News

AliveCor’s New Indications Help Consumers Understand Their Hearts

The Mountain View, CA-based company now has FDA clearance for its KardiaMobile ECG to detect BradyCardia and TachyCardia.

Boston Sci Ends TAVR ‘Duopoly’ Held by Medtronic and Edwards

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.

FDA Cracks Down on Surgical Staplers

The regulatory agency is looking for better ways to protect patients from injuries and deaths associated with surgical staplers.

Financing Paves Way for Rapid to Enter the U.S. Market

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.

There’s a New Weight-Loss Device in Town and TPS Is Its Name

FDA’s approval of BAROnova’s TransPyloric Shuttle device comes during a time of significant shifts and changes in the obesity treatment market.

Haven’t You Heard? Best Buy and Telehealth Are a Thing Now

Large retailers are planting their flags in healthcare with Amazon and Best Buy leading the charge to get into the market.

FDA Drafts Guidance for Medical Devices Containing Nitinol

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and processing sensitivity of nitinol raise special considerations compared to conventional metals, FDA says in new draft guidance for medical devices containing the nickel-titanium alloy.

Monarch Becomes the 1st FDA-Cleared Device for ADHD

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.

Intuitive Falls Short of Expectations in 1Q19

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.

Finally, a Wearable Neuromodulation Device for Overactive Bladder

Seeing firsthand the limitations of current overactive bladder therapies, a urogynecology surgeon invented a wearable, non-surgical solution to the problem.

No More Patent Drama Between Neovasc and Edwards?

Neovasc said it had resolved the three claims of correction of patent inventorship made by Irvine, CA-based Edwards Lifesciences.

AngioDynamics to Divest its Fluid Management Portfolio

Medline Industries will pick up the Namic Fluid Management Portfolio for $167.5 million.

Abbott Has Midas Touch with Its 1Q19 Earnings

The Abbott Park, IL-based has had a solid foundation of success dating back to the closure of the St. Jude Medical acquisition.

Learning to Walk Again

A new exo-suit technology from ReWalk aims to help stroke survivors regain their normal gait patterns.

FDA Flips the Switch on Pelvic Mesh Manufacturers

FDA has ordered Boston Scientific and Coloplast to stop selling surgical mesh intended for transvaginal repair of pelvic organ prolapse. Patient advocates say the action was not made soon enough and does not go far enough, but it is a step in the right direction.