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May 8, 2017


Abbott Receives CE Mark for Smartphone-Compatible Insertable Cardiac Monitor

Abbott announced CE Mark and first use of the new Confirm Rx Insertable Cardiac Monitor (ICM), a smartphone-compatible ICM that will help physicians identify difficult to detect cardiac arrhythmias, including atrial fibrillation (AF), to help guide therapy. Abbott noted that since CE Mark approval, adoption of the device has been strong and implants have occurred in 10 countries across Europe. The Confirm Rx ICM is designed to continuously monitor a patient's heart rhythm and proactively transmit information via the myMerlin mobile app, allowing physicians to follow their patients remotely and accurately diagnose arrhythmias.

 

Currently the Confirm Rx ICM is available in select countries in Europe, with full European release expected during the second quarter of 2017.

 

See more information the Confirm ICM on Meddevicetracker.

 

Abbott Announces National Reimbursement FreeStyle Libre in France

 

Abbott announced that the French Health Ministry has granted national reimbursement across France for FreeStyle Libre—Abbott's glucose monitoring technology that removes the need for routine finger sticks for people with diabetes. This reimbursement decision will mean access to the FreeStyle Libre system for hundreds of thousands of people from age four across France with both Type I and Type II diabetes who use insulin multiple times per day.

 

See more information the FreeStyle Libre on Meddevicetracker.

 

Cancer Genetics Launches Liquid::Lung-cfDNA Assay for Lung Cancer

 

Cancer Genetics announced the CLIA validation and commercial launch of its next generation sequencing (NGS) assay Liquid::Lung-cfDNA to detect lung tumor-derived cell-free DNA (cfDNA) obtained from the plasma fraction of blood. The assay enables analysis of frequently mutated single nucleotide variants and short indels in 11 genes with significant clinical relevance to non-small cell lung cancer (NSCLC). The breakthrough test has a limit of detection (LOD) as low as 0.05% or 1 mutant copy of DNA in a background of 2,000 wild-type copies of DNA.
The test will perform the test for both clinical care and for trials being performed by biotech and pharmaceutical companies.

 

See more information the Liquid::Lung-cfDNA Assay on Meddevicetracker.



May 9, 2017


Boston Scientific Receives FDA Approval for Resonate Family of High Voltage Devices

Boston Scientific announced that it has received U.S. Food and Drug Administration (FDA) approval for the Resonate family of implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) systems. The approval includes new features in the Resonate devices including SmartCRT technology with Multisite Pacing capability for multi-electrode pacing, and compatibility with the HeartLogic Heart Failure Diagnostic Service to help physicians improve heart failure (HF) management.

 

All Resonate devices are powered by the company's EnduraLife Battery Technology, which has nearly two times the usable battery capacity as certain competitive devices, a factor when considering the lifelong needs of patients receiving ICD or CRT therapy. The company has initiated a series of clinical trials to demonstrate improved response to CRT therapy with SmartCRT technology, which helps physicians optimize where, when, and how to pace the lower chambers of the heart.

 

See more information the Resonate CRT-D on Meddevicetracker.

 

New Capsule Colonoscope Introduced at Digestive Disease Week

 

Preclinical data on the Capsule Colonoscope was presented at the 2017 Digestive Disease Week in Chicago. The capsule, which measures 18mm, is attached to a tether that is thinner than a typical endoscope, and is guided through the colon by an external magnet attached to a robot arm. This is the first time that a capsule robot has been autonomously controlled in-vivo in a reliable, efficient, and safe manner. The proprioceptive robotic system can autocorrect its maneuvers quickly.

 

Active autonomous intelligent manipulation of a capsule robot is a breakthrough step toward artificially intelligent endoscopist-directed capsule colonoscopy. Studies evaluating additional control algorithms are currently underway. The company expects to begin First-in-Man trials around the end of 2018.

 

See more information on the Capsule Colonoscope on Meddevicetracker.

 

Premia Spine Receives FDA Approval to Begin IDE study of TOPS System

 

Premia Spine announced that it has secured FDA approval for its pivotal study of the new TOPS System.
The IDE study will take place in 30 institutions and enroll 330 subjects. Patients will be randomized to either the TOPS System or lumbar fusion (i.e., an interbody cage plus screws and rods).

 

The TOPS device is a dynamic spinal implant designed to replace the extracted skeletal structures and stabilize the spine without permanently locking the adjacent vertebrae. Instead, clinicians allow the vertebrae to continue moving normally with the assistance of the TOPS implant. The TOPS System allows full motion at the operative level, while prohibiting excessive twists and turns.

 

See more information on the TOPS System on Meddevicetracker.

 

May 10, 2017


Medtronic Receives FDA Approval for MR-Conditional Quadripolar CRT-Ps

 

Medtronic received U.S. Food and Drug Administration (FDA) approval for a portfolio of quadripolar cardiac resynchronization therapy-pacemakers (CRT-Ps) that improve therapy delivery for patients with heart failure. These devices also allow patients to receive MRI (magnetic resonance imaging) scans in either 1.5 or 3 Tesla (T) machines. The newly approved devices, Percepta Quad CRT-P MRI SureScan, Serena Quad CRT-P MRI SureScan and Solara Quad CRT-P MRI SureScan, are expected to be available commercially in the United States in early summer 2017.

 

All three CRT-Ps also are compatible with Attain Performa MRI SureScan Quadripolar Leads, which include short bipolar spacing to reduce the occurrence of phrenic nerve stimulatio, steroid on all electrodes, and three shapes for varying patient anatomies.

 

See more information on the Percepta Quad CRT-P on Meddevicetracker.

 

Varian’s ProBeam System Approved in Japan

 

Varian Medical Systems announced it received Shonin approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) to market the ProBeam system for proton therapy in Japan.

 

Varian's ProBeam system offers fully-integrated intensity modulated proton therapy (IMPT) to enable more efficient adaptive proton therapy. Varian's pencil beam scanning technology gives clinicians the ability to deliver the dose precisely in the tumor to minimize dose to healthy tissue.

 

See more information on the ProBeam on Meddevicetracker.

 

Cook Medical Sells Vertebroplasty Product Family to IZI Medical Products

 

Cook Medical announced the sale of its comprehensive family of vertebroplasty products to IZI Medical Products for an undisclosed sum. This sale includes the Duro-Ject, Osteo-Site, Osteo-Force and Vertefix brands in addition to other needles, injectors and cements.

 

IZI Medical is the interventional products platform of Shore Capital Partners.

 

See more information on IZI Medical Products on Meddevicetracker.

 

May 11, 2017


Boston Scientific Presents Results from Post-Market Approval Study of S-ICD System

Boston Scientific announced results from a U.S. post-market approval study of its Subcutaneous Implantable Defibrillator (S-ICD) System at the Heart Rhythm Society’s 38th Annual Scientific Sessions meeting. Results demonstrated that the therapy terminated life-threatening heart arrhythmias in 98.7% of evaluated patients and also validated low complication rates, with a complication-free rate of 96.2% at 30 days post-procedure.

 

The study was a non-randomized registry, initiated in 2012 after the system received U.S. FDA approval, and included 1,637 patients implanted with the device at 86 U.S. medical centers.

See more information on the S-ICD System on Meddevicetracker.

 

May 12, 2017


Guardant Health Raises $360 Million to Sequence 1 Million Cancer Patients

Guardant Health has raised $360 million to sequence the tumor DNA of 1 million cancer patients in the next five years. SoftBank led the round, other investors included T. Rowe Price, Associates, Temasek, Sequoia Capital, Khosla Ventures, Lightspeed Venture Partners, OrbiMed and 8VC.

 

Guardant will work toward the target of 1 million patients by increasing the commercial use of its tumor test Guardant360 and running studies at sites including M.D. Anderson. Guardant360 looks for 73 cancer genes in blood samples drawn from patients. Physicians use the results to identify the treatments and clinical trials best suited to the genetics of their patients.

 

See more information on the Guardant360 on Meddevicetracker.

 

BIOTRONIK Announces FDA Approval of MultiPole Pacing with ProMRI

 

BIOTRONIK announced FDA approval of the company’s MultiPole Pacing (MPP) technology, providing physicians with additional treatment options for heart failure patients who have been non-responsive to cardiac resynchronization therapy (CRT). MPP will be available on new BIOTRONIK CRT defibrillator (CRT-D) systems for patients with heart failure.

 

BIOTRONIK CRT-D systems include MPP and feature ProMRI technology, providing patients with access to critical diagnostic imaging scans as needed. These devices are also equipped with MRI AutoDetect, a dedicated sensor that detects the MRI environment, converts the patient’s device to MRI mode, and then automatically returns to its permanent program when the scan is complete

 

See more information on the BIOTRONIK on Meddevicetracker.

 

Integra LifeSciences Launches SurgiMend for Hernia Repair

 

Integra LifeSciences announced the launch of SurgiMend MP, its latest offering in tissue-building solutions for complex abdominal hernia repair. SurgiMend MP is a 2mm thick acellular collagen matrix featuring a macroporous design that facilitates fluid drainage. The product offers physicians a biologic, yet cost-effective alternative to resorbable synthetic mesh to support healing, tissue building, and prolonged reinforcement in abdominal hernia repair.

 

SurgiMend MP is specifically indicated for plastic and reconstructive surgery, muscle flap reinforcement, and hernia repair, including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias. SurgiMend MP will be available in numerous sizes ranging from 10cm x 15cm up to 25cm x 40cm to meet the varying needs of surgeons and their patients.

 

See more information on SurgiMend on Meddevicetracker.

 

 

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