News

 

FDA clears Claret Medical’s Sentinel TAVR stroke protection device for U.S. market

The FDA has cleared the use of Claret Medical’s Sentinel cerebral protection system in the U.S., making the device the … [Read more...]

Claret Medical Receives FDA Clearance to Market Sentinel Cerebral Protection System in the U.S.

SANTA ROSA, Calif.--(BUSINESS WIRE)--Claret Medical® today announced that it has received regulatory clearance from the … [Read more...]

Phase 3 Trial Data Show Use of SpaceOAR® Hydrogel Helps Maintain Erectile Function Following Prostate Cancer Radiation Treatment

Lower penile bulb radiation dose may be associated with ability to maintain sexual function and potency BEDFORD, … [Read more...]

FDA Panel Reviews Claret Medical’s Sentinel Cerebral Protection System for TAVR

February 27, 2017—Claret Medical Inc. announced that in an open public hearing of the US Food and Drug Administration's … [Read more...]

FDA Panel Says Yes to Sentinel Approval

Safety, not benefit, carries the day by Nicole Lou Reporter, MedPage Today/CRTonline.orgFebruary 23, … [Read more...]

Results from U.S. pivotal IDE trial show that Sentinel Cerebral Protection System protects patients during transcatheter aortic valve replacement

Results Simultaneously Published in Journal of the American College of Cardiology (JACC) and Presented in Late Breaking … [Read more...]

New Study Shows Definitive Neurocognitive Benefit for Patients Protected by Sentinel Cerebral Protection System During Transcatheter Aortic Valve Replacement (Tavr)

Sentinel System Shown to Protect the Vast Majority of Brain Regions from Risk of Cerebral Infarcts; Reduces Number and … [Read more...]

Augmenix wins FDA nod for SpaceOar prostate treatment

FDA clearance in hand, Augmenix is formulating U.S. commercial sales and insurance reimbursement plans for a medical gel … [Read more...]

Augmenix Announces Clearance of SpaceOAR® System

First-of-its-kind Treatment Offers Significant Clinical Benefits to Prostate Cancer Patients Undergoing … [Read more...]

Ocular Therapeutix™ Reports Positive Topline Clinical Data for the First of Two Phase 3 Clinical Trials Evaluating OTX-DP for the Treatment of Post-Surgical Ocular Inflammation and Pain

-- Topline results of the second Phase 3 clinical trial expected by the end of March -- -- NDA submission anticipated … [Read more...]

Amar Sawhney To be Inducted into Medical and Biological Engineering Elite

WASHINGTON, D.C.— The American Institute for Medical and Biological Engineering (AIMBE) has announced the pending … [Read more...]

Apama Medical Closes $17.5M in Series B Financing

CAMPBELL, Calif., Jan. 13, 2015 /PRNewswire/ -- Apama Medical, Inc., a privately held medical device company focused on … [Read more...]

Ocular Therapeutix™ Announces Top-Line Results from Phase 2 Sustained Release Dexamethasone Trial for Allergic Conjunctivitis

OTX-DP Demonstrated Statistically Significant Therapeutic Effect for Ocular Itching and Conjunctival Redness over Six … [Read more...]

Phoenix Grants AccessClosure Emerging Growth Company Award

DUBLIN, Ohio, Sept. 25, 2014 /PRNewswire/ -- AccessClosure, a Cardinal Health company, recently won the Emerging Growth … [Read more...]

CLEAN-TAVI Trial Shows Claret Medical Cerebral Protection System Dramatically Reduces Brain Lesions and Neurological Events Following Transcatheter Aortic Valve Replacement (TAVR)

Clinical Trial is First to Definitively Demonstrate That Removing Embolic Debris from Cerebral Circulation Can … [Read more...]

Fred Khosravi chosen as Emerging Medical Technologies (EMT)® Innovator of the Month

With his roots at stent pioneer Advanced Cardiovascular Systems and medical device experience spanning almost 30 years, … [Read more...]

Sustained-release eye pharmaceutical Ocular Therapeutix files for a $86 million IPO

Ocular Therapeutix, which develops and markets eye therapeutics using its sustained-release hydrogel platform, filed on … [Read more...]

QT Vascular launches IPO at 28 cents each for Catalist listing

QT Vascular has launched its initial public offering (IPO) for a Catalist listing with an offer of 196.4 million shares … [Read more...]

Cardinal Health to acquire AccessClosure for $320M

"With AccessClosure we received an outstanding management team with a proven track record to commercialize … [Read more...]

Jobs Plan Unveiled at AccessClosure, Inc. – Ro Khanna, Candidate for US Congress CA-17

Congressional candidate Ro Khanna described his jobs plan Monday at Access Closure. The plan includes teaching computer … [Read more...]