Royal Philips will get Food and drug administration 510(k) clearance for small parts ultrasound imaging solution

MDBR Staff Author Printed 16 October 2017

Health technology firm Royal Philips has guaranteed 510(k) clearance in the US Fda (Food and drug administration) because of its new small parts ultrasound imaging solution.

Philips EPIQ Ultimate Small Parts Solution continues to be approved to identify abnormalities within the small organs, that are near to the skin.

On Philips EPIQ 7 and 5 and Affiniti 70 ultrasound systems, the brand new solution is going to be showcased in the 16th World Federation for Ultrasound in Medicine and Biology (WFUMB) Congress in Taipei.

Philips EPIQ Ultimate Small Parts Solution includes four additional features, containing eL18-4 PureWave straight line array transducer, Philips microFlow imaging, Philips elastography and Philips precision biopsy.

Philips eL18-4 transducer helps you to deliver detail resolution and tissue uniformity for clinical solutions, containing thyroid, breast, testicular, musculoskeletal, vascular, bowel, pediatrics and obstetrics.

The brand new eL18-4 transducer may also help to judge musculoskeletal injuries.

The MicroFlow Imaging offers better sensitivity and detail for small vessel bloodstream flow assessment, while complete Elastography solution with strain and ElastQ Imaging capability offers definitive info on tissue stiffness.

Philip new precision biopsy abilities let it minimize needle blind zones and support the opportunity to boost the display of needle glare.

Philips ultrasound business leader Vitor Rocha stated: “The superb picture quality produced from Philips’ breakthrough, ultra-broadband frequency transducer together with full solution Elastography support, helps clinicians make confident clinical decisions driven by a test that’s simpler to do.

“With the brand new Philips Ultimate Small Parts Solution, clinicians are in possession of the ability to comprehensively assess and treat small parts and deliver better take care of their sufferers with all of-in-one functionality.”  


Image: The brand new Philips eL18-4 PureWave straight line array transducer will provide detail resolution and tissue uniformity for clinical solutions. Photo: thanks to Koninklijke Philips N.V.

Quidel will get Food and drug administration nod for Solana RSV + hMPV assay

MDBR Staff Author Printed 18 October 2017

Diagnostic testing solutions provider Quidel has guaranteed approval in the US Fda (Food and drug administration) because of its Solana respiratory system syncytial virus (RSV) + human metapneumovirus (hMPV) assay.

Solana RSV + hMPV assay will be employed to identify nucleic acids isolated from nasal and nasopharyngeal swabs from patients with signs and signs and symptoms of respiratory system infection.

Solana, which leverages the firm’s helicase-dependent amplification (HDA) technology, can process as much as 12 patient samples in every 45-minute run.

In August, the organization guaranteed CE mark approval for Solana RSV + hMPV assay.

Based on the organization, the Solana RSV + hMPV assay is meant to be used just with the Solana instrument.

Quidel president and Chief executive officer Douglas Bryant stated: “We are content introducing yet another innovative, rapid testing solution that addresses the key reason for viral respiratory system infections both in the youthful and seniors, RSV and hMPV.

“This economic and focused method of testing to identify and differentiate these infections replaces costly syndromic panels or laboratories able to performing high complexity testing.”

In This summer, Quidel decided to acquire Alere’s Triage and BNP companies for approximately $440m.

Underneath the deal, Quidel will acquire Triage MeterPro cardiovascular (CV) and toxicology assets (Triage business) and also the B-type Naturietic Peptide (BNP) assay business operate on Beckman Coulter analyzers (BNP business) from Alere.

The merchandise line is being divested to secure antitrust approvals required for Abbott’s pending purchase of Alere.


Image: The Food and drug administration campus in Nh Ave, Silver Spring, Maryland. Photo: thanks to The U.S. FdaOrWikipedia.

Food and drug administration approves expanded indication for NuVasive’s TLX interbody system

MDBR Staff Author Printed 17 October 2017

The United States Fda (Food and drug administration) has approved an expanded indication for NuVasive’s TLX interbody system to make use of in spine fusion surgery.

The clearance is stated introducing an expanding 20 degree cage and broader indications to be used, including use with allogeneic bone graft and extra quantity of a spine.

NuVasive’s TLX interbody product is a sophisticated solution, which may be placed via a conventional transforaminal lumbar interbody fusion (TLIF) approach.

The organization is promoting a non-invasive method for the TLIF procedure known as Maximum Access Surgery (MAS) TLIF.

Developed for use having a non-invasive spine surgery approach, TLX implants can be put seamlessly in to the disc space because of their low profile and bulleted design.

Made to induce lordosis within an physiological way, the TLX interbody system offers restoration of sagittal alignment with customizable levels of lordosis.

TLX interbodies were obtainable in 15 degree lordotic options prior to the expanded 510(k) clearance, that are only indicated to be used with allograft.

The currenr clearance enables to make use of the machine with 20 degree expanding interbody, additionally to allogeneic bone graft made up of cancellous or corticocancellous bone graft to facilitate fusion.

NuVasive’s TLX interbody system, together with Integrated Global Alignment (iGA) software suite enables surgeons to calculate, correct and ensure a patient’s pathology.

 NuVasive strategy, technology and company development executive v . p . Matt Link stated: “With the extra clearance for the latest TLX system, we currently supply the leading tools for TLIF procedures with this MAS TLIF solution, validating our dedication to improving spine solutions.

“This clearance highlights our persistant purchase of transforming spine outcomes by developing spine’s leading procedures, materials, expandables, systems and services.”


Image: The Food and drug administration campus in Nh Ave, Silver Spring, Maryland. Photo: thanks to The U.S. Fda.

Food and drug administration clears new robotically-aided surgical device for adult patients

SILVER SPRING, Md., March. 13, 2017 /PRNewswire-USNewswire/ — Today, the U.S. Fda removed the Senhance System, a brand new robotically-aided surgical device (RASD) that will help facilitate non-invasive surgery.

“Non-invasive surgery helps in reducing discomfort, scarring and time to recover after surgery,” stated Binita Ashar, M.D., director from the Division of Surgical Devices within the FDA’s Center for Devices and Radiological Health. “RASD technologies are a specialized innovation in non-invasive surgery made to boost the surgeon’s access and visualization within limited operative sites.” 

RASD, sometimes known as automatic surgery, is one sort of computer-aided surgical system. RASD enables choices to make use of computer and software technology to manage and move surgical instruments through a number of small incisions within the patient’s body (laparoscopic surgery) in a number of surgical treatment or operations. The advantages of RASD technology can include being able to facilitate non-invasive surgery and help with complex tasks in limited parts of the body. The unit isn’t really a robotic since it cannot perform surgery without direct human control.

The style of the Senhance System enables surgeons to sit down in a console unit or cockpit that gives a 3-D high-definition look at the surgical field and enables these to control three separate automatic arms remotely. The finish of every arm is outfitted with surgical instruments that derive from traditional laparoscopic instrument designs. The machine includes unique technological characteristics: pressure feedback, which will help choices “feel” the stiffness of tissue being understood through the automatic arm eye-tracking, which will help control movement from the surgical tools and laparoscopic-type controls much like traditional surgical equipment.

The Senhance System is supposed to help in the accurate charge of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization and retraction in laparoscopic colorectal surgery and laparoscopic gynecological surgery. The machine is perfect for experience adult patients by trained physicians within an operating room atmosphere.

The maker conducted a clinical study of 150 patients undergoing various gynecological operations using the Senhance System. Clinical outcomes were when compared with individuals described in eight peer-reviewed research publications involving greater than 8,000 gynecological operations performed in tangible-world settings (real-world evidence) using another RASD. Additionally, the maker posted Senhance System operative results involving 45 patients undergoing colorectal measures in a genuine-world setting and compared the outcomes to individuals from peer-reviewed research publications describing the actual-world device experience. The Food and drug administration figured that these study data, based on real-world evidence, together with performance testing under simulated use and worst-situation scenario conditions, shown the substantial equivalence from the Senhance System towards the da Vinci Si IS3000 device for gynecological and colorectal procedures.

The Senhance System was reviewed with the premarket clearance (510(k)) path. A 510(k) notification is really a premarket submission produced by device manufacturers towards the Food and drug administration to show the new system is substantially equal to a legally marketed predicate device.

The Food and drug administration granted clearance from the Senhance System to TransEnterix Surgical Corporation.

The Food and drug administration, a company inside the U.S. Department of Health insurance and Human Services, protects the general public health by assuring the security, effectiveness, and security of human and veterinary drugs, vaccines along with other biological products for human use, and medical devices. The company also accounts for the security and safety in our nation’s food, cosmetics, nutritional supplements, items that produce electronic radiation, as well as for controlling cigarettes and tobacco products.

More details:
Food and drug administration: Lately Approved Devices
Food and drug administration: Premarket Clearance (510(k))
Food and drug administration: Computer Aided Surgical Systems

Media Queries: Stephanie Caccomo, 301-348-1956, [email protected] and drug administration.hhs.gov
Consumer Queries:
888-INFO-Food and drug administration

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SOURCE U.S. Fda

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Food and drug administration clears first 7T magnetic resonance imaging device

Printed 13 October 2017

The United States Fda removed the very first seven tesla (7T) magnetic resonance imaging (MRI) device, greater than doubling the static magnetic field strength readily available for use in america.

The Magnetom Terra may be the first 7T MRI system removed for clinical use in america.

“The general picture quality of MRI improves with greater magnetic field strength,” mentioned Robert Ochs, Ph.D., director from the Division of Radiological Health within the FDA’s Center for Devices and Radiological Health. “The additional field strength enables for much better visualization of smaller sized structures and subtle pathologies that could improve disease diagnosis.”

MRI is really a medical imaging method that creates pictures of the interior structures from the body. MRI scanners use strong magnetic fields and radio waves (radiofrequency energy) to create images. The signal comes mainly in the protons in fat and water molecules in your body.

When construed with a trained physician, images from your MRI scan provide information which may be helpful in figuring out an analysis. MRI scanners are available in different magnet field strengths measured in tesla or “T.” Before today’s clearance, clinical MRI systems were obtainable in field strengths of 3T and below.  

The Food and drug administration reviewed the Magnetom Terra with the 510(k) premarket clearance path. A 510(k) is really a premarket submission designed to the Food and drug administration to show that the new system is substantially equal to a legally marketed predicate device.

The Food and drug administration based its clearance on comparison to some predicate tool and purchase of sample clinical images. The company reviewed the security from the radiofrequency subsystem through computational modeling, simulations and rigorous experimental validation.

The maker also provided data from the comparative study of 35 healthy patients that compared images of the sufferers while using 7T tool and images while using 3T device. Board-certified radiologists reviewed the pictures and confirmed the images acquired around the 7T device were of diagnostic quality and, in some instances, a noticable difference over imaging in the 3T.

The Magnetom Terra is perfect for patients who weigh greater than 66 pounds, and it is restricted to examinations from the mind, legs and arms (extremities).

The Food and drug administration granted clearance of Magnetom Terra system to Siemens Medical Solutions.

Source: Company Pr Release

Food and drug administration Committee recommends gene therapy for retinal disease to assist prevent blindness

Within an encouraging sign for Spark Therapeutics, a U.S. Fda Committee voted unanimously to recommend approval of their new biologics application for Luxturna a gene therapy to deal with patients with vision loss because of a hereditary retinal disease, based on a business news release. Such favorable committee votes frequently bode well for Food and drug administration approval.

The Food and drug administration Cellular, Tissue and Gene Therapies Advisory Committee voted unanimously to recommend the therapy.

There is currently no known strategy to RPE65-mediated inherited retinal disease, which often results in complete blindness, based on principal Investigator Dr. Albert Maguire, who is another professor of ophthalmology at the Scheie Eye Institute at the College of Pennsylvania’s Perelman Med school. He is another physician in the Division of Pediatric Ophthalmology at Children’s Hospital of Philadelphia.

A Phase 3 trial of Luxturna was conducted from 2013 to 2015. The medical trial had 41 participants aged four to 44 years of age with vision loss spanning from mild to advanced. Confirmed biallelic RPE65 mutations and the existence of sufficient viable retinal cells were established in most participants, based on the release.

Still, the positive news was tempered with the matter that the potency of the therapy vary with respect to the quantity of viable retinal cells patients have remaining once they get the treatment, Endpoints noted citing Food and drug administration documents.

Other critical questions remain, namely the cost this gene therapy would command and just how Spark Therapeutics would charge for this.

The gene therapy developer is a spin from Children’s Hospital of Philadelphia.

The Food and drug administration set to start dating ? of The month of january 12 the coming year to examine whether or not to grant approval for Luxturna.

Other products in Spark’s pipeline include gene therapy programs to deal with neurodegenerative illnesses, hematologic disorders along with other types of inherited blindness.

Photo: Getty Images

Respicardia’s remede system receives Food and drug administration approval

Printed 11 October 2017

Respicardia has gotten approval in the US Fda (Food and drug administration) approval because of its remedē system, a transvenous implantable neurostimulation system that energizes the phrenic nerve, and engages the diaphragm to revive natural breathing while asleep in patients with central anti snoring (CSA).

The regulatory approval took it’s origin from findings in the remede System pivotal trial, which shown that transvenous neurostimulation using the remede System can considerably reduce the seriousness of CSA, improve sleep, quality of existence and patient satisfaction. The information in the pivotal trial were printed within the Lancet in September 2016.

The remede Product is indicated to treat moderate to severe CSA in adult patients. CSA is really a serious breathing disorder that disrupts the standard respiratory rate while asleep and negatively affects quality of existence and overall cardiovascular health.

CSA is a result of the brain’s lack of ability to transmit appropriate signals towards the respiratory system muscles to stimulate breathing. 

“We’re thrilled the remede System received Food and drug administration approval and therefore are excited to supply this effective and safe therapy that’s shown to improve the caliber of existence for CSA patients,” stated Bonnie Labosky, President and Chief executive officer of Respicardia.

 “This can be a significant advance within our efforts to provide clinicians a breakthrough and efficient treatment choice for their sufferers with CSA.”

Current treatments are restricted and there’s a sizable unmet need. The remede System’s novel method of treating CSA is really a physiologic treatment that produces negative pressure to maneuver air in to the lung area, much like normal breathing. The machine initiates therapy instantly and continues at night time without resorting to someone to use any exterior equipment. 

“The patients at our center given the remede System experienced outstanding results and significant decrease in their CSA signs and symptoms,” stated Maria Rosa Costanzo, MD, Principal Investigator from the remede System Pivotal Trial. “Getting a therapeutic choice for patients with CSA that instantly provides therapy and works at night time is really a breakthrough strategy to this serious breathing disorder.”

Within the remede System pivotal trial, 96% of patients were highly pleased with their therapy. The organization intentions of a preliminary limited release which will progress to broader market commercialization.

The remede System Pivotal Trial, a potential, multicenter, randomized controlled trial, evaluated the security and effectiveness of transvenous phrenic nerve stimulation while using remede System in patients with moderate to severe CSA.

The main effectiveness effects were an evaluation from the proportion of patients within the treatment versus control groups achieving a decrease in apnea-hypopnea index (AHI) of fifty percent or greater from baseline to six several weeks. Clinical investigators at 31 sites in the U . s . States and Europe implanted the remede System in 151 patients and randomized them 1:1 towards the treatment or control group.

The trial met its primary endpoint for effectiveness. Within the modified intention-to-treat population, considerably more patients within the treatment group achieved 50 % or greater decrease in AHI from baseline to six several weeks than individuals within the control group having a clinically significant difference of 41% (p<0.0001).

Furthermore, the 12-month freedom from serious adverse occasions associated with the implant procedure, remede System or delivered therapy was 91 percent.

Source: Company Pr Release

Food and drug administration approves LivaNova’s next-generation VNS therapy to deal with epilepsy

MDBR Staff Author Printed 10 October 2017

United kingdom-based LivaNova has guaranteed approval in the US Fda (Food and drug administration) because of its next-generation Vagus nerve stimulation (VNS) therapy to treat epilepsy.

The most recent VNS system features SenTiva implantable generator and subsequently-generation VNS therapy programming system to deal with patients with drug-resistant epilepsy.

LivaNova’s VNS therapy programming system includes wireless wand and new interface on the small tablet.

SenTiva is alleged is the epilepsy device of their size to incorporate identify and respond mode to prevent seizures before they begin and instantly deliver extra therapy to prevent them when they occur.

The unit also collects and logs occasions generally connected with seizures for example patient’s body position and heartbeat variations.

The VNS therapy programming system works with all LivaNova VNS therapy generators, additionally to SenTiva.

LivaNova The United States president and neuromodulation business franchise gm Jason Richey stated: “We produced SenTiva and also the associated VNS Therapy Programming System according to feedback caused by patients and physicians to make sure simplicity of use, better patient care and price effectiveness.

“Additionally, SenTiva’s lightweight enables for any much more comfortable experience for pediatric patients, that is advantageous since VNS Treatments are the foremost and only system that’s Food and drug administration approved for drug-resistant epilepsy in youngsters as youthful as four years old.Inches

Located in London, LivaNova operates three sections, including cardiac surgery, neuromodulation and cardiac rhythm management.


Image: SenTiva may be the tiniest and lightest responsive therapy for drug-resistant epilepsy. Photo: thanks to Business Wire.

Breakfast Technical Briefing on Medical Equipment Stocks — Abbott Laboratories, Boston Scientific, Edwards Lifesciences, and Medtronic

NEW You are able to, October 10, 2017 /PRNewswire/ —

If you prefer a Stock Review on ABT, BSX, EW, or MDT then stop by to http://dailystocktracker.com/register/ and join your free customized report. Medical Appliances and Equipment companies participate in the output of medical instruments for example dental and surgical appliances. More often than not, these businesses are structured as corporations. Pre-market today, DailyStockTracker.com monitors Abbott Laboratories (New york stock exchange: ABT), Boston Scientific Corp. (New york stock exchange: BSX), Edwards Lifesciences Corp. (New york stock exchange: EW), and Medtronic PLC (New york stock exchange: MDT). Daily Stock Tracker printed free research reports on these stocks today at:

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Abbott Laboratories
 

North Chicago, Illinois headquartered Abbott Laboratories’ shares declined .62%, closing Monday’s buying and selling session at $54.66. The stock recorded a buying and selling amount of 3.99 million shares. The Business’s shares have advanced 5.07% within the last month, 13.52% within the previous three several weeks, and 42.31% since the beginning of this season. The stock is buying and selling 7.35% above its 50-day moving average and 18.40% above its 200-day moving average. Furthermore, shares of Abbott Labs, which manufactures and sells healthcare products worldwide, possess a Relative Strength Index (RSI) of 69.62.  

On September 20th, 2017, Abbott Labs announced that it’ll report its Q3 2017 financial results on October 18th, 2017, prior to the market opens. The announcement is going to be adopted with a business call at 9:00 a.m. ET. The live webcast from the call is going to be accessible around the Company’s Investor Relations website.

On October 06th, 2017, research firm JP Morgan started again its ‘Neutral’ rating around the Company’s stock. See our free and comprehensive research set of ABT at:

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Boston Scientific 

On Monday, shares in Marlborough, Massachusetts headquartered Boston Scientific Corp. recorded a buying and selling amount of 4.34 million shares. The stock declined .58%, ending your day at $29.33. The Business’s shares have advanced 1.88% previously month, 6.54% in the last three several weeks, and 35.60% with an YTD basis. The stock is buying and selling above its 50-day and 200-day moving averages by 5.53% and 12.42%, correspondingly. In addition, shares of Boston Scientific, which develops, manufactures, and markets medical devices to be used in a variety of interventional medical specialties worldwide, come with an RSI of 64.11.  

On October 04th, 2017, Boston Scientific (BSX) announced the appointment of Desiree Ralls-Morrison as senior v . p ., general counsel, and company secretary. Ralls-Morrison will join BSX on November 30th, 2017 as part of the manager committee, with responsibility for supplying a lawyer over the Company’s global companies and processes, and overseeing its global compliance function. BSX free research report is simply a look away at:

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Edwards Lifesciences 

Irvine, California headquartered Edwards Lifesciences Corp.’s stock finished your day 1.11% lower at $110.22 having a total buying and selling amount of 854,414 shares. The Business’s shares have advanced 17.63% with an YTD basis. The stock is buying and selling above its 200-day moving average by 4.32%. Furthermore, shares of Edwards Lifesciences, which supplies products and technologies to deal with structural cardiovascular disease and critically ill patients worldwide, come with an RSI of 45.70. Join your complimentary set of EW at:

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Medtronic 

Shares in Dublin, Ireland headquartered Medtronic PLC ended yesterday’s session 3.61% lower at $76.93. The stock recorded a buying and selling amount of 12.76 million shares, that was above its three several weeks average amount of 4.78 million shares. The Business’s shares have advanced 8.00% since the beginning of this season. The stock is buying and selling 5.33% below its 50-day moving average. Furthermore, shares of Medtronic, which manufactures and sells device-based medical therapies to hospitals, physicians, clinicians, and patients worldwide, come with an RSI of 33.78.  

On September 12th, 2017, Medtronic announced the worldwide launch from the StealthStation[TM] Ing, a brand new surgical navigation system created for surgeons treating conditions inside the ear, nose, and throat anatomy. The Organization has gotten US Fda 510k clearance and CE (Conformité Européenne) Mark for that system.

On October 09th, 2017, research firm Stifel reiterated its ‘Hold’ rating around the Company’s stock having a loss of the prospective cost from $91 a share to $83 a share. Sign up for free on DailyStockTracker.com and download the most recent research set of MDT at:

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Endologix receives IDE approval for EVAS2 confirmatory study to evaluate Nellix endovascular aneurysm sealing system

Printed 09 October 2017

Endologix has gotten investigational device exemption (IDE) approval in the US Fda (Food and drug administration) to commence a confirmatory clinical study to judge the security and effectiveness from the Nellix endovascular aneurysm sealing system (EVAS) for that endovascular management of infrarenal abdominal aortic aneurysms.

The EVAS2 IDE Multicenter Safety and Effectiveness Confirmatory Study (“EVAS2”) will prospectively assess the refined Indications to be used (IFU) and also the Nellix Gen2 EVAS System.

The research qualifies to sign up as much as 90 primary patients, with one-year follow-up data needed for that Pre-market Approval Application (PMA).

The Nellix EVAS product is an endovascular abdominal aortic aneurysm (“AAA”) therapy made to seal the whole aneurysm. Nellix is the foremost and only EVAS product developed as a substitute treatment method of traditional EVAR devices.

John McDermott, Ceo for Endologix, stated, “We’re very happy to receive IDE approval from the FDA to begin this confirmatory study and expect to collaborating using the investigators to offer the objective of commencing enrollment through the finish of the year.

In line with the anticipated enrollment timeline, one-year follow-up period, and regulatory review process, we still estimate PMA approval in 2020.”

Endologix, Corporation. develops and manufactures non-invasive treating aortic disorders. The Business’s focus is endovascular stent grafts to treat abdominal aortic aneurysms (AAA). AAA is a weakening from the wall from the aorta, the biggest artery in your body, producing a balloon-like enlargement. Once AAA develops, it is constantly on the enlarge and, if not treated, becomes more and more prone to rupture.

Source: Company Pr Release