The FDA this week released a warning letter it sent to UVLrx Therapeutics over issues with an unapproved study of an intravascular catheter, citing failures to obtain approval for the trial alongside a number of other violations. The federal watchdog said that concerns were raised after an inspection performed between March 27 and April 4 […]
Catheters
FDA clears Acutus Medical’s AcQMap cardiac mapping tech
Acutus Medical said today that it won 510(k) clearance from the FDA for its AcQMap high-resolution imaging & mapping system and the 3D mapping catheter that goes by the same name. Carlsbad, Calif.-based Acutus said it plans to have the system on the U.S. market early next year. It’s designed to detect and display standard voltage-based […]
Medtronic launches pivotal trial of Intrepid TMVR system
Medtronic (NYSE:MDT) said today it launched a pivotal trial of its Intrepid transcatheter mitral valve replacement system after winning FDA investigational device exemption for the device. The 1st patient in the trial was enrolled at Milwaukee’s Aurora St. Luke’s Medical Center, the Fridley, Minn.-based company said. The Apollo trial is slated to enroll up to 1,200 […]
Spinal Singularity raises $3m in seed round
Catheter developer Spinal Singularity raised $3.1 million in a seed funding round to support its Connected Catheter designed for adult males with chronic lower urinary tract dysfunction. The funding round was led by Baker & Eastlack Ventures and joined by Western Technology Investments, YCombinator, Santa Barbara Angels, OC Service Academy Anges, SV Tech Ventures, Storm Industries, […]
The 11 most innovative medical devices of 2017
The nominees for the best medical technology of 2017 were recently announced for the 11th Annual Prix Galien USA Awards. The Galien Foundation, the host of the awards, hands out the the Prix Galien Award annually to examples of outstanding biomedical and technology product achievement designed to improve human condition. Before candidates can qualify for […]
Boston Scientific, Mayo Clinic file joint patent for self-centering TAVR cath
Boston Scientific (NYSE:BSX) and the Mayo Clinic recently filed a joint patent application for a new ‘self-centering’ catheter device as a result of a collaborative development deal the two announced last March, according to a Twin Cities Business Magazine report. The new device is being designed to help improve heart valve replacement surgery by improving the process […]
Boston Scientific closes Apama Medical buy
Boston Scientific (NYSE:BSX) today announced it closed its acquisition Apama Medical and its radiofrequency balloon catheter system designed to treat atrial fibrillation in a deal that could be worth $300 million. The deal, which Boston Scientific announced last Monday, includes an initial $175 million in cash up-front from the Marlborough, Mass.-based company and an additional $125 million in […]
7 medtech stories we missed this week: Oct. 6, 2017
From Intellijoint’s CE Mark to Patrona Medical and Kopis’ new partnership, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Intellijoint CE Mark for flagship hip navigation Intellijoint surgical announced in an Oct. 4 press release that it has received CE Mark for its Intellijoint HIP System in […]
BTG to pay $80m for Roxwood Medical
BTG (LON:BTG) said today it will pay up to $80 million to acquire specialized cardiovascular catheter developer Roxwood Medical. In the deal, U.K.-based BTG will pay $65 million upon closure of the deal and an additional $15 million upon the completion of certain future commercial milestones. BTG said it expects the deal to be accretive to […]
Adhezion Biomedical wins FDA nod for SecurePort IV cath adhesive
Adhezion Biomedical said today it won FDA 510(k) clearance for its SecurePortIV catheter securement adhesive. The Wyomissing, Penn.-based company said the SecurePortIV adhesive can be used with short-term or long-term vascular access devices to improve securement, seal catheter insertion sites, protect from catheter related blood stream infections and provide a water-resistant barrier. “SecurePortIV is the only […]
BioVentrix launches pivotal Revivent TC trial in US
BioVentrix said today it enrolled the 1st US patient in a pivotal clinical trial of its Revivent TC transcatheter ventricular enhancement system designed to treat patients with heart failure symptoms related to cardiomyopathy. The Revivent system is designed to eliminate the need for cardiopulmonary bypass or incisions in the heart by enabling the placement of […]