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.
Medical Device and Diagnostics Industry
Cardiovascular
Is Boston Scientific Worried About Paclitaxel and Vaginal Mesh Headwinds?
Boston Scientific celebrated a big milestone this week as FDA approved its Lotus Edge Valve, but how is the company handling recent regulatory headwinds?
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.
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.
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.
Biotronik Is a Tougher Competitor in Stents with PK Papyrus
The Lake Oswego, OR-based company received a nod from FDA for the coronary stent system in September of 2018 but launched the device this month to coincide with the release of Orsiro, its ultrathin strut DES.
TAVR Puts the Swagger Back in Mick Jagger
The Rolling Stones frontman’s recent procedure has brought a great deal of awareness to the TAVR market, which could be beneficial to device makers in the space.
A Medtech IPO Worth Doing Cartwheels Over
Silk Road Medical CEO Erica Rogers performed one of her legendary cartwheels Thursday during the company's closing bell ceremony. The company's IPO shot up 81% on its opening day, raising $120 million.
CardioFocus is Becoming a Force to Be Reckoned with in AFib Market
The Marlborough, MA-based company has secured CE mark for its HeartLight X3 and said it has seen triple-digit growth for its atrial fibrillation treatment technologies.
Potentially Disruptive Medtech Company Wins FDA Nod for HF Therapy
Impulse Dynamics, one of 16 private companies Canaccord Genuity named ‘promising’ in a January analyst report, has received approval for the Optimizer Smart System.
German Court Dismisses TMVR Patent Case Between Edwards, Neovasc
The lawsuit is related to a claim for co-inventorship of a European patent for the Tiara device.
Bet Your Toilet Seat Can't Do This!
Researchers at Rochester Institute of Technology have created a toilet seat that detects congestive heart failure.
Apple’s Watch Shows It Has ‘Heart’ in New Study
The Cupertino, CA-based company released preliminary data from the Apple Heart Study, which demonstrates the effectiveness of wearables to detect atrial fibrillation.
Meet the Robot That Can Help Perform Angioplasty
R-One is the first European robotic solution to obtain the CE mark in the field of interventional cardiology.
Abbott Wins Additional Indication for MitraClip
The Abbott Park, IL-based company’s expanded indication would allow the MitraClip to address the secondary form of mitral regurgitation and would significantly increase the amount of people with MR able to be treated by the device.
The Next Generation of Watchman Just Received CE Mark
Watchman has been a significant driver for Boston Scientific and is expected to have strong growth this year as well.