10 Promising New MedTech Devices for 201718 August, 2017
Today’s medical technology (medtech) companies face more challenges than they did in the past, and the number of medtech companies has declined. Barriers to entry include the challenges of establishing a global focus, increased regulatory hurdles and navigating reimbursement issues. Despite these challenges, many companies are bringing truly novel and innovative medical technologies to market. Below are 10 medtech organizations to look out for.
#1 Basil Leaf Technologies’ DxtER
If you’re a Star Trek fan, you’ll love this: Imagine a portable, wireless device in the palm of your hand that monitors and diagnoses your health conditions. That’s right: A tricorder! That’s the technology envisioned by the Qualcomm Tricorder XPrize Competition. This year’s winner was DxtER (pronounced Dexter) developed by Basil Leaf Technologies. DxtER is a “tricorder” prototype that uses an artificial intelligence–based engine that learns to diagnose medical conditions by integrating learnings from clinical emergency medicine, with data analysis from actual patients. It features non-invasive sensors that collect vital signs, body chemistry and biological functions. Algorithms diagnose 34 health conditions, including diabetes, atrial fibrillation, chronic obstructive pulmonary disease, urinary tract infection, sleep apnea, leukocytosis, pertussis, stroke, tuberculosis and pneumonia.
DxtER is the result of 4 years of development efforts within the Qualcomm Tricorder XPrize group. As the winner of the prize, the Final Frontier Medical team will get support from the FDA and other regulatory bodies to develop the product and continue with R&D and testing. The initiatives of the prize committee include fast-tracking international retail distribution.
#2 The OneTouch Via from Johnson & Johnson
Given the discomfort of insulin injections, the diabetes community is always searching for better alternatives. Once such promising technology is the OneTouch Via developed by Johnson & Johnson subsidiary Calibra Medical.
The OneTouch Via is a wearable patch pump that stores up to 200 units of fast-acting insulin, which is delivered by pressing two buttons on either side of the pump. The device should make life easier for diabetics, since it makes supplemental insulin delivery painless and discrete.
The wearable also tackles the problem of diabetics who don't take needed insulin at mealtimes. Due to embarrassment or discomfort, some 57% fail to do so, which can lead to serious problems such as heart disease, eye disease and long-term kidney failure.
According to studies, most diabetics find the wearable a big improvement over pens and syringes. After 60 days, 86% of diabetics using the wearable said they were very satisfied with it. In another study, 75% of doctors said they would prescribe it, as it was a better solution than insulin pens. One hundred percent said it was an improvement over insulin syringes.
#3 Boston Scientific's Vercise Deep Brain Stimulation System
Boston Scientific’s Vercise Deep Brain Stimulation System (DBS) is being studied in a clinical trial for Parkinson’s disease, primary and secondary dystonia and essential tremor.
Current DBS systems consist of one electrode implanted in each hemisphere of the brain, with each electrode having four contacts, and a bulky pulse generator implanted in the chest. In comparison, an electrode in the Vercise system has eight contacts, with each contact having the ability to be programmed individually to suit a patient's plan of therapy.
DBS systems utilizing four contacts have limitations on the dose of electrical stimulation that can be delivered. With the new system, physicians can offer a more tailored solution, minimizing electrical current in certain areas and maximizing stimulation in other areas to obtain a greater clinical effect.
#4 Medtronic's MiniMed 670G System
Medtronic’s MiniMed 670G System is an automated, self-adjusting insulin delivery system designed to maximize the amount of time diabetics spend within their target glucose range. It has been widely referred to as the world’s first artificial pancreas. The MiniMed 670G System provides quick and easy access to a patient’s glucose and insulin information, all from a bright, color home screen on the device. Knowing at all times where glucose levels are trending and self-adjusting for high or low levels greatly reduces the need for multiple daily injections (MDIs)
The FDA approved the MiniMed 670G System in 2016 and Medtronic made it commercially available in the United States in the spring of 2017.
#5 Medtronic's Resolute Onyx Drug-Eluting Stent
A drug-eluting stent (DES) is a peripheral or coronary stent (a scaffold) placed into narrowed, diseased peripheral or coronary arteries that slowly releases a drug to block cell proliferation. This prevents fibrosis that, together with clots, could otherwise block the stented artery, a process called restenosis. The stent is usually placed within the peripheral or coronary artery by an interventional cardiologist or interventional radiologist during an angioplasty procedure.
In May of 2017, Medtronic announced FDA approval and U.S. launch of its Resolute Onyx Drug-Eluting Stent. A press release published by the company states that, “The Resolute Onyx DES builds on the proven clinical performance and superior deliverability of the Resolute Integrity™ DES to further strengthen the gold standard safety and efficacy of DES technology.”
The Resolute Onyx DES is the first and only DES to feature Core Wire Technology, an evolution of Continuous Sinusoid Technology (CST). CST is a unique Medtronic method of stent manufacturing, which involves forming a single strand of cobalt alloy wire into a sinusoidal wave to construct a stent. This enables greater deliverability and conformability to the vessel wall. With Core Wire Technology, a radiopaque inner core is incorporated within the cobalt alloy wire to enhance visibility for accurate stent placement. Core Wire Technology also enables thinner struts while maintaining structural strength.
#6 Neuronix Medical's neuroAD Therapy System
Late last year, Neuronix announced positive results from a pivotal, double-blind placebo-controlled, multicenter clinical study, for the assessment of safety and efficacy of its neuroAD Therapy System, in the treatment of mild to moderate Alzheimer’s disease. Neuronix has filed a de novo application seeking regulatory clearance from the FDA. If approved, the neuroAD Therapy System would be the first medical device ever cleared by the FDA for treatment of Alzheimer’s disease.
The neuroAD Therapy System is a patent-protected, non-invasive medical device, uniquely combining transcranial magnetic stimulation (TMS) with cognitive training, to concurrently target brain regions affected by Alzheimer’s disease. This dual-stimulation is designed to improve the cognitive performance of patients, following an intervention protocol, which lasts for six weeks, five days per week, with one hour-long session per day.
The neuroAD Therapy System would bring new hope for the millions of Alzheimer’s patients and their families, who find themselves in a race against time searching for an effective treatment to manage the debilitating effects of Alzheimers.
#7 BioLert App
People with seizure disorders live day to day, hour to hour, not knowing when the next attack will occur. This reality can dramatically lower quality of life for those coping with such disorders as well as their caretakers and loved ones.
BioLert is a software as a service (SaaS) product that monitors epileptic patients, detects epilepsy episodes and notifies caregivers or family members when an event occurs. Via the user’s personal smart watch or smartphone, the product records all tracked data (including video and audio, if available). BioLert’s actionable seizure alert system monitors and detects vital information, automatically notifying caregivers when neurological events occur so that help, if needed, can arrive. What’s more, the BioLert system automatically saves all tracked vital signs and event data in the cloud. Cloud-based data gives healthcare providers and medical research teams easy, permission-based access to patient information, with the goal of developing better treatments for the individual as well as the community at large.
#8 St. Jude Medical's HeartMate 3 Left Ventricular Assist System
St. Jude’s HeartMate 3 Left Ventricular Assist System (LVAS) is indicated for destination therapy, bridge-to-transplantation and myocardial recovery.
According to St. Jude’s website, “The HeartMate 3™ LVAS is designed to provide mechanical circulatory support to a broad range of advanced heart failure patients. Building on proven results from the CentriMag™ Pumps, the HeartMate 3 LVAS employs Full MagLev™ flow technology designed to optimize hemocompatibility and reduce blood trauma through gentle blood handling.”
During a clinical trial, HeartMate 3 LVAS patients showed a 98-percent survival rate at 30 days and 92 percent at 6 months. Most saw significant improvements in symptom reduction and quality of life.
The device is currently commercially available for use in select international markets where it offers physicians the most advanced ventricular assist technology available to support management of patients with advanced heart failure.
#9 Stryker's Triathlon Total Knee on the MAKO System
Over the years, knee replacement techniques and instrumentation have undergone countless improvements. Stryker’s Mako Robotic-Arm Assisted Technology with Triathlon Total Knee implants is an example of how technology is transforming the way joint replacement surgeries are being performed.
Don’t worry though; your orthopedic surgeon is not out of a job. Stryker’s website states, “When you hear ‘robotic-arm assisted technology,’ it’s important to understand that the Mako Robotic-Arm doesn’t actually perform the surgery. Surgery is performed by an orthopedic surgeon, who uses the Mako System software to pre-plan your surgery. Your orthopedic surgeon will guide the Mako robotic-arm to remove diseased bone and cartilage. Then the surgeon will insert a Triathlon Total Knee implant.”
Mako Technology was designed to help surgeons provide patients with a personalized surgical experience based on their specific diagnosis and anatomy.
#10 TransEnterix's Senhance Surgical Robotic System
TransEnterix is a medical device company that is pioneering the use of robotics to improve minimally invasive surgery by addressing the clinical and economic challenges associated with current laparoscopic and robotic options. The company is focused on the commercialization of the Senhance Surgical Robotic System, a multi-port robotic system that brings the advantages of robotic surgery to patients while enabling surgeons with innovative technology such as haptic feedback and eye sensing camera control. The company is also developing the SurgiBot™ System, a single-port, robotically enhanced laparoscopic surgical platform. The Senhance Surgical Robotic System has been granted a CE Mark but is not currently available for sale in the United States.
According to a BusinessWire press release, TransEnterix announced in February of this year that the company has successfully begun clinical use of the Senhance Robotic Surgical System in France as part of its Clinical Leadership Program.
Professor Celine Chauleur, a gynecologic oncologist at CHU Saint-Ètienne, was the first surgeon to utilize the Senhance system in France. The first case — a hysterectomy for endometrial cancer with pelvic lymphadenectomy — was performed on February 7, 2017. The surgery was successfully performed and the patient was discharged less than 24 hours after procedure.
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