Indians are advised and cautioned for early intervention of Rheumatoid Arthritis by healthcare experts.

Allergan Inc. issued textured breast implant recall because of its linkage with rare cancer. Rare lymphoma cases in disproportionate amount were observed by the company resulting into textured breast implant recall.

Failing batteries to hold charge and unexpected stoppage leads to their recall by Maquet/Datascope. It is Class 1, most serious type recall as per the FDA.

Memorandum of Understanding (MoUs) has been exchanged by Union Ministry of Health and Family Welfare with the Ministry of Defence and Ministry of Railways to strengthen inter-ministerial coordination and efforts towards Tuberculosis-free India by 2025.

Elekta, a precision radiation medicine solution provider, has received regulatory clearance from the Canadian Nuclear Safety Commission for clinical use of its Unity magnetic resonance radiation therapy (MRRT) system.

New guidelines for the security of medical devices and in vitro diagnostic (IVD) medical equipment has been published by Australia’s Therapeutic Goods Administration (TGA).

Edwards Lifesciences has warned the doctors about the low risk of burst balloons during its Sapien 3 Ultra replacement heart valve’s implantation. Physicians are also cautioned to closely follow the instructions for use to avoid the problem.

Becton Dickinson is recalling the Alaris Pump Model 8100 Infusion Sets and the FDA has identified this as class Ⅰ recall, the most serious type of recall.

Becton Dickinson (BD) (CareFusion 303, Inc.) has decided to recall Alaris Pump Module Model 8100 Bezel Assembly manufactured between April 2011 and June 2017. The FDA has identified this recall as class Ⅰ recall, the most serious type of recall.

Novian Health, a US-based medical device maker, has secured CE-Mark approval to market its Novilase Breast Therapy in the European Union and Switzerland.

The Chancellor Angela Merkel’s cabinet has decided that Germany will make measles vaccination mandatory for children from March 2020, with an aim to wipe out the resurgent and potentially deadly disease..

In May 2019, the USFDA announced a class Ⅰ recall of Integra LifeScience’s LimiTorr Volume Limiting Cerebrospinal Fluid (CSF) Drainage System and its MoniTorr Intracranial Pressure (ICP) External CSF Drainage and Monitoring Systems.

The novel walrus Balloon Guide Catheter (BGC) from Q’Apel Medical has received USFDA clearance.

LivaNova, UK-based medical technology firm, has introduced the CE-Marked Bi-Flow arterial femoral cannula intended for the prevention of leg ischemia during cardiac surgery.

Teleflex is recalling NEONATAL ConchaSmart Breathing Circuit with Dual Heated Limb and ConchaSmart Column, product codes 870-07KIT, 870-09KIT, as the FDA identified it as class Ⅰ recall.

The Indian Council of Medical examination launched a clinical trial for a vaccine meant for preventing the TB occurrence among close contacts of a TB case patient. It is an important step in prevention and decreasing the burden of this disease.

After getting admitted at the Jhansi’s District Hospitals, the patients alleged that they were administered wrong medication leading to their health deterioration.

The Union Minister of Health and Family Welfare informed the parliament about the steps taken by the government to ensure quality care to pregnant women and neonates and provided the number of Mother and Child Health (MCH) wings that have been set up and are operational across the country. Some of the initiatives announced are

Abbott’s MitraClip G4 heart valve repair device has been approved by the US Food and Drug Administration (FDA) for treatment of patients with mitral regurgitation.

According to an online study conducted by University of Exeter and King’s College London, wearing a hearing aid to address age-related hearing problems may even help in better functioning of the brain.

A new muscle-toning device, namely EMSCULPT, from Marlborough medical device firm BTL Industries previously approved for the abs, butt and thighs got the USFDA’s approval to help tone up the arms and calves.

The federal government adopted new mandatory reporting requirements for hospitals across Canada under the authorities granted by the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law).

According to World Health Organization report, baby food contains too much sugar and is incorrectly advertised as suitable for infants under 6 months of age.

The USFDA has developed the first medical device development tool (MDDT), which is a tissue mimicking material (TMM) used in the preclinical development and evaluation of ultrasound medical devices. The MDDT received the FDA qualification as well.

After analysis and testing of 843 samples last month as part of random sampling, Central Drugs Standard Control Organization (CDSCO) declared 817 samples as standard quality (SQ) and 26 samples as not of standard quality (NSQ), spurious and misbranded.

The Union Minister of Health and Family Welfare informed the parliament about the steps taken by the government to ensure quality care to pregnant women and neonates and provided the number of Mother and Child Health (MCH) wings that have been set up and are operational across the country. Some of the initiatives announced are

This year, the AIIMS Centre for Dental Education and Research along with Ministry of Health will undertake the largest nationwide oral health survey to collect data, that would act as a baseline for planning preventive and treatment strategies..

The products Giraffe Infant Warmers and Panda i-Res Infant Warmers, model numbers 2063568-001-XXXXXX, 2063570-001-XXXXXX, M1112198-XXXXXX and M1118179-XXXXXX, have been recalled by GE Healthcare and the FDA has identified the recall as class Ⅰ recall.

Hamilton Medical AG has initiated the recall of Hamilton-G5 Ventilator (PN 159001) and the FDA has identified this as class Ⅰ recall, the most serious type of recall.

Researchers from University of Michigan has created an ‘EpiPen’ of nanoparticles, which could prevent Paralysis from spinal cord injuries by controlling the body’s immune system from overreacting to trauma.

AEDs like the HeartStart OnSite (M5066A) and HeartStart Home (M5068A), Primary Battery (Model M5070A), SMART Pads Cartridges (Adult Model M5071A) and Infant/Child (Model M5072A) has been approved by the FDA to market these products.

In a UK based study, a new blood test shown the potential to diagnose human tuberculosis (TB) and identify people who are at the highest risk of developing the disease.

A new micro-medical device has been developed by the researchers at Flinders University in Australia. The device will be used to continuously monitor blood flow during heart surgeries.

The UK officials said that around 100,000 cancer cases of mouth, anus, cervix, and genitals can be prevented in Britain in the next 40 years by a human papillomavirus (HPV) vaccine.

A draft guidance recommending the use of electroCore’s gammaCore device on the National Health Service (NHS) has been published by UK’s National Institute for Health and Care Excellence (NICE). The guidance covers use for cluster headaches.

The researches from Fraunhofer Institute for Digital Medicine MEVIS, Germany has developed a catheter system namely Intelligent Catheter Navigation (IntelliCath). This will help in precise navigation through the vasculature.

The health department launched the statewide vaccination drive for Rota virus from Phulwari Sharif primary health care (PHC).

The researchers have warned the people living with HIV infection about higher risk of developing cardiovascular diseases (CVD) like heart failure and stroke.

A study has found out that the women who are early risers have a low risk of developing breast cancer than those who woke up late. The researchers used Mendelian randomization technique to analyze genetic variants of three sleep traits- morning or evening preference (chronotype), sleep duration and insomnia.

A new less expensive and portable optical coherence tomography (OCT) retinal scanner has been developed by the researchers from Duke University. They tested the device on 60 patients with and without retinal diseases and found out that the image quality of their device is about 95% in comparison to other expensive devices, that makes it enough for diagnostic purpose.

Many of the implantable medical devices that interacts with human body are prone to the immune system’s foreign body response (FBR). This results in the creation of scars around the implant and its functionality decreases with time. Now, to avoid this serious localized immune reaction, scientists from MIT have developed a new way to embed crystallized immunosuppressant drugs into implantable devices.

Following a meeting in March, the International Medical Device Regulators forum (IMDRF) posted four new documents on unique device identification (UDI) and labeling rules, and four revised documents on standard operating procedures (SOPs), the Table of Contents (ToC) format and adverse events.

Edwards Lifesciences has recalled the IntraClude Intra-Aortic Occlusion Device with Model number ICF100 and UDI code (01) 00690103190007 after the FDA identified it as Class Ⅰ recall.

The Becton Dickinson & Company has recalled its SmartSite Syringe Administration Set with the Model number 10798696. The FDA has classified it as Class Ⅰ recall; most serious type of all the recalls.

https://www.igmpiindia.org/CE-mark-and-regulatory-approval-for-wood-based-wound-dressing.html

The European Commission (EC) released two new guidance on MDR/IVDR. One of them is for the persons responsible for regulatory compliance under the Medical Device Registration (MDR) and the in vitro Diagnostic Device Regulation (IVDR) and the another one is on implant card required by MDR.

To help clinicians to “see” patient pain in real time, the researchers from the University of Michigan have developed a new system. This new technology has the potential to objectively measure and identify pain in patients who can not communicate their symptoms.

For the quick and accurate diagnosis of knee injuries, the researchers from Imperial College London has developed a mini MRI scanner.

Wideblue, a product design, development and manufacturing consultancy has developed a device for Softcell Medical which is used to measure and display the pH of a patient’s tissue during surgery in real-time.

Wideblue, a product design, development and manufacturing consultancy has developed a device for Softcell Medical which is used to measure and display the pH of a patient’s tissue during surgery in real-time.

EMA has instructed that, from now onwards the bacterial lysate medicines should only be used against recurrent respiratory infections, with pneumonia as the only exception. This step was taken after reviewing that there is no robust data that can prove these medicines are effective in treating existing respiratory infection or prevention of pneumonia.

BIOTRONIK has decided to upgrade its BIOMONITOR injectable cardiac monitor and is releasing BIOMONITOR Ⅲ to replace BIOMONITOR Ⅱ.

Vyaire Medical has initiated the recall of the enFlow Fluid Warming System Disposable Cartridges, Models: 980200EU enFlow - Disposable Cartridge and 980202EU enFlow - Disposable Cartridge with IV Extension Set.

Health Canada’s new premarket requirements on medical device cybersecurity came into the force, following the adoption of its final guidance draft earlier this month. Under new guidelines, the manufacturers must identify and analyze hazards related to their medical devices to set controls and monitor their effectiveness.

Health Canada released new guidelines that will make the reporting of medical device incidents by Canadian hospitals mandatory within 30 days once the regulations come into force. The action was taken to address medical device safety and regulation.

Teleflex Medical has initiated Hudson RCI Sheridan and Sheridan Endotracheal Tubes recall. Select Sheridan® branded Endotracheal Tubes and Connectors EIF-000361 and the products with sizes 6.0, 6.5, 7.0, 7.5, 8.0 and 8.5 mm will be recalled.

A new guidance has been issued by Health Canada for 3 D printed medical device manufacturers. It contains the information which must be included in the license application of a 3D printed Medical Device. Material controls, design and manufacturing processes, testing and labeling recommendations for manufacturers who are dealing with Class III and IV implantable devices are covered in this 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.

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.

“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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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,”

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.

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.

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.

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.

The embolisation therapy facilitates the delivery of drugs and embolic agents to the targeted treatment areas thereby protecting the surrounding healthy tissues.

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).

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.

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."

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.

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.

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.

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 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 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.