…Clinton’s campaign has not commented on one of the biggest issues brought on by the ACA that is affecting medical device companies: The 2.5% medical device excise tax, which was…
…Clinton’s campaign has not commented on one of the biggest issues brought on by the ACA that is affecting medical device companies: The 2.5% medical device excise tax, which was…
…11% increase compared to the prior year period. According to a company release, Boston Scientific reported the following growth: Business Units MedSurg: 15% Cardiovascular: 13% Rhythm Management: 4% Geographies United…
…11% increase compared to the prior year period. According to a company release, Boston Scientific reported the following growth: Business Units MedSurg: 15% Cardiovascular: 13% Rhythm Management: 4% Geographies United…
Today Medtronic announced FDA approval of its CoreValve Evolut, the largest transcatheter aortic valve replacement (TAVR) available in the United States. The R 34-mm valve is indicated to treat severe…
Today Medtronic announced FDA approval of its CoreValve Evolut, the largest transcatheter aortic valve replacement (TAVR) available in the United States. The R 34-mm valve is indicated to treat severe…
…comparison to the markets in the United States, EU, and Japan. For example, Vietnam, Indonesia and Thailand all import more than 85% of their medical devices. In other words, not…
…comparison to the markets in the United States, EU, and Japan. For example, Vietnam, Indonesia and Thailand all import more than 85% of their medical devices. In other words, not…
Today the FDA has announced the establishment of a website through which anyone can report an allegation of regulatory misconduct. Examples of allegations include promoting or advertising a device outside…
Today the FDA has announced the establishment of a website through which anyone can report an allegation of regulatory misconduct. Examples of allegations include promoting or advertising a device outside…
…distribution centers, helping companies to be more agile. Image courtesy of UPS. MTI: What technologies can companies use to streamline their supply chain processes? Cannon: The best technologies for driving…
…distribution centers, helping companies to be more agile. Image courtesy of UPS. MTI: What technologies can companies use to streamline their supply chain processes? Cannon: The best technologies for driving…
…C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (June 2016). 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. (June 2016). Inspections, Compliance, Enforcement, and…
With the proclamation of October as National Cybersecurity Awareness Month, FDA is encouraging medical device manufacturers to brush-up on their best practices and engage in good cyber hygiene. “As medical…
With the proclamation of October as National Cybersecurity Awareness Month, FDA is encouraging medical device manufacturers to brush-up on their best practices and engage in good cyber hygiene. “As medical…
…we look at 2016 and it comes to completion, we’ll see a pretty impressive growth number.” Shareholder-friendly actions. Many companies have focused on stock buybacks and enhancing dividends, all while…
…we look at 2016 and it comes to completion, we’ll see a pretty impressive growth number.” Shareholder-friendly actions. Many companies have focused on stock buybacks and enhancing dividends, all while…
FDA has released the draft guidance Software as a Medical Device (SaMD): Clinical Evaluation with the intention of “establishing the scientific validity, clinical performance, and analytical validity for a SaMD,”…
FDA has released the draft guidance Software as a Medical Device (SaMD): Clinical Evaluation with the intention of “establishing the scientific validity, clinical performance, and analytical validity for a SaMD,”…
