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June 12, 2017
Insulet Presents Pediatric Artificial Pancreas Data at ADA
Insulet Corporation announced new data on the OmniPod Horizon System that demonstrated pediatric and adolescent populations experienced positive results consistent with the performance in the adult population of OmniPod Horizon users. The 36-hour study included a modified version of Insulet's Omnipod System, a Dexcom continuous glucose sensor, and Insulet's personalized MPC algorithm with announced meals ranging from 30-90 grams of carbohydrates and limited physical activity. Overall, the study included 34 adults, 12 adolescents and 12 pediatric patients with type 1 diabetes.
Key findings in the pediatric and adolescent patients included greater than 70% of time spent in the target blood glucose range overall and approximately 85% or greater time in the target range overnight. These initial results indicate that the algorithm performance can address the unique challenges faced by pediatric populations with high insulin sensitivity and adolescents who tend to be insulin resistant.
See more information the OmniPod Horizon System on Meddevicetracker.
Tandem Diabetes Announces First Results from Predictive Low Glucose Suspend (PLGS) Algorithm at ADA
Tandem Diabetes Care presented results from a feasibility study for its predictive low glucose suspend (PLGS) algorithm used with the t:slim Insulin Pump, designed to suspend insulin delivery when low blood sugar is predicted.
The system performed as expected during the study, successfully suspending insulin delivery when continuous glucose monitoring (CGM) values were predicted to be below 80 mg/dL in the next 30 minutes, and subsequently resuming insulin when CGM values began to rise. No hypoglycemic events were observed during the study, and peak CGM values two hours after suspension averaged 91 mg/dl, reflecting normal glycemic control without rebound hyperglycemia.
See more information the t:slim Insulin Delivery System on Meddevicetracker.
Qualcomm and Johnson & Johnson Announce Blood Glucose Meter Agreement
Qualcomm, through its subsidiary Qualcomm Life, announced its agreement with LifeScan, one of the Johnson & Johnson Diabetes Care Companies (JJDCC), to streamline wireless data capture from LifeScan’s OneTouch Verio Flex blood glucose meters to physicians to enable more informed care. Qualcomm Life’s medical-grade 2net solution will power the connectivity for efficient, cable-free data collection.
By using Qualcomm Life’s medical-grade 2net solution, physicians will be able to conveniently access all of the patients’ blood glucose data from Lifescan’s OneTouch Verio Flex blood glucose monitoring system with built-in Bluetooth Smart Technology, which wirelessly sends data to the OneTouch Reveal cloud-based application.
The companies plan to deploy the 2net solution to select physician offices in the Fall of 2017, and expand globally in 2018.
See more information the OneTouch Verio Flex on Meddevicetracker.
June 13, 2017
SI-Bone Receives FDA Clearance and Announces Launch of iFuse-3D Implant
SI-BONE announced FDA 510(k) Clearance and full U.S. Commercial Launch of the iFuse-3D Implant, the first ever 3D-printed titanium implant for use in the sacroiliac joint (SI) joint.
The iFuse-3D Implant combines the patented triangular shape of the iFuse Implant with a proprietary 3D-printed porous trabecular surface and patented fenestrated design to promote bone ongrowth, ingrowth, through growth and intra-articular fusion
See more information the iFuse Implant on Meddevicetracker.
OvaScience Completes Enrollment in OvaPrime Clinical Study
OvaScience announced it has completed enrollment of 70 patients in its ongoing clinical study of the OvaPrime treatment, designed to assess the safety of OvaPrime in women with either primary ovarian insufficiency (POI) or poor ovarian response (POR). OvaPrime is a potential fertility treatment that could enable a woman who makes too few or no eggs to increase her egg reserve by using her own egg precursor cells.
An initial data readout from 20 patients, including safety data from six months post-EggPC cell reintroduction, is expected by year-end 2017. The Company expects to complete biopsies in 70 patients by the end of 2017 and reintroductions in 70 patients by the end of the first half of 2018.
See more information on the OvaPrime on Meddevicetracker.
June 14, 2017
U.S. FDA Approves Humalog Junior KwikPen for Diabetes
The U.S. Food and Drug Administration (FDA) approved Eli Lilly’s Humalog Junior KwikPen for the treatment of diabetes. Humalog Junior KwikPen is a prefilled pen with half-unit dosing capability, enabling finer dose adjustment for those who need it.
Humalog Junior KwikPen will be available in U.S. pharmacies later this year. Lilly also has a pending application for Humalog Junior KwikPen regulatory approval in the European Union.
See more information on the Humalog Kiwk Pen on Meddevicetracker.
June 15, 2017
electroCore Receives 510(K) Clearance for gammaCore-D for Cluster Headaches
electroCore announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to market a newer version of gammaCore (non-invasive vagus nerve stimulator) – the gammaCore-S – for the acute treatment of pain associated with episodic cluster headache (eCH) in adult patients. gammaCore transmits a mild electrical stimulation to the vagus nerve through the skin to block the pain signals that cause eCH.
gammaCore-S has been available in countries outside of the U.S., including the European Union, since 2015 and will be commercially available in the U.S. early in the third quarter of 2017.
See more information on the gammaCore on Meddevicetracker.
Published Data Confirms Potential of MiMedx dHACM Allografts for Regenerative Applications in Orthopedics
MiMedx Group announced that the latest peer-reviewed scientific and clinical review article of the MiMedx dehydrated human amnion/chorion membrane ("dHACM") EpiFix allografts has been electronically published in the journal Techniques In Orthopaedics.
The paper entitled "Dehydrated Human Amnion/Chorion Membrane Allografts as a Therapy for Orthopedic Tissue Repair" discusses the basic structure, function, and components of dHACM and its current in vitro, in vivo, and clinical usages in orthopedic tissue repair applications, summarized as follows: The delivery of growth factors, cytokines, and protease inhibitors by dHACM allografts modulates the three main phases of healing including inflammation, proliferation, and remodeling; Current research and clinical cases for repairing orthopedic tissues have shown that dHACM allografts have promising results in repairing injured and diseased tissues due to their ability to reduce scar tissue formation, modulate inflammation, and enhance healing;
dHACM allografts have been evaluated for repair of tendon and ligament, attenuation of cartilage and joint space diseases, and prevention of scarring and adhesion formation in spinal fusion procedures.
See more information on the EpiFix on Meddevicetracker.
Parexel and Sanofi Explore Use of Wearables in Clinical Trial
PAREXEL announced a collaboration with Sanofi to advance the use of wearable devices to transform the collection of data in clinical trials. The companies are examining how data collected from several wearable devices can be streamlined into a single, scalable data system to provide valuable insights.
Currently, PAREXEL and Sanofi are collaborating on a pilot study using PAREXEL’s recently launched patient sensor solution to demonstrate the scientific and medical viability of wearables. In an ongoing single-site study, patient data is being collected remotely and simultaneously via multiple wearable devices. Publication of final study results is expected in the near future.
See more information on Sanofi on Meddevicetracker.
June 16, 2017
Endologix Announces Enrollment of First Patient in ELEVATE IDE Study
BTG announced it presented results of the ACCESS PTS trial, at the Society for Vascular Medicine's 28th Annual Scientific Sessions in New Orleans. The study found chronic deep vein thrombosis (DVT) patients with post-thrombotic syndrome (PTS) can be treated safely and effectively with EKOS Therapy.
The ACCESS PTS study is a multicenter prospective single-arm study of 73 patients with iliofemoral DVT, meeting eligibility including a Villalta Score of 8 or greater (Villalta Score measures the signs and symptoms of PTS), and who had failed three months of conservative therapy. The study met its primary efficacy endpoint and showed a significant improvement of Villalta Scores of 34% at 30 days across 77 limbs treated among the 73 patients with a p-value of <0.0001.
See more information on the EkoSonic Endovascular System on Meddevicetracker.
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