Johnson & Johnson's Lifescan division says it has received clearance from the U.S. Food and Drug Administration (FDA) for wireless integration of its OneTouch Verio Flex glucometer with WellDoc's BlueStar diabetes management platform.
U.S. President Barack Obama has formally signed the 21st Century Cures Act into law, which heralds sweeping changes to drug and medical device regulation, mental healthcare, biomedical research, and initiates several ambitious medical programs, including a "cancer moonshot" and a precision medicine initiative.
The Advanced Medical Technology Association, or AdvaMed, is forming a new digital health sector within the organization to cater to companies, developers, innovators, stakeholders, and thought leaders in this burgeoning space in healthcare.
Industry stakeholders and observers expect that the suspended medical device tax will most likely be repealed permanently by the Republican-led U.S. Congress soon after incoming U.S. President Donald Trump assumes office on January 20.
The U.S. Food and Drug Administration (FDA), via guidance that is effective immediately, will no longer require people 18 or up to secure a medical evaluation or sign a waiver before buying most hearing aids.
Fifteen officials from the U.S. Food and Drug Administration (FDA), through an article in the New England Journal of Medicine (NEJM), acknowledge the positive impact of real-world evidence on patient care, safety surveillance, and regulatory practice, but also warn of the pitfalls such evidence could entail if not vetted according to existing evidentiary standards.
Abbott says it has filed a complaint with the Delaware Court of Chancery to end its proposed deal to buy point-of-care (POC) diagnostics company Alere, which Abbott believes has lost "significant value due to numerous damaging business developments" since their $5.8 billion merger agreement was announced in late January.
Johnson & Johnson (J&J) and Smith & Nephew (S&N) led investors pouring $7 million in equity funding into OrthoSpace, which intends to use the money to support its ongoing U.S. Investigational Device Exemption (IDE) trial and commercialization activities.
The rapid proliferation of insecure internet-connected devices and systems is threatening critical healthcare, financial, transportation, energy and other infrastructure, to the extent that government and industry should be working together more closely than ever to mitigate risks.