magnifying glass

Market Research Helps Device Companies Do the Homework

By Maria Fontanazza

…market research strategy? Robert Kaminsky: They of course vary from company to company, but for many medical device companies, cultural resistance is one of the hurdles. Many of the companies…

…market research strategy? Robert Kaminsky: They of course vary from company to company, but for many medical device companies, cultural resistance is one of the hurdles. Many of the companies…

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Cybersecurity

Side Effects: Cybersecurity and Medical Device Recalls

By Chris Harvey

…shouldn’t necessarily sideline product development, but companies should always incorporate recall planning and preparation into their innovation. That includes not only creating a written plan, but also testing that plan…

…shouldn’t necessarily sideline product development, but companies should always incorporate recall planning and preparation into their innovation. That includes not only creating a written plan, but also testing that plan…

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Theranos

Report: Theranos to Settle $140 Million Lawsuit with Walgreens

By MedTech Intelligence Staff

…is focusing efforts on its automated miniaturized testing platforms. In April Theranos also stated that it will reimburse Arizona residents for any amounts paid for the company’s blood testing services…

…is focusing efforts on its automated miniaturized testing platforms. In April Theranos also stated that it will reimburse Arizona residents for any amounts paid for the company’s blood testing services…

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Knee implant

Lifestyle and Aging Population Continue to Drive Asian Orthopedic Device Market

By Ames Gross

…medical device companies focus on producing medical equipment and home healthcare products, leaving the orthopedic market competitive for foreign companies. Taiwan is a regional leader in joint replacement procedures. More…

…medical device companies focus on producing medical equipment and home healthcare products, leaving the orthopedic market competitive for foreign companies. Taiwan is a regional leader in joint replacement procedures. More…

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Maquet Getinge, Datascope

Following Patient Death, Datascope Performs Field Correction of Intra-Aortic Balloon Pumps

By MedTech Intelligence Staff

Datascope Corp. is performing a voluntary global field correction of certain intra-aortic balloon pumps (IABP). The company received a complaint that an electrical test failure code #58 cause a device…

Datascope Corp. is performing a voluntary global field correction of certain intra-aortic balloon pumps (IABP). The company received a complaint that an electrical test failure code #58 cause a device…

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Stryker, Novadaq

Stryker Improves Surgical Imaging with Novadaq Acquisition

By MedTech Intelligence Staff

On Monday Stryker Corp. announced its intent to acquire Canada-based Novadaq Technologies, Inc. for $701 million. The definitive agreement beefs up Stryker’s product portfolio in open and plastic reconstructive surgery,…

On Monday Stryker Corp. announced its intent to acquire Canada-based Novadaq Technologies, Inc. for $701 million. The definitive agreement beefs up Stryker’s product portfolio in open and plastic reconstructive surgery,…

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Wearable Cloud, Medical Device Connectivity

FDA Sets Forth Digital Health Innovation Plan

By MedTech Intelligence Staff

…tools.” – FDA The agency is hosting a webinar on August 1to further explain the Innovation Action Plan and the Software Pilot Program. –END UPDATE– FDA has announced its commitment…

…tools.” – FDA The agency is hosting a webinar on August 1to further explain the Innovation Action Plan and the Software Pilot Program. –END UPDATE– FDA has announced its commitment…

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Medtech, innovation

Microfluidics Brings the Modern Lab to Point of Care

By Klaus Jopp

…said Henne van Heeren of EnablingMNT (Dordrecht, Netherlands), a company that provides marketing and strategic support for the micro and nanotechnology industries. Prime locations for the commercialization of microfluidics include…

…said Henne van Heeren of EnablingMNT (Dordrecht, Netherlands), a company that provides marketing and strategic support for the micro and nanotechnology industries. Prime locations for the commercialization of microfluidics include…

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Duodenoscope, ECRI

510(k)s for Reusable Devices Must Include Validated Data for Cleaning in IFUs

By MedTech Intelligence Staff

…that have been validated, along with validation data related to cleaning, disinfection and sterilization in their 510(k)s. Recently published on the Federal Register, the document, “Validated Instructions for Use and…

…that have been validated, along with validation data related to cleaning, disinfection and sterilization in their 510(k)s. Recently published on the Federal Register, the document, “Validated Instructions for Use and…

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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Recall, That Nasty 6-Letter Word!

By Dr. Christopher Joseph Devine

obtained by visiting the FDA’s website. Compliance for Dummies As the doctor previously mentioned, when in doubt, it is an acceptable practice to contact FDA and obtain their concurrence when…

obtained by visiting the FDA’s website. Compliance for Dummies As the doctor previously mentioned, when in doubt, it is an acceptable practice to contact FDA and obtain their concurrence when…

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