The Mountain View, CA-based company now has FDA clearance for its KardiaMobile ECG to detect BradyCardia and TachyCardia.
News & Features
Boston Scientific celebrated a big milestone this week as FDA approved its Lotus Edge Valve, but how is the company handling recent regulatory headwinds?
FDA’s approval of the Marlborough, MA-based company’s Lotus Edge Valve could represent a paradigm shift in the transcatheter aortic valve replacement market.
The regulatory agency is looking for better ways to protect patients from injuries and deaths associated with surgical staplers.
Yokneam, Israel-based Rapid Medical has raised $20 million in a series C round and will use the proceeds to help complete its IDE study.
FDA’s approval of BAROnova’s TransPyloric Shuttle device comes during a time of significant shifts and changes in the obesity treatment market.
Large retailers are planting their flags in healthcare with Amazon and Best Buy leading the charge to get into the market.
The thermomechanical behavior and processing sensitivity of nitinol raise special considerations compared to conventional metals, FDA says in new draft guidance for medical devices containing the nickel-titanium alloy.
NeuroSigma’s Monarch eTNS might be the first device to treat ADHD, but it is one of a growing number of technologies that occupy the burgeoning bioelectronic medicine space.
As artificial intelligence revolutionizes healthcare, the need for a tailored regulatory pathway for AI-based devices becomes crucial.
Ambulatory surgery centers (ASCs) offer opportunities to improve efficiencies and outcomes--can your products play a role?
The Sunnyvale, CA-based company has long been the top dog in surgical robotics but increased competition is right around the corner for the firm.
Seeing firsthand the limitations of current overactive bladder therapies, a urogynecology surgeon invented a wearable, non-surgical solution to the problem.
Neovasc said it had resolved the three claims of correction of patent inventorship made by Irvine, CA-based Edwards Lifesciences.
In a new report, DRG experts have highlighted four medtech innovations that they see tearing up the script.