Cybersecurity

Side Effects: Cybersecurity and Medical Device Recalls

By Chris Harvey

…accuracy and consistency than ever before. But for all their benefits, they come with serious risks, especially when it comes to security. Potential hackers could gain access to highly sensitive…

…accuracy and consistency than ever before. But for all their benefits, they come with serious risks, especially when it comes to security. Potential hackers could gain access to highly sensitive…

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Theranos

Report: Theranos to Settle $140 Million Lawsuit with Walgreens

By MedTech Intelligence Staff

…Wall Street Journal. Neither Walgreens nor Theranos have publicly commented on the lawsuit. Nearly a year ago, CMS slapped Theranos with several sanctions, including revoking the company’s Newark, California lab’s…

…Wall Street Journal. Neither Walgreens nor Theranos have publicly commented on the lawsuit. Nearly a year ago, CMS slapped Theranos with several sanctions, including revoking the company’s Newark, California lab’s…

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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

…make it more difficult to reprocess instruments and accessories, such as lumens, hinges, shafts with lumens, crevices, ridges or grooves, porous materials, internal movable device components and features that may…

…make it more difficult to reprocess instruments and accessories, such as lumens, hinges, shafts with lumens, crevices, ridges or grooves, porous materials, internal movable device components and features that may…

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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

…C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (May 2017). Inspections, Compliance, Enforcement, and…

…C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (May 2017). Inspections, Compliance, Enforcement, and…

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