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 It’s Not Adequate

By Dr. Christopher Joseph Devine

…robust correction plan. The FDA does not expect everything to fixed immediately; however, they do expect the compliance issues to be resolved quickly. If you make commitments to the FDA…

…robust correction plan. The FDA does not expect everything to fixed immediately; however, they do expect the compliance issues to be resolved quickly. If you make commitments to the FDA…

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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, ‘Major Step Forward’

By MedTech Intelligence Staff

Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health at CDRH called it a “major step forward for the hematology-oncology community”. FDA is allowing Beckman…

Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health at CDRH called it a “major step forward for the hematology-oncology community”. FDA is allowing Beckman…

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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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magnifying glass

Market Research Helps Device Companies Do the Homework

By Maria Fontanazza

…When approaching research, Robert Kaminsky, president and CEO of MedSpan Research recommends that companies first look at publicly available data (also known as syndicated research). If syndicated research studies out…

…When approaching research, Robert Kaminsky, president and CEO of MedSpan Research recommends that companies first look at publicly available data (also known as syndicated research). If syndicated research studies out…

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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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