Scott Gottlieb, FDA

FDAā€™s Innovation Initiative Aims to Prevent Regulatory Barriers

By MedTech Intelligence Staff

…and benefits.” – Scott Gottlieb, M.D., FDA commissioner In a blog on FDA Voice, Gottlieb emphasizes the cost component of developing technology and patient ability to access them. The 21st…

…and benefits.” – Scott Gottlieb, M.D., FDA commissioner In a blog on FDA Voice, Gottlieb emphasizes the cost component of developing technology and patient ability to access them. The 21st…

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ZimmerBiomet

Zimmer Biomet CEO David Dvorak Resigns

By MedTech Intelligence Staff

…musculoskeletal healthcare. Through a combination of organic growth and strategic acquisitions, Zimmer Biomet’s revenue has doubled and the Company has established a leading portfolio of technologies, solutions and personalized services.”…

…musculoskeletal healthcare. Through a combination of organic growth and strategic acquisitions, Zimmer Biomet’s revenue has doubled and the Company has established a leading portfolio of technologies, solutions and personalized services.”…

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CARDIS device

Diagnose Heart Disease in One Click

By MedTech Intelligence Staff

…the CARDIS device can detect important information about the heart. Image courtesy of Photonics 21. “Our device employs the latest photonics technology, allowing a user to make measurements of the…

…the CARDIS device can detect important information about the heart. Image courtesy of Photonics 21. “Our device employs the latest photonics technology, allowing a user to make measurements of the…

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INSPIRIS valve, Edwards Lifesciences

Edwards Lifesciences Receives FDA Approval for Its New Class of Heart Valves

By MedTech Intelligence Staff

INSPIRIS valve with inside view of VFit technology. Image courtesy of Edwards Lifesciences. Last week FDA approved Edwards Lifesciences Corp.’s Inspiris Resilia aortic valve, which the company is calling a…

INSPIRIS valve with inside view of VFit technology. Image courtesy of Edwards Lifesciences. Last week FDA approved Edwards Lifesciences Corp.’s Inspiris Resilia aortic valve, which the company is calling a…

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Dignicap Scalp Cooling System, breast cancer, chemotherapy

FDA Expands Clearance of Cooling Cap to Minimize Hair Loss During Chemotherapy

By MedTech Intelligence Staff

…by Swedish company Dignitana AB, the computer-controlled device circulates liquid through a snug silicone cap to cool the scalp during chemotherapy. The cooling constricts blood vessels in the scalp to…

…by Swedish company Dignitana AB, the computer-controlled device circulates liquid through a snug silicone cap to cool the scalp during chemotherapy. The cooling constricts blood vessels in the scalp to…

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

FDA Reviewed Your Response, and Itā€™s Not Adequate

By Dr. Christopher Joseph Devine

…system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (May 2017). Inspections, Compliance, Enforcement, and Criminal Investigations. International Medsurg Connection, Inc. Accessed June 25, 2017. Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm558368.htm…

…system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (May 2017). Inspections, Compliance, Enforcement, and Criminal Investigations. International Medsurg Connection, Inc. Accessed June 25, 2017. Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm558368.htm…

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Checkbox

Paperless Manufacturing: Five Key Benefits for Medical Device Manufacturers

By Sean O’Sullivan

With the ever-growing complexity of medical devices, manufacturers need to embrace changes in the industry or they will find themselves left behind as competitors make strides in this new era….

With the ever-growing complexity of medical devices, manufacturers need to embrace changes in the industry or they will find themselves left behind as competitors make strides in this new era….

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FDA

FDA Allows Beckman Coulter to Market Leukemia Test, ā€˜Major Step Forwardā€™

By MedTech Intelligence Staff

…by a study comparing the test’s results to alternative detection methods used by clinical sites. In addition to the authorization, the agency is establishing special controls that explain its expectations…

…by a study comparing the test’s results to alternative detection methods used by clinical sites. In addition to the authorization, the agency is establishing special controls that explain its expectations…

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Boston Scientific

Boston Scientific FY 2016 Revenue Hits $8.4 Billion

By Maria Fontanazza

…a 6–8% CAGR for 2018–2020. For fiscal year 2016, the company reported $8.4 billion in revenue and 12% operational growth. The following is a breakdown of the company revenue and…

…a 6–8% CAGR for 2018–2020. For fiscal year 2016, the company reported $8.4 billion in revenue and 12% operational growth. The following is a breakdown of the company revenue and…

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Philips

Philips to Acquire Spectranetics for $2.2 Billion

By MedTech Intelligence Staff

Royal Philips has entered into a definitive merger agreement with Spectranetics to buy the company for $2.15 billion. Announced on Wednesday, the deal is expected to strengthen Philips’ image-guided therapy…

Royal Philips has entered into a definitive merger agreement with Spectranetics to buy the company for $2.15 billion. Announced on Wednesday, the deal is expected to strengthen Philips’ image-guided therapy…

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