• Institute of Good Manufacturing Practices India

Trusted by organizations & training participants in over 30 countries
Training | Certification | Education | Research


Medical Coding Newsletter

  • 13 May 2019

    3D Printed Medical Device: Health Canada issued new guidance
    “Technical considerations for non-clinical assessment of medical devices containing nitinol,” is the new draft guidance published by the FDA recently. The proposed recommendation which must be included by the manufacturers during premarket submission of nitinol containing devices is included in this draft guidance. Recommended tests to assess nitinol devices such as biocompatibility, performance under temperature and stresses, and susceptibility to corrosion are also included in the guidance.

    24 April 2019

    Nitinol-based medical devices: Draft guidance from FDA
    “Technical considerations for non-clinical assessment of medical devices containing nitinol,” is the new draft guidance published by the FDA recently. The proposed recommendation which must be included by the manufacturers during premarket submission of nitinol containing devices is included in this draft guidance. Recommended tests to assess nitinol devices such as biocompatibility, performance under temperature and stresses, and susceptibility to corrosion are also included in the guidance.

    24 April 2019

    Premarket review required to reclassify surgical staplers as Class II devices: FDA
    There is a requirement of premarket reviews, performance studies and agency clearance to re-categorize the surgical staplers as higher-risk medical devices by FDA. Surgical staplers are used to stitch tissues together faster in comparison to manual suturing. These have been categorized as Class I-low risk surgical instruments since 1988 for general use.

    20 April 2019

    First medical device for treatment of ADHD in children approved: FDA
    “Technical considerations for non-clinical assessment of medical devices containing nitinol,” is the new draft guidance published by the FDA recently. The proposed recommendation which must be included by the manufacturers during premarket submission of nitinol containing devices is included in this draft guidance. Recommended tests to assess nitinol devices such as biocompatibility, performance under temperature and stresses, and susceptibility to corrosion are also included in the guidance.

    19 April 2019

    FIRST GENERIC NASAL SPRAY FOR OPIOID OVERDOSE TREATMENT: FDA
    The first generic spray, naloxone hydrochloride nasal spray has been approved by the FDA. It is a life-saving medication which is developed to reverse or stop the overdose impact of opioids. It has been stated by the FDA that there will be the development of new steps which can support in prior review of other generic drug applications which can be utilized in the treatment of opioid overdose.

    12 April 2019

    PoNS device by Helius Medical Technologies gets rejected by US FDA
    Premarket submission of Portable Neuromodulation Stimulator (PoNS) device manufactured by Helius Medical Technologies is rejected by US FDA due to insufficient data. This device would be involved in the restoration of neurological function through the delivery of neuromodulation to stimulate cranial nerves.

    12 April 2019

    FDA warns public not to use Unapproved Medical Devices for detection of Head injuries
    The US FDA has warned the public not to use unapproved Medical devices which claim the evaluation, detection or management of head injury such as traumatic brain injury. As per the FDA, they have not reviewed smartphone applications which claim their utilization during sporting injuries.

    11 April 2019

    Radiofrequency ablation device by Innoblative received FDA approval
    The electrosurgical device SIRA RFA by Innoblative Design has received clearance from the US FDA. This has been developed by the company to remove dysfunctional soft tissue with the use of heat generated medium frequency alternating current. This device is claimed to safely facilitate the appropriate removal of clinical targets.

    11 April 2019

    Reclassification of Medical Device Accessories to Class I by FDA
    Eight types of medical device accessories would reclassify to Class I by US FDA. The list of accessories included in final classification involves penile implant surgical accessories, Corneal inlay inserter handle, Biliary stent, drain and dilator accessories, Air-handling apparatus accessory, Suprapubic catheter accessories, Implanted mechanical/hydraulic urinary continence device surgical accessories, Gastroenterology-urology accessories to a biopsy instrument and Ureteral stent accessories.

    04 April 2019

    Breakthrough Device Designation to COPD system by FDA
    Unconditional Investigational Device Exemption (IDE) approval has been received by the company to start pivotal clinical study for the treatment of patients having moderate to severe chronic obstructive pulmonary disease with chronic bronchitis. A Metered Cryospray including liquid nitrogen at -196℃ is utilized in this system to target specific areas within lungs.

    02 April 2019

    Medical Transfer Adhesive by 3M for Wearable Medical Devices
    Extended Wear Medical Transfer Adhesive 4075 has been added by 3M in its innovative list of adhesives developed for wearable medical devices. Imparting patient-friendly adhesive options to design engineers is the major aspect of 3M’s mission. Extended wear pressure sensitive transfer adhesive is the distinguished feature of this adhesive. Exceptional initial skin adhesion for about 14 days depending upon the backing material is offered by this adhesive.

    01 April 2019

    Market Challenges at Global level for Medical Devices (2019-2025)
    The report has been prepared from 2014-2018 and it also includes the prediction from 2019-2025. Country or regional level reports for regions such as UK, Russia, South Korea, United States, China, Japan and India can be seen in report. Cycadia Health, Health Care Originals and Apple are the top companies involved in manufacturing Smart Medical Devices.

    25 March 2019

    Health Canada gives license to Elekta Unity MR-linac
    Magnetic resonance imaging by MR/RT system of Elekta is used to deliver radiotherapy in order to increase cancer treatment. Health Canada has given the license to firm to utilize this system as a Medical Device. The firm can now commercially sale the products. They are now waiting to receive the approval from Canadian Nuclear Safety Commission as well.

    23 March 2019

    USFDA is investigating the safety of using Breast implants
    Breast implants are utilized by several women either to rebuild or enlarge them. These are made up of silicone sacs which are filled with silicone gel or salt water. However, utilization of breast implants is associated with several concerns such as fatigue and debilitating joint pain. This has led to re-examination of its safety by researchers and USFDA.

    20 March 2019

    Advancement in Medical Devices: Seal verification Technology
    A seal verification Technology named as Insura is recently launched by Bemis Healthcare Packaging which has been specifically developed to pack medical devices. This is a non-destructive and real-time visual indicator to determine seal quality rooted into sterile barrier system. If the device is properly sealed, then it can generate blue colour.
    Rapid detection of brain disorder using new dopamine sensor
    A rapid dopamine detector has been developed by researchers of University of Central Florida which could assist in detection of brain conditions such as depression and Parkinson’s disorder. These disorders are associated with low levels of chemical dopamine. However, high dopamine levels are associated with several tumors which can be detected using new sensors.

    14 March 2019

    Valve repair device approval by FDA
    The MitraClip Delivery System, a heart valve repair device manufactured by Abbott Vascular Inc. receives FDA approval. The study was conducted on 614 patients who had mitral regulation followed by its approval from FDA. This device can be utilized to treat patients who have developed heart failure symptoms and mitral regurgitation.
    Medical Devices approved by FDA in 2019
    Scientists have developed an optical imaging system to detect tiny tumors deep inside the body. This has been developed by MIT researchers in the US and they named it “DOLPHIN”. DOLPHIN relies on NIR light and can trace through 0.1 millimetre fluorescent probe in a living mouse’s digestive tract.

    07 March 2019

    New optical imaging system to find tiny tumors
    Scientists have developed an optical imaging system to detect tiny tumors deep inside the body. This has been developed by MIT researchers in the US and they named it “DOLPHIN”. DOLPHIN relies on NIR light and can trace through 0.1 millimetre fluorescent probe in a living mouse’s digestive tract.

    27 February 2019

    Questions Answers for EU Medical Devices Regulation
    Practical considerations related with medical device implementation along with in vitro diagnostic medical devices regulations are included in Question and Answer document published by European Medicines Agency. This document can impart assistance to applicants regarding the various activities of agency.

    18 December 2018

    Health Canada issues draft guidance on Premarket device cyber security
    In order to help the manufacturers of the medical device in adhering to premarket cyber-security requirement, Health Canada posted new draft guidelines on Friday.
    Sale and distribution of Essure device to be discontinued in US by Bayer
    Pharmaceutical company Bayer has decided to stop selling its birth control product Essure in the US after 31st Dec 2018. US FDA imposed restriction on the marketing of the device on Bayer in April this year due to inadequate risk information and other requirements to ensure the device’s safety and effectiveness. However according to Bayer,”
    Pre-market approval by FDA given to Strykers flow diverter
    A Stryker is a medical technology company which has obtained pre-marketing approval from USFDA for the use of its Surpass Streamline Flow Diverter in treating unruptured large and giant wide-neck intracranial aneurysms. Surpass Streamline is already marketed in other international countries and is the second such device to get USFDA approval.
    Surgical Guidance Firm Endomag has received USFDA approval for breast cancer device called Magtrace
    Pre-market USFDA approval has been granted to Magtrace, the first non-radioactive dual-tracer device for lymphatic mapping in breast cancer patients manufactured by Surgical guidance firm Endomag. Currently breast cancer is treated through surgical removal of tumor and then a lymphatic mapping procedure to determine whether or not the cancer has spread to other parts of the body which usually involves the use of radioactive drugs and blue dyes having limited availability.
    AstraZeneca collaborates with Geisinger to develop an app for Asthma care
    Pre-market USFDA approval has been granted to Magtrace, the first non-radioactive dual-tracer device for lymphatic mapping in breast cancer patients manufactured by Surgical guidance firm Endomag.
    USFDA approval given to Medtronics less invasive approach to implant LVAD
    Medtronic is a global medical device company based in Dublin, Ireland providing medical technology, services and solutions. The company has received USFDA approval for its less invasive implantation procedure of the left ventricular assist device (LVAD) called HeartWare HVAD system. This will be helpful in cases of advanced, refractory hear failure patients.

    13 July 2018

    510(k) clearance to medical device company Embolx's pressure-directed arterial embolisation system granted by USFDA
    The embolisation therapy facilitates the delivery of drugs and embolic agents to the targeted treatment areas thereby protecting the surrounding healthy tissues.
    USFDA approval given to Zephyr Endobronchial Valve System developed by Pulmonx
    Zephyr Endobronchial Valve System has been designed by Pulmonx (an interventional pulmonology treatment provider) to treat severe emphysema, a type of chronic obstructive pulmonary disease (COPD).
    iStent inject Trabecular Micro-Bypass System developed by Ophthalmic medical technology company Glaukos received FDA approval
    Glaukos is an Ophthalmic medical technology company which has got the US Food and Drug Administration (FDA) premarket approval (PMA) for its iStent inject Trabecular Micro-Bypass System for the use of the system to decrease intraocular pressure (IOP) in adults with mild-to-moderate primary open-angle glaucoma (POAG) and undergoing concomitant cataract surgery.
    USFDA approval given to Eversense Continuous Glucose Monitoring (CGM) System of Senseonics
    Premarket Approval (PMA) application by USFDA has been granted to Senseonics Holding's Eversense Continuous Glucose Monitoring (CGM) System which is designed for diabetes patients. According to the company’s president and CEO Tim Goodnow," The FDA approval will allow to make Eversense available in the US, as it is available already in many European markets."
    Improvement in atrial fibrillation diagnosis observed with the use of home based ECG patch
    In almost 20% of individuals experiencing a stroke due to AFib, the occurrence of AFib is not diagnosed until the time of their stroke or shortly afterward. However if AFib can be recognized early then there can be an absolute risk reduction in all strokes of 2.7% per year for primary and 8.4% per year for secondary prevention, as well as a 0.5% per year absolute risk reduction in mortality.

    14 June 2018

    Regulation-on-ultrasound-machine-and-other-imaging-machines-to-be-made-more-strict-by-the-government-of-India
    It has been decided by the government of India to make the regulations more strict for ultrasound machines and other imaging equipments to prevent import of these equipments without proper registration.
    New medical device guidelines to contribute to 25-50% of the cost of medical devices procured by the government
    According to the proposal by the Department of Pharmaceuticals, domestically sourced components have to contribute to 25-50% of the cost of medical devices procured by the government.
    Optovue's OCTA blood vessel measurement technology approved by USFDA
    510(k) clearance from the US Food and Drug Administration (FDA) has been given to the AngioAnalytics, world’s first optical coherence tomography angiography (OCTA) blood vessel measurement technology to firm Optovue.
    A new minimally invasive medical device called Therepi developed to deliver medicine directly to heart
    A team of researchers including researchers from Harvard University and Massachusetts Institute of Technology (MIT) and National University of Ireland (NUI) Galway have developed a new minimally invasive medical device called Therepi that can be sutured onto diseased heart tissue to continuously deliver required drugs, proteins or stem cells.
    New test system launched by Abbott in US for management of Diabetes.
    New Afinion 2 analyser ,a rapid multi-assay platform to provide optimized and simplified results that are accurate and actionable at point-of-care has been launched in US by Abbott for Diabetes management.