Yearly Archives: 2017

Centers Commence Enrollment in KNOCOUT PE Study to Measure the Impact of Shorter, Even Safer EKOS® Therapy Protocols for Pulmonary Embolism

12/14/17: BTG plc (LSE: BTG), the global specialist healthcare company, today highlights the commencement of the KNOCOUT PE study.

Intersect ENT Announces FDA Approval of SINUVA™ Sinus Implant, a New In-Office Treatment Option for Recurrent Nasal Polyps

12/11/17: Intersect ENT, Inc. today announced that it has received approval from the U.S. Food and Drug Administration for the SINUVA™ (mometasone furoate) Sinus Implant, a new targeted approach to treating recurrent nasal polyp disease in patients who have had previous ethmoid sinus surgery.

Bertin and Zymo Research Announce New Collaboration

12/8/17: Zymo Research Corp. and Bertin announce a collaboration that ensures the sample lysis step in the microbiome workflow is complete and unbiased.

Corindus Partners with Houston Methodist DeBakey Heart & Vascular Center to Launch Premier Robotic Training Site for Physicians

12/1/17: Corindus Vascular Robotics, Inc. (NYSE American: CVRS), a leading developer of precision vascular robotics, announced today that Houston Methodist DeBakey Heart & Vascular Center, a leading cardiovascular center located in the Texas Medical Center, has launched the first vascular robotic program in the Houston area with the installation of two CorPath GRX Systems.

Updated TCAR Data from Silk Road Medical’s ROADSTER 1 and 2 Studies Presented at VEITHsymposium

“TCAR is the next step,” said Dr. Peter Schneider, Chief of Vascular Therapy at Hawaii Permanente Medical Group and Kaiser Foundation Hospital Honolulu, and National Co-Principal Investigator of the ROADSTER 2 post-market study. “Carotid endarterectomy has been perfected over 50 years, but no matter how good it gets, it has certain inherent challenges that aren’t ever going to go away. My attitude now has really flip-flopped from that of tried and true surgery to what I think is the future of carotid artery repair.”

Nautilus Medical Collaborates with Google Cloud for Secure Radiology Storage and Image Exchange

Nautilus Medical in collaboration with Google Cloud Technology Partner program is releasing a more robust image exchange and DICOM and patient information storage and distribution system. The release will be available at the 2017 RSNA Show at Chicago's McCormick Place November 26th-30th.

Medicrea Receives FDA Clearance for 3D-Printed Titanium Interbody Devices and Introduces AdapTEK™ Surgeon-Adaptive Technology

The Medicrea® Group (Euronext Growth Paris: FR0004178572 - ALMED), pioneering the convergence of healthcare IT and next-generation, outcome-centered device design and manufacturing with UNiD™ Adaptive Spine Intelligence™ (ASI) technology, announced today the Company has received Food and Drug Administration (FDA) clearance for its IB3D™ range of 3D-printed Titanium interbody devices and the introduction of AdapTEK™, its surgeon-adaptive technology.

Medtronic Announces FDA Approval and U.S. Launch of Next Generation Pacemakers

Medtronic plc (NYSE: MDT) today announced U.S. Food and Drug Administration (FDA) approval and U.S. commercial launch for its portfolio of Azure(TM) pacemakers with BlueSync(TM)technology. Available in both single chamber and dual chamber models, the Azure XT MRI and Azure S MRI pacemakers offer improved longevity, estimated at 13.7 years (dual chamber) or 27 percent longer than its predecessor,1 so patients likely need fewer device replacements. The new pacemakers also allow patients to have MRI (magnetic resonance imaging) scans in either 1.5 or 3 Tesla (T) machines.

TransEnterix Announces Senhance US Sale Agreement With Florida Hospital

11/13/17: TransEnterix, Inc. (NYSE American: TRXC), a medical device company that is pioneering the use of robotics to improve minimally invasive surgery, today announced that Florida Hospital entered into an agreement to purchase the Company’s Senhance™ Surgical Robotic System.

Tepha Inc. Announces Regenerative Medicine Recent Developments and R & D Initiatives

11/9/17: Tepha Inc., a developer and marketer of implantable medical devices based on its proprietary P4HB™ resorbable polymer technology, announced today recent developments and R & D initiatives in the field of regenerative medicine scaffolds for the repair or replacement of compromised human tissue.

First US FDA Submission of Wearable Drug-Device Combination Product Based on Sensile Medical’s SensePatch Drug Delivery Technology

Sensile Medical, a global leader in Large Volume Injector devices based on the cost-efficient and highly accurate SenseCore micro pump technology platform, today announced that scPharmaceuticals has submitted Furosemide for s.c. administration together with Sensile's patch pump delivery system for approval with the FDA.

Medtronic Receives CE Mark for the World’s Smallest Fully Implantable Spinal Cord Stimulator and Announces European Launch of the Intellis Platform

One in five adults in Western Europe suffers from chronic pain, a devastating condition with a costly personal and societal impact.1 Chronic pain can negatively impact all aspects of a person's life - relationships, work productivity and activities of daily living, yet it remains under-recognized and undertreated

Maxx Orthopedics Announces First International Surgeries of its Freedom® PCK Revision System

Maxx Orthopedics, Inc., today announced that the Freedom® PCK Revision System has now been made available globally, with the first surgeries performed in India and several Gulf countries, including Oman and the United Arab Emirates.

Medtronic Unveils Strong Early Outcomes for the Intrepid Transcatheter Mitral Valve Replacement (TMVR) System

Medtronic plc (NYSE:MDT) today presented positive data for its self-expanding Intrepid(TM) transcatheter mitral valve replacement (TMVR) system in patients with severe, symptomatic mitral valve regurgitation.

Veracyte Announces Presentation of New Clinical Utility Showing Percepta Classifier Reduces Invasive Procedures in Lung Cancer Diagnosis

Veracyte, Inc. today announced that data from a prospective clinical utility study show that use of the company’s Percepta Bronchial Genomic Classifier reduces invasive procedures by greater than 50 percent in lung cancer screening and diagnosis.

TherOx AMI Study for Improved Patient Outcomes Meets Primary Endpoint

The purpose of this study was to confirm the safety and effectiveness of Supersaturated Oxygen (SSO2) Therapy in the treatment of anterior AMI patients who have undergone successful percutaneous coronary intervention with stenting within six hours of experiencing AMI symptoms.

AHA/ACC/HRS Publish New Guidelines on the Wearable Cardioverter Defibrillator for Patients at Risk of Sudden Cardiac Death

The American Heart Association (AHA), American College of Cardiology (ACC), and Heart Rhythm Society (HRS) have issued guidelines for the wearable cardioverter defibrillator (WCD) that include recommended use for a wide range of patients at risk of sudden cardiac death (SCD), including those who have recently suffered a myocardial infarction (MI), with or without revascularization, and those with a newly diagnosed non-ischemic dilated cardiomyopathy.

PROCEPT BioRobotics Announces Milestones in Europe

PROCEPT BioRobotics, a Silicon Valley surgical robotics company developing novel and disruptive technologies to treat prostate disease, announced that the first commercial Aquablation® procedures have been completed in Germany. Additionally, the company has initiated the FRANCAIS WATER clinical trial, a necessary first step in gaining reimbursement for the company’s AquaBeam® System in France.

Viveve Launches GENEVEVE™ by Viveve Treatment in Canada

Viveve Medical, Inc. (NASDAQ: VIVE), a medical technology company focused on women's health and wellness, today announced the launch of direct sales of the GENEVEVE treatment to physicians and healthcare providers in Canada. Delivered by the internationally patented Viveve® System, the GENEVEVE treatment improves sexual function by treating the vaginal introitus, after vaginal childbirth.

OrbusNeich’s COMBO™ Dual Therapy Stent Demonstrates Non-inferiority vs the Market Leading XIENCE™ Everolimus Eluting Stent

New results from the HARMONEE Japan/US Registration Trial, reported by OrbusNeich today in the First Report Investigations session at the 29th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, demonstrate that the COMBO™ Dual Therapy Stent (DTS) compares favorably to the market leading option for treating patients with significant ischemic heart disease.

HyperMed Imaging Announces Cardiology Group as Early Adopter For Its New HyperView Product

Per the company, the HyperView System is FDA cleared, and it represents a new standard of performance when assessing tissue oxygenation and perfusion in patients with potential circulatory compromise.

Analytics 4 Life to Present New Clinical Data on Novel Cardiac Imaging Technology Using Machine-Learned Algorithms at the Transcatheter Cardiovascular Therapeutics 2017 Scientific Symposium

"We are encouraged by these initial results which suggest that our cardiac imaging technology has clinically significant utility in assessing coronary artery disease (CAD), without the need for radiation, exercise or pharmacologic stress," said Don Crawford, CEO, Analytics 4 Life. "Conventional CAD detection pathways may be less accurate in specific populations, such as obese, elderly and female patients, but these early results show a promising potential for alternative technology."

MedX Health Corp Completes the Design Phase of its Telemedicine Platform

Regarding this new milestone, Robert von der Porten, President and Chief Executive Officer of MedX commented, “We are very excited about reaching this important milestone with Blanc Labs as we believe that this telemedicine platform is a game-changer for MedX and its growth trajectory, and ultimately for people – no matter where they live – who will be able to get their moles and lesions accurately assessed by a dermatologist without having to endure lengthy wait times to determine if there is cancer present." 

Young Entrepreneurs Receive FDA Clearance for Medical Device Poised to Disrupt Newborn Care Market

NeoLight announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration to market the Skylife™ portable phototherapy system. The Skylife device delivers a narrow band of high-intensity blue light via blue light emitting diodes to provide treatment for neonatal unconjugated hyperbilirubinemia (jaundice).

HighLife Closes €12.3 Million Financing Round Led by Sofinnova Partners

HighLife SAS, an early-stage medtech company focused on the development of a unique trans-catheter mitral valve replacement system to treat patients suffering from mitral regurgitation, announced today the closing of a €12.3 million investment round led by Sofinnova Partners which becomes the main investor in the company. HighLife had previously secured financing from LivaNova PLC, which also participated in this financing round along with Georg Börtlein, the CEO and founder of HighLife.