Yearly Archives: 2019

LaunchPad Medical Accelerates Enrollment in its First-In-Man Clinical Study

his study constitutes the first clinical use of Tetranite®, a bone adhesive biomaterial. The purpose of the study is to show the safety and efficacy of Tetranite in immediately stabilizing dental implants following tooth extractions and its ability to obviate a costly, complex, and lengthy bone grafting procedure to accelerate the overall treatment timeframe for the many patients who suffer tooth loss.

FDA Grants ‘Breakthrough’ Designation to Eko’s ECG-based Low Ejection Fraction Screening Algorithm, Designed to Improve Detection of Heart Failure

The algorithm analyzes 15 seconds of ECG data collected from the Eko DUO digital stethoscope during a physical exam and helps identify reduced Left Ventricular Ejection Fraction (LVEF), a measure commonly used to diagnose patients with heart failure.

Terason Partners with AmCad BioMed

Terason reports the partnership addresses a strong market need for more efficient solutions that help physicians evaluate the risk of OSA, a disorder that affects over 425 million people worldwide.

Velano Secures Additional Funding

Latest funding caps year of groundbreaking milestones for transformative vascular access company; new capital will be used to meet rapidly growing hospital and patient demand.

Anatomage Revives Heart Beat of a Cadaver

Anatomage develops digital cadavers, which are available on the Anatomage Table. These cadavers are accurately reconstructed from preserved human bodies and serve as precise references for anatomical studies.

RAPID AI Enhanced Advanced Medical Imaging for Stroke

The RAPID artificial intelligence framework helps to quantify brain lesions and extend the window of potential stroke intervention from six hours after onset to up to 24 hours, for patients with salvageable brain tissue. RAPID provides physicians with fast, fully automated, and easy-to-interpret imaging that facilitates clinical decision-making around stroke.

ControlRad: New Leadership Team Announcements

Company reports these industry veterans bring considerable experience leading businesses and introducing new products in the medical device industry.

TransBiotec: Closes on $1.0 Million Financing

This initial $1.0 million is the first tranche of a $2.0 million offering; the Company hopes to close a second tranche of up to $1.0 million within the next 90 days.

Tekni-Plex Forms Tekni-Plex Medical Business Unit

The business unit, which will facilitate the supply of mission-critical, high-value components, materials, and solutions to medical device manufacturers worldwide.

Prasco Launches the Authorized Generic of NuvaRing® in the USA

Etonogestrel/Ethinyl Estradiol Vaginal Ring is a small, flexible vaginal ring used by women to prevent pregnancy.

Sofregen Medical Raises $8 Million in Series B Funding Round

The company is developing an advanced platform of products based on silk protein - also known as fibroin - that has been shown to have unique properties for tissue support and regeneration.

ChromaCode Raises $28 Million in Series C Financing

The round was led by Northpond Ventures, a global firm dedicated to science and technology headquartered in Bethesda, Maryland.

ACRO Announces New Member and 2020 Officers

ACRO is also announcing the onboarding of its newest member, Signant Health, its sixth technology member. Signant is focused on using technology to connect research programs to patients for clinical research and pharmaceutical development.

PureTech Health Affiliate Gelesis Announces Partnership with Ro to Support US Commercialization of Plenity TM

In addition to collaborating with traditional healthcare providers, Gelesis will leverage Ro’s nationwide telehealth services to make Plenity available to patients who don’t have an established healthcare provider or prefer a remote interaction.

Beatty Marketing & Sales Acquired by Aspen Surgical

Aspen Surgical reports the acquisition will advance leadership in orthopedic disposables.

VolitionRx Limited Reaches Agreement to Acquire Octamer GmbH

The aggregate purchase price is €650,000 Euros (approximately $725,000), consisting of €350,000 cash and approximately 73,000 shares of common stock of Volition, for 100% of the outstanding shares of Octamer.

Peripheral Orbital Atherectomy System With GlideAssist® Introduced in Europe

The 1.25 Micro Crown is designed with flexibility for tortuous vessels and tight bends below the knee.

World’s First Single-Use Duodenoscope, EXALT™ Model D Receives FDA Clearance

The EXALT Model D Duodenoscope is the first and only FDA cleared single-use (disposable) duodenoscope on the market and was granted Breakthrough Device Designation from the FDA to ensure patients and healthcare providers have timely access to this device.

Innovatus Imaging Engineers New Repair Solutions for the Philips X5-1

Expands testing and repair capabilities.

Primary Endpoint Achieved in Randomized, Controlled Trial of Digital Therapeutic AKL-T03 in Major Depressive Disorder

Results of the study were presented yesterday at the 58th Annual Meeting of the American College of Neuropsychopharmacology.

Ibex Medical Announced Deployment of the Ibex Second Read™ System for Breast

The system uses an artificial intelligence (AI) powered algorithm to analyse cases in parallel to pathologists and compares between the pathologists' diagnoses and the algorithm's findings, subsequently alerting in case of discrepancies with high clinical importance (e.g. a missed cancer).

Nihon Kohden Launches Life Scope® SVM-7200 Series Vital Sign Monitor

The monitor is designed for outpatient facilities and beds that traditionally are not continuously monitored.

Beat Stress Through New Wearable Device

Developed by physicians and neuroscientists at the University of Pittsburgh, Apollo’s gentle waves of vibration signal safety to the body through your sense of touch and rapidly improve heart rate variability, a key metric of health and recovery.

LimFlow Reports First Patient Enrolled in PROMISE II U.S. Pivotal Study

The successful first case was performed by Mark Archie, MD, principal investigator for the PROMISE II trial at Harbor-UCLA Medical Center, and Nina Bowens, MD, sub-investigator for the PROMISE II trial at Harbor-UCLA Medical Center.

Charles F. D’Agostino Appointed to RedHawk BOD

Mr. D'Agostino is the retired founder and Executive Director of the LSU Innovation Park and the Louisiana Business & Technology Center ("LBTC") at Louisiana State University and has been actively involved in entrepreneurship, economic development, and technology transfer for the last 30 years