ZimmerBiomet

Zimmer Biomet Boosts Musculoskeletal Diagnostics with CD Diagnostics Acquisition

By MedTech Intelligence Staff

Today Zimmer Biomet announced the acquisition of CD Diagnostics, a move that will further strengthen the company’s competitive position in the musculoskeletal market. The two companies formed a co-development and…

Today Zimmer Biomet announced the acquisition of CD Diagnostics, a move that will further strengthen the company’s competitive position in the musculoskeletal market. The two companies formed a co-development and…

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Daniel R. Matlis, Axendia
Soapbox

Iā€™m Watson, Please State the Nature of Your Medical Emergency

By Daniel R. Matlis

…a quantum leap in web search technology. Watson goes well beyond simply answering questions. It actually learns by being exposed to large data repositories, much like people have to think…

…a quantum leap in web search technology. Watson goes well beyond simply answering questions. It actually learns by being exposed to large data repositories, much like people have to think…

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Footsteps

FDA to Develop More Guidance on Pre-Request for Designation Process

By MedTech Intelligence Staff

There’s some good news for manufacturers of combination products that deal with the confusion surrounding whether their product will be regulated as a device, drug, biologic or combination product. FDA…

There’s some good news for manufacturers of combination products that deal with the confusion surrounding whether their product will be regulated as a device, drug, biologic or combination product. FDA…

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

FDA and DOJ Working Together: No If, Ands or ā€˜Buttsā€™!

By Dr. Christopher Joseph Devine

Compliance. Charleston, SC: Amazon. FDA. (August 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. Colombian national charged for unlawfully injecting silicone into victims’ bodies. Accessed August 01, 2016. Retrieved from http://www.fda.gov/ICECI/CriminalInvestigations/ucm514579.htm…

Compliance. Charleston, SC: Amazon. FDA. (August 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. Colombian national charged for unlawfully injecting silicone into victims’ bodies. Accessed August 01, 2016. Retrieved from http://www.fda.gov/ICECI/CriminalInvestigations/ucm514579.htm…

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Medtech question

I Changed My Medical Device. Do I Need to Submit a 510(k)?

By MedTech Intelligence Staff

…not a change requires a new 510(k), harmonization of flowcharts with the text of the guidance, examples of device changes that would or would not require a new 510(k), and…

…not a change requires a new 510(k), harmonization of flowcharts with the text of the guidance, examples of device changes that would or would not require a new 510(k), and…

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Protecting Data from Hackers a Rising Concern

By Maria Fontanazza

companies and more accountability placed on a company’s board of directors when data breaches occur. As a result, companies should be implementing processes now to try to get in front…

companies and more accountability placed on a company’s board of directors when data breaches occur. As a result, companies should be implementing processes now to try to get in front…

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Ameing for Asia

Opportunities and Pitfalls in Chinaā€™s Medical Device Market

By Ames Gross

…not on the clinical trial exempt list will need local clinical studies in China in order to obtain registration approval. China has also implemented new Good Clinical Practice (GCP) standards…

…not on the clinical trial exempt list will need local clinical studies in China in order to obtain registration approval. China has also implemented new Good Clinical Practice (GCP) standards…

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

MDRs: Establish a Procedure

By Dr. Christopher Joseph Devine

…non-compliance (duh) due to a failure script a procedure, script a fully compliant procedure, failure to implement a procedure, and failure to routinely comply with a procedure (e.g., establish). That…

…non-compliance (duh) due to a failure script a procedure, script a fully compliant procedure, failure to implement a procedure, and failure to routinely comply with a procedure (e.g., establish). That…

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Joachim Schaefer
Soapbox

What Medical Breakthroughs Will the Future Bring?

By Joachim SchƤfer

…methods can be developed for an increasing number of tests. Small, Complex and Powerful Manufacturers of minimally invasive surgical instruments continue to innovate. A COMPAMED exhibitor recently presented an MRI-compatible…

…methods can be developed for an increasing number of tests. Small, Complex and Powerful Manufacturers of minimally invasive surgical instruments continue to innovate. A COMPAMED exhibitor recently presented an MRI-compatible…

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FDA

FDA Explains Role of Real-World Evidence in Regulatory Decisions

By MedTech Intelligence Staff

…would build on and leverage the vast amount of data and information collected during the treatment and management of patients.” There is a 90-day comment period for the draft guidance….

…would build on and leverage the vast amount of data and information collected during the treatment and management of patients.” There is a 90-day comment period for the draft guidance….

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