Cardiovascular data presented at EuroPCR 2022 demonstrates successful device performance during a TAVR procedure with no complications. CAESAREA, Israel, May 31, 2022 /PRNewswire/ — Filterlex Medical Ltd., a cardiovascular medical device startup, announced today results from a first-in-human (FIH) study demonstrating the safety, feasibility, and performance of the CAPTIS device. CAPTIS is […]
Other News
Medtronic low-profile drug-coated balloon platform receives U.S. FDA approval to treat peripheral arterial disease
Built on the market-leading IN.PACT™ Admiral™ DCB technology, the IN.PACT™ 018 DCB is engineered to cross tight lesions and designed for better deliverability§ Medtronic today announced approval from the U.S. Food and Drug Administration (FDA) for the IN.PACT™ 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter, a drug coated balloon […]
MedAlliance’s SELUTION SLR drug eluting balloon (DEB) receives FDA investigational device exemption (IDE) approval – making it the first limus DEB to be available to US patients
GENEVA, May 30, 2022 /PRNewswire/ — The SELUTION SLR (Sustained Limus Release) is a novel sirolimus-eluting balloon that provides a controlled sustained drug release, similar to a drug-eluting stent (DES). SELUTION SLR was also the first DEB (Drug Eluting Balloon) granted “breakthrough device designation” by the FDA on March 4, 2019 and further in September […]
Mezzion Pharma Receives Clear FDA Path Forward for the Approval of Udenafil for Single Ventricle Heart Disease
SEOUL, South Korea and BETHESDA, Md. , May 31, 2022 /PRNewswire/ — Mezzion Pharma Co., Ltd. (Mezzion Pharma) met with the FDA Division of Cardiology and Nephrology (DCN) on Friday, May 27th to discuss with the FDA the path forward for the regulatory approval of udenafil for the treatment of single ventricle heart disease (SVHD) in […]
AMGEN ANNOUNCES POSITIVE TOPLINE PHASE 2 DATA FOR INVESTIGATIONAL OLPASIRAN IN ADULTS WITH ELEVATED LIPOPROTEIN(a)
Study Showed Significant, Sustained Reduction in Lipoprotein(a) During Treatment Period Lipoprotein(a) Reduction was Consistent With Phase 1 Results THOUSAND OAKS, Calif., May 31, 2022 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced positive topline data from the Phase 2 OCEAN(a)-DOSE clinical study, evaluating olpasiran (formerly AMG 890) in 281 adult patients with Lipoprotein(a), or […]
Milestone Pharmaceuticals Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
MONTREAL and CHARLOTTE, N.C., May 27, 2022 /PRNewswire/ — Milestone Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced that Milestone’s Compensation Committee granted three new employees incentive stock options to purchase an aggregate of 92,000 common shares, at a per share exercise price of $5.48, […]
Toku Eyes, Developer of an AI Platform That Accurately Identifies Risk of Heart Attack Using an Eye Image, Expands to The US
With Toku Eyes’ artificial intelligence platform, the eye is not only the window to the soul — it is now a window to the state of your health AUCKLAND, New Zealand , May 31, 2022 /PRNewswire/ — Toku Eyes, the New Zealand-based developer of a multi-modal artificial intelligence platform for instant healthcare diagnostics, today announced […]
BIOMERICS ANNOUNCES EXPANSION INTO IRELAND
Expands High-Performance Balloon Design & Development Capabilities in Galway SALT LAKE CITY, May 31, 2022 /PRNewswire/ — Biomerics, the leading vertically integrated medical device contract manufacturer serving the interventional device market, has today announced the opening of a 2,000 sq. ft. Balloons & Balloon Catheters Centre of Excellence in Galway and the […]
Lexicon Resubmits New Drug Application for Sotagliflozin for the Treatment of Heart Failure
THE WOODLANDS, Texas, May 31, 2022 (GLOBE NEWSWIRE) — Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that it has resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the marketing and sale of sotagliflozin for the treatment of heart failure. The FDA has a […]
Silk Road Medical Extends Cash Runway by Securing up to $250 Million in Debt Financing
SUNNYVALE, Calif., May 31, 2022 (GLOBE NEWSWIRE) — Silk Road Medical, Inc. (Company) (Nasdaq: SILK), a company focused on reducing the risk of stroke and its devastating impact, today announced that it has entered into a new five-year loan arrangement with Oxford Finance LLC (Oxford) comprising up to a $200 […]



