FDA and its Japanese counterpart will soon name the two devices - one American, one Japanese - they will use in a new pilot project that could lead to faster market access for products destined for both markets, according to CDRH's Carole Carey
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The US International Trade Commission has banned smart rings from Ultrahuman and RingConn after Oura Health's patent infringement case. Ultrahuman countersued, claiming Oura infringes its intellectual property. Sales and marketing of the affected rings will cease on October 22.
A Japanese study of Watchman LAA closure devices found that leaks of any size after implantation raise the risk of stroke. The study comes shortly after the US FDA issued an early alert for the Watchman access systems.
HistoSonics’ CEO Michael Blue describes the deal as a win-win for all stakeholders and plans to use the money to expand clinical indications, as well as the global reach, for its Edison system.
A recent approval from the US FDA allowing Boston Scientific to broaden its labeling for its pulse field ablation system means more patients with one type of AFib will have access to a promising new treatment.
Signos links users to Dexcom’s Stelo for glucose readings and historic trends. The app is available in iOS and Android from the firm’s website, where it’s priced at $139 for three-month plan and $129 for a two-month plan, or online app stores.
SetPoint Medical secured US FDA approval for its vagus nerve neuromodulation device to treat RA. Now, the start-up is tasked with convincing both rheumatologist and surgeons to adopt its technology over or alongside biologic drugs. CEO Murthy Simhambhatla talks exit strategy plans.
IQWiG, Germany’s health technology assessment body, is making contingency plans in case key US resources it relies on for information retrieval, when conducting benefit assessments of new medicines, become unavailable.
