Medical Device News Magazine

Welcome! Medical Device News Magazine reports the latest medical device industry news, clinical trials and updates, product launches, profiles of device companies, acquisitions, executives on the move, non-profit and medical society news and more. Read by practicing medical specialists, industry executives, investors and other allied health professional. We invite you to visit Medical Device News Magazine daily.

Friday, October 18, 2019
C•MVP by COAST Systems combines powerful computerized maintenance management software with expert mold management advice to help manufacturers gain total control over the integrity, reliability, and whereabouts of their physical mold assets.
During pre-transfusion testing, lab professionals routinely encounter complex patient samples that require extended antigen typing.
Spark Biomedical's neurostimulation solution is a small wearable device that delivers mild electrical stimulation through the skin around the ear, targeting cranial nerve branches. The system is powered by a small rechargeable battery designed to deliver therapy throughout the 10-day treatment period.
The positive impact of artificial intelligence technology has been demonstrated in many fields, including that of radiology. Indeed, AI can help radiologists increase productivity, improve clinical decisions and, ultimately, provide high quality care when the technology is tightly managed and smartly integrated in the workflow.
MagicTouch – PTA is the only commercially available and CE certified Sirolimus coated balloon catheter for peripheral arterial diseases.
The CarboClear® VBR System joins the FDA cleared CarboClear® Pedicle Screw and CarboClear® Fenestrated Pedicle Screw Systems.
Closing of the offering is expected to occur on October 21, 2019, subject to customary closing conditions.
The new Stimpod system and EMG sensor accessory will be exhibited at the American Society of Anesthesia Annual Meeting Oct. 19-21 in Orlando, Florida, alongside the company's entire Stimpod portfolio for anesthesia.
The study is a prospective, multi-center, multi-phase, evaluator-blinded study designed to evaluate the safety and effectiveness of Renuvion technology when used to improve the appearance of lax tissue in the neck and submental region.
The new kit shown to achieve over 90% correlation rate between biopsied embryos and testing spent culture media.
Yale New Haven Hospital (YNHH) is the first hospital to use the Hyperfine POC MRI system on patients, as part of a 2-year study in conjunction with the American Heart Association. This study aims to overcome barriers that have prevented the routine use of MRI on unstable neurology intensive care unit patients who cannot be transported.
The CHEETAH study, a prospective, multi-center U.S. study to evaluate the safety and performance of the Indigo System with CAT RX Aspiration Catheter in the coronary vessels. Introduced in 2018, as part of the Indigo Aspiration System, the Indigo CAT RX Aspiration Catheters and Indigo Separator™ 4 are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature. 
The award comes through the NIH Helping to End Addiction Long-term Initiative, or the NIH HEAL Initiative, which aims to improve treatments for chronic pain, curb the rates of opioid use disorder and overdose, and achieve long-term recovery from opioid addiction.
The Injectsense IOP-Connect system creates an organ-to-cloud data connection that enables the clinician to assess glaucoma therapy effectiveness at any time.  The system is expected to provide unprecedented visibility into the IOP profile of the patient over time, and into previously unobserved changes that may affect glaucoma progression.
EXOGEN uses natural bone healing process and promote fracture healing. It also has an 86% heal rate for fractures not healing on their own and provides 38% faster healing of fresh fractures.
The FDA Breakthrough Device Program is intended to help patients receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. Under the program, the FDA will provide Medtronic with priority review and interactive communication regarding device development and clinical trial protocols, through to commercialization decisions.
An EFS for a medical device is similar to a phase 1 study for a drug or biologic and as such this trial will enroll a small number of patients with advanced head and neck cancer who cannot be treated with surgery or radiation.
The capital raised will fund a large-scale, pre-launch, phase 4 trial for AtopX™ Eczema Emulsion, with enrollment scheduled to begin in Q1, 2020.
This regulatory approval of the Biovitals™ Analytics Engine is part of FDA's growing recognition of machine-learning and AI in the Software as a Medical Device category.
The Series B round, which was led by Questa Capital, will be used for fueling the commercial launch of the innovative ControlRad Trace system.
Finia is a fully automated, modular, functionally closed system that creates the final formulation of cell and gene therapies and divides them into user-defined doses for patients. The technology automates a process that is currently manual and labor-intensive with the added risk of error.
As a leading sensor technology specialist in medical technology SONOTEC easily meets the latest EMC product standard IEC 60601-1-2 (Edition 4) for the SONOFLOW CO.56 Pro FlowBubble Sensor. In addition to Edition 4, the sensors meet IEC 60601-1 (Edition 3) and IEC 61157, the standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment, and RoH's 2011/65/EU to guarantee CE compliance.
The randomized, multi-center study called LIGHTSITE III enrolled and treated the first patient at Cumberland Valley Retina in Hagerstown, Maryland. The United States study is being conducted in leading retinal centers throughout the United States. The study will enroll approximately 100 patients suffering from dry AMD and treat them over the course of two years. In addition to demonstrating safety, key efficacy endpoints include visual acuity, contrast sensitivity and reduction of drusen deposits.
The funds will be used to support the landmark PROACTIVE-HF IDE clinical trial of the Cordella® Pulmonary Artery Sensor System (Cordella Sensor) and commercialization of the Cordella® Heart Failure System (Cordella System).
This is the highest level of recommendation from the NICE committee and means that there is enough evidence for surgeons experienced in managing anal fistulas to consider this procedure as a treatment option.
During pre-transfusion testing, lab professionals routinely encounter complex patient samples that require extended antigen typing.
The AltaValve is a Transcatheter Mitral Valve Replacement (TMVR) device designed to broaden the treatable patient population: the device's supra-annular fit and atrial-only fixation bypass the concerns of anchoring and fixation difficulties present in current TMVR technologies.
Ribometrix is a biotechnology company that develops small molecule therapeutics that directly target RNA to treat human diseases, today announced $7.8 million in additional...
The collaboration is focused on using [F-18]MK-6240 as a biomarker in Takeda’s neurodegenerative disease research. The companies will evaluate Takeda’s investigational therapeutics for potential treatment of neurodegenerative diseases in humans.
The new funding will also support product development as the company seeks to expand its portfolio of reduced thrombosis intravenous devices.
The two new techniques will initially focus on Intramedullary (IM) post-reaming and tibial condyle harvesting methodology.
The innovative portfolio, which includes 3D printed titanium interbody implants for spinal fusion surgery is designed to mimic natural bone and help facilitate spinal fusion.
Fully resorbable scaffolds manufactured from Tepha's P4HB polymer were first introduced in 2012 and have now been safely used in more than 200,000 surgical procedures around the world in both complex abdominal wall reconstruction as well as plastic and reconstructive surgery applications.
Sigma EVA, is an advanced electronic vaporizer specifically designed to provide a better way to deliver of Desflurane. Penlon will be one of a very small number of companies to have developed and launched a Vaporizer for Desflurane.
As one of the most researched troponin diagnostic tests, doctors in the U.S. can now utilize this proven technology to help detect heart attacks faster and more accurately than contemporary troponin tests.
Company also to unveil its robotic application designed to support the future of spine care.
The NIH support will enable the company to expand the applications of its first product, Renerva Peripheral Nerve Matrix (PNM), an injectable gel derived from porcine tissue that promotes and supports repair and regeneration in injured peripheral nerves.
The LENS 4K System features a Camera Control Unit with an integrated light source, Camera Head, image management options and Tablet Application in a single solution. The latest native 4K 3CMOS Ultra High Definition technology combined with Smith+Nephew's proprietary image and light processing is intended to create impressive color reproduction, image clarity, and depth of field.
The new ECHELON CIRCULAR Powered Stapler combines two innovative Ethicon technologies, 3D Stapling Technology that evenly distributes compression and Gripping Surface Technology, which provides gentler handling to reduce compressive forces on tissues.
Demonstrates up to three year local control in recurrent retroperitoneal sarcomas when implanted during surgical resection.
ViperWire Advance with Flex Tip is the latest advancement to CSI’s coronary Diamondback 360® orbital atherectomy system. Diamondback is the only atherectomy device to treat calcific coronary artery disease by both safely reducing superficial lesions and creating fractures of deep calcium, facilitating stent delivery, expansion and wall apposition for low restenosis rates.
“Our BMJ publication shows the algorithm we created can provide standardization across centers worldwide,” said Alexandre Loupy, MD, Director of the Paris Transplant Group. “The iBox risk prediction score may help guide patient monitoring and further improve the design and the development of a valid and early surrogate endpoint for clinical trials.”
To demonstrate that treatment with the Revivent TC™ System is more effective than Guideline Directed Medical Therapy (GDMT) for the treatment of ischemic heart failure.
Finia is a fully automated, modular, functionally closed system that creates the final formulation of cell and gene therapies and divides them into user-defined doses for patients. The technology automates a process that is currently manual and labor-intensive with the added risk of error.
The Series B round, which was led by Questa Capital, will be used for fueling the commercial launch of the innovative ControlRad Trace system.

MARKET REPORTS

Global Medical Imaging Industry Quarterly Tracker Q1 2019

The medical imaging and informatics industry is evolving rapidly, and new products and solutions are launched every other day. As the reimbursement environment is...

Ampoules & Syringes Worldwide Market Forecast

The rising number of health issues owing to the unhealthy lifestyle is expected to drive the market for ampoules and syringes.

European $11.18 Bn Diabetes Care Devices Market to 2027

The Europe diabetes care devices market is expected to reach US$ 11,184.6 Mn in 2027 from US$ 6,853.3 Mn in 2018. The market is estimated to grow with a CAGR of 5.7% from 2019-2027.

ASSOCIATION NEWS

Dr. Douglas Drachman Named Next Annual Scientific Session Vice Chair of the American College of Cardiology’s Annual Scientific Session

Drachman will serve as vice-chair for ACC.21 and ACC.22 and transition to chair for ACC.23 and ACC.24.

American College of Cardiology Issues Principles for Overcoming Compensation, Opportunity Inequity

The document is the first in a new series of ACC workforce health policy documents and will serve as guidance for clinicians and administrators to advance the profession toward the goals of fairness, including minimizing and reducing disparities, and improved patient care.

Updates to the 2019 Standards of Medical Care in Diabetes

Revisions include updated treatment information for adults and youth with type 2 diabetes and new guidelines for people with diabetes who use continuous glucose monitoring.

EXECUTIVES

Armijo brings significant relevant expertise in scaling operations to support the commercialization of products used in life-saving medical interventions. The company also announced it has expanded its sales force to include five new team members with deep neurovascular experience.
McNulty will lead Miach’s commercialization and sales efforts for the Bridge-Enhanced® ACL Repair (BEAR®) Implant, an investigational device designed for anterior cruciate ligament (ACL) repair.
Dr. Tinazli will oversee all commercial operations, strategic planning, business development, sales, and strategic partnerships for the point-of-care (POC) diagnostics company.
Chuck Lauer was the publisher of Modern Healthcare and a networking expert among healthcare suppliers and providers. He was known for his mentorship to others in his profession, as well as his incisive yet supportive critiques of the ways current healthcare systems were serving patients. He passed away in 2017.
Dr. Jett joins Steven Springmeyer, M.D. as co-CMO to support all aspects of the Company’s research, development and commercialization efforts. Today’s news comes as Biodesix continues to drive adoption of the recently launched Nodify XL2™ proteomic nodule classifier.
Ms. Schwarzentraub will join the Board effective immediately, with Ms. Council joining the Board effective as of December 1, 2019.

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