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Healthcare Newsletter

02nd August 2019

Rheumatoid Arthritis: Alarming disorder in Indians
Indians are advised and cautioned for early intervention of Rheumatoid Arthritis by healthcare experts.

24th July 2019

Allergan's textured breast implant recalled due to cancer association
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.

24th July 2019

Intra-aortic balloon pumps recall due to patients death
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.

23rd July 2019

Three ministries signed MoUs with Health ministry to end TB by 2025
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.

22nd July 2019

Elekta’s Unity MRRT system gets Canadian clearance
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.

19th July 2019

Security guidance for medical devices issued by Therapeutic Goods Administration
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).

18th July 2019

Burst balloon risk warning with Sapien 3 Ultra heart valve
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.

18th July 2019

Alaris Infusion Sets for Alaris Pump Model 8100 recalled by Becton Dickinson
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.

18th July 2019

Alaris Pump Module Model 8100 Bezel Assembly recalled by Becton Dickinson
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.

18th July 2019

Novian’s Novilase Breast Therapy gets European approval
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.

17th July 2019

Measles vaccination must for children in Germany
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..

17th July 2019

Intracranial Medical Device of Integra LifeSciences recalled
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.

17th July 2019

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

17th July 2019

Bi-Flow cannula introduced by LivaNova to prevent limb ischemia
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.

17th July 2019

NEONATAL ConchaSmart Breathing Circuit recalled by Teleflex
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.

16th July 2019

ICMR launches clinical trial for TB prevention vaccine
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.

16th July 2019

Inquiry ordered after patients alleges wrong Rantac Injection administration
After getting admitted at the Jhansi’s District Hospitals, the patients alleged that they were administered wrong medication leading to their health deterioration.

16th July 2019

Health Minister announced Initiatives for improving quality care to pregnant women
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

16th July 2019

Abbott’s new MitraClip G4 device approved by FDA
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.

16th July 2019

Hearing aids may protect against dementia
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.

16th July 2019

Marlborough firm’s muscle toning device for arms, calves approved by FDA
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.

16th July 2019

New Mandatory Reporting Requirements for Hospitals in Canada
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).

16th July 2019

WHO: High Sugar in Baby Food is alarming
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.

15th July 2019

First Medical Device Development Tool by FDA Received Qualification
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.

15th July 2019

26 samples as NSQ and 817 samples as SQ declared by CDSCO in random sampling
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.

14th July 2019

Health Minister announced Initiatives for improving quality care to pregnant women
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

13th July 2019

AIIMS and Ministry of Health to lead largest pan-India oral health survey
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..

12th July 2019

Giraffe Infant Warmers and Panda i-Res Infant Warmers Recalled by GE Healthcare
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.

12th July 2019

Hamilton-G5 Ventilators recalled
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.

12th July 2019

EpiPen developed for spinal cord injuries
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.

10th July 2019

Automatic external defibrillators (AED) approved by FDA
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.

10th July 2019

Smart tuberculosis diagnosis using new blood test
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.

10th July 2019

Blood flow monitor developed for heart surgery
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.

09th July 2019

To stop 100,000 cancer cases, HPV vaccines is offered to boys in UK
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.

08th July 2019

NHS NICE recommends gammaCore device use
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.

04th July 2019

Intelligent Catheter Navigation System developed by German researchers
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.

04th July 2019

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

04th July 2019

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

04th July 2019

Study suggests low breast cancer risk in early risers
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.

03rd July 2019

Economical OCT Retinal Scanner developed for Eye Screenings
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.

03rd July 2019

Crystallized Drugs to protect Implants against Immune attack
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.

02nd July 2019

New and revised documents released by IMDRF
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.

01st July 2019

IntraClude Intra-Aortic Occlusion Device Recalled by Edwards Lifesciences
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.

01st July 2019

SmartSite Syringe Administration Set recalled by Becton Dickinson
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.

01st July 2019

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

01st July 2019

Two guidance documents on MDR and IVDR by EC
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.

01st July 2019

Clinicians can ‘See’ Patient Pain using Augmented Reality System
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.

01st July 2019

Mini MRI scanner created by UK scientists to detect knee injuries
For the quick and accurate diagnosis of knee injuries, the researchers from Imperial College London has developed a mini MRI scanner.

01st July 2019

New medical device for tissue pH measurement during surgery
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.

01 July 2019

New medical device for tissue pH measurement during surgery
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.

28th June 2019

Bacterial lysate medicines only for prevention of recurrent respiratory infections
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.

28th June 2019

BIOMONITOR Ⅲ Injectable Cardiac Monitor Released by BIOTRONIK
BIOTRONIK has decided to upgrade its BIOMONITOR injectable cardiac monitor and is releasing BIOMONITOR Ⅲ to replace BIOMONITOR Ⅱ.

27th June 2019

enFlow Fluid Warming System Disposable Cartridges recalled by Vyaire Medical
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.

27 June 2019

New guidance for Medical Device Cybersecurity comes into effect in Canada
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.

27 June 2019

Health Canada to make medical device adverse event reporting mandatory
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.

21st June 2019

Hudson RCI Sheridan and Sheridan Endotracheal Tubes by Teleflex Medical recall: US FDA
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.

13 May 2019

3D Printed Medical Device: Health Canada issued new guidance
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.

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.

20 March 2019

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.

14 March 2019

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.

18 December 2018

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,”

18 December 2018

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.

18 December 2018

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.

18 December 2018

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.

18 December 2018

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.

13 July 2018

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).

13 July 2018

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.

13 July 2018

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."

13 July 2018

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.

14 June 2018

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.

14 June 2018

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.

14 June 2018

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.

14 June 2018

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.

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