to better explain how the device isnt safe, appropriate and medically necessary. The qui tam suit was filed by Bryan Shapiro, a former Medtronic Inc. sales representative and the sole member of the relator company, The Dan Abrams Company LLC. The operative complaint asserts 37 causes of action under federal and state False Claims Acts and is brought on behalf of the United States and 32 states. The relator plaintiff alleges Medtronic is responsible for claims submitted to federal health care programs for its Verte-Stack device which replaces the space left when a vertebra and adjacent disc are removed and offered kickbacks to encourage health care providers use of the product. Medtronic asked the court to dismiss the whistleblower suit, maintaining, among other arguments, that off-label use of an FDA -approved product thats approved by a doctor is lawful and that the U.S. Federal Food, Drug and Cosmetic Act cant be privately enforced. During Mondays proceedings, U.S. District Court Judge John A. Kronstadt agreed. "The allegation is the defendant's products were used for neck surgeries and were not approved specifically, Judge Kronstadt said. I think there's substantial authority that you cannot litigate in this action whether the FDA was misled or whether the FDA would have provided clearance had it known more about the defendant's products because that in effect creates a private right of action under t Continue reading >>

Keysight, Medtronic Campuses In Santa Rosa Spared Major Damage

Keysight, Medtronic Campuses In Santa Rosa Spared Major Damage

Should workers have the right to ignore after-hours emails? (1 of ) Charred cars in the parking lot at Keysight Technologies in the Fountaingrove neighborhood of Santa Rosa, California Monday. October 9, 2017.(Photo: Erik Castro/for The Press Democrat) (2 of ) Charred and melted cars in the parking lot at Keysight Technologies in the Fountaingrove neighborhood of Santa Rosa, California Monday. October 9, 2017.(Photo: Erik Castro/for The Press Democrat) Keysight, Medtronic campuses in Santa Rosa spared major damage Contrary to a Bay Area television news report, the Santa Rosa campus of Keysight Technologies wasnt destroyed Monday by the fire that ripped through Sonoma County, the companys chief executive said Tuesday. The fire did burn two modular buildings closest to Fountain Grove Parkway, CEO Ron Nersesian said. But the heart of the campus, four massive permanent buildings, appear to have suffered only minimal damage. Those four buildings and a recycling storage facility constitute nearly a million square feet of office and production space that Keysight plans to reopen, though not before next Monday. Nersesian, who flew back Monday from Germany, said a Keysight crisis response team visited the campus Tuesday and reported their initial findings to him. While the team will conduct further examinations, he said, we just thank God that those (permanent) buildings sustained minor damage from what we can see at this point. Keysight, a global electronics measurement company and the largest business headquartered in Sonoma County, has told its 1,100 workers they will receive the week off with full pay, Nersesian said. The company will update employees on a reopening date once more information is known. Keysight also will provide $10,000 to employees whove lost homes, he sai Continue reading >>

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