Medtronic‘s (NYSE:MDT) 2.0-mm Resolute Onyx drug-eluting stent has won FDA approval and is set to launch in the U.S., making it the smallest device of its kind on the market. The stent is designed to treat patients with coronary artery disease who have small vessels. Interventional cardiologists often face challenges treating this patient group with […]
Reva Medical wins CE Mark for bioresorbable Fantom Encore scaffold
Reva Medical (ASX:RVA) has won CE Mark clearance for its thin strut Fantom Encore bioresorbable, drug-eluting scaffold. The sirolimus-eluting vascular scaffold, which is made from Reva’s Tyrocore polymer, features a 95-micron strut profile and x-ray visibility. Get the full story at our sister site, Drug Delivery Business News.
Medtronic wins sensor nod from FDA for MiniMed 670G auto insulin tech
The FDA has cleared Medtronic‘s (NYSE:MDT) Guardian sensor, part of the medtech titan’s MiniMed 670G automated insulin delivery system, to be worn on the upper arm. The device is Medtronic’s newest and most accurate continuous glucose monitor, the company touted, and is the only sensor approved by the FDA for use with a hybrid-closed loop system […]
South Korea approves Apollo Endosurgery’s Orbera weight loss balloon
Apollo Endosurgery (NSDQ:APEN) has won approval in South Korea for its Orbera intragastric weight-loss balloon system. The Orbera system includes a silicone balloon that is placed into a patient’s stomach endoscopically and filled with saline. The balloon is designed to lessen the patient’s stomach capacity and thereby reduce the amount of food that the patient […]
Novo Nordisk touts promising results from late-stage trial of oral diabetes med
Setting the stage for a battle with rival Eli Lilly (NYSE:LLY), Novo Nordisk (NYSE:NVO) reported data this week from a late-stage trial of its oral formulation of semaglutide, a medication for people with Type II diabetes. The GLP-1 agonist is traditionally administered via injection. Both insulin-makers have approved versions of the injectable semaglutide, but Novo Nordisk is the first […]
Needle-free flu vaccine will be back in clinics next flu season
MedImmune‘s FluMist, the only needle-free flu vaccine available in the U.S., has regained the support of an expert panel at the Centers for Disease Control & Prevention. The Advisory Committee on Immunization Practices has voted to recommend the nasal spray’s use, reversing a two-year-old decision to keep the product out of clinics due to efficacy […]
Deerfield-backed blank-check firm’s IPO raises $250m for healthcare plays
DFB Healthcare Acquisitions (NSDQ:DFBHU) said today that it closed a $250 million initial public offering. The firm’s IPO included 25,000,000 units priced at $10.00 apiece. Each unit consisted of one share of common stock and one-third of one warrant. The company said it expects its common stock to be listed on the Nasdaq under the […]
FDA clears Endomag’s Magseed marker for long-term and soft tissue implantation
Surgical guidance company Endomag said today that its Magseed magnetic marker won 510(k) clearance from the FDA, extending the product’s indication to include the marking of soft tissue and long-term implantation. The company’s Magseed device is the only wire-free lesion localization device on the market that can be implanted into any soft tissue with no […]
Collagen Solutions jumps on positive study data
Shares in Collagen Solutions (LON:COS) rose this week after the U.K.-based company touted positive data from an eight-year study of 15 patients who received ChondroMimetic implants to repair cartilage defects in their knees. The company plans to apply for CE Mark clearance in the European Union for its ChrondroMimetic implant based on the results from […]
NaviGate touts implantation for Gate transcath tricuspid valve replacement
NaviGate Cardiac Structures Inc. said today that earlier this month, its catheter-guided Gate valved-stent bioprosthesis became the first orthotopic valve replacement in Canada to treat severe tricuspid regurgitation. The implantation was done at the Quebec Heart and Lung Institute, lead by interventional cardiologists Dr. Josep Rodes-Cabau and Dr. Francois Dagenais. The 79-year-old male patient who […]
Valeritas inks distribution deal in Italy for V-Go insulin delivery device
Valeritas (NSDQ:VLRX) has inked an exclusive distribution deal with Movi SpA for the commercialization of its V-Go wearable insulin delivery device in Italy. According to the terms of the deal, Movi will market and sell the V-Go device to diabetes clinics and patients in Italy, while Valeritas will remain responsible for the product’s development, regulatory approval […]