Medical Device Newsletter

18-10-2019

All medical devices to be brought under CDSCO to improve safety & quality

 

As per the government plans, all medical devices, including implants and contraceptives are to be brought under the Central Drugs and Standard Control Organisation to ensure improvem

17-10-2019

US FDA approval to Secuado transdermal system of Noven Pharma for treating adults with schizophrenia

 

The US Food and Drug Administration (FDA) approval has been given to Secuado (asenapine) transdermal system which is the first-and-only transdermal patch formulation for the treatmen

15-10-2019

6 months transition time approval to implement provisions of new Medical Device Rules, 2017

 

A transition time of 6 months has been approved by the Union health ministry for implementing provisions of new Medical Device Rules, 2017 for the requirement of switching inventory

15-10-2019

US FDA approval to OssDsign for marketing Cranial PSI Accessories in US

 

The US Food and Drug Administration (FDA) has granted 510(k) clearance (K190523) for marketing OssDsign Cranial PSI Accessories in the US. The products which are cleared are a set of

14-10-2019

Guidelines on performance evaluation of IVDs for grant of manufacturing and import licenses issued by CDSCO

 

Guidelines has been issued by the Central Drugs Standard Control Organisation (CDSCO) for evaluation of performance of In-Vitro Diagnostic (IVD) medical devices for grant of manufact

09-10-2019

Breakthrough Device Designation for Heart Failure to Corvia Medical's Interatrial Shunt Device (IASD®)

 

A privately-held company, Corvia Medical, Inc., which has a first-in-class structural heart device for treatment of heart failure has received the Breakthrough Device designation by

07-10-2019

NHS approval to Genedrive for baby deafness trial test

 

Genedrive a molecular diagnostics firm has obtained approval from the NHS Health Research Authority and ethics committee for the usage of the Antibiotic Induced Hearing (AIHL) test i

04-10-2019

FDA Clearance to Biofourmis Analytics Engine for Ambulatory Physiologic Monitoring

 

Biofourmis has obtained 510(K) clearance for its machine-learning and artificial intelligence (AI)-powered analytics engine as a medical device for ambulatory physiological monitorin

12-09-2019

FDA clearance obtained by Healthy.io for mobile-based CKD test

The test of Healthy.io can be performed at pharmacies, urgent care centres and health clinics, which eliminates the need for a tabletop lab device.

Furthermore, the test can also present im

09-09-2019

FDA breakthrough device designation to Novel system for PAH

A breakthrough device designation has been granted by the FDA to a therapeutic intravascular ultrasound system for patients with pulmonary artery hypertension.

A therapeutic ultrasound cath

05-09-2019

Moderato system wins CE Mark for treating hypertension: Orchestra

Orchestra BioMed, Biomedical company has received European CE-Mark approval for its Moderato implantable pulse generator system to treat patients with hypertension.

Moderato functions with

02-09-2019

FDA granted breakthrough device designation to MagicTouch AVF sirolimus-coated balloon

FDA granted the breakthrough device designation for MagicTouch AVF, its sirolimus drug-coated balloon (DCB) catheter used for treating the stenotic lesions of arteriovenous fistulae or arteriovenou

31-08-2019

US FDA breakthrough device status to Conceptualize Medical's Sirolimus DCB catheter, MagicTouch AVF

Concept Medical Inc. (CMI) wins US Food and Drug Administration (FDA) grant as “Breakthrough Device Designation” for MagicTouch AVF, its Sirolimus drug-coated balloon (DCB) catheter, fo

28-08-2019

FDA approval to ApiFix MID-C system to treat adolescent idiopathic scoliosis

The US FDA has approved ApiFix for the commercialization of Minimally Invasive Deformity Correction (MID-C) system. This approval has been done through Humanitarian Device exemption for the treatme

23-08-2019

Minimally Invasive Deformity Correction (MID-C) System - H170001 wins approval: USFDA

Minimally Invasive Deformity Correction (MID-C) System gets the USFDA approval to treat adolescent patients having idiopathic scoliosis. The intention of non-fusion spinal device known as Minimally

22-08-2019

SAPIEN 3 Ultra Delivery System Recall by Edwards Lifesciences, LLC

The SAPIEN 3 Ultra delivery system of Edwards is being recalled by the organization. It is required for delivering and deploying the Edwards SAPIEN 3 Ultra transcatheter heart valve or the Edwards

21-08-2019

Centurion Medical Products' Primary Warmer Pack and Primary Set Pack Recall: Medline Industries, Inc.

An announcement has been made regarding the recalling of Medline Primary Warmer Pack and Primary Set Pack which is used to help in the administration of intravenous (IV) fluids. 

The M

21-08-2019

Centurion Medical Products' Primary Warmer Pack by Medline Industries, Inc. Recalled

An announcement has been made regarding the recalling of Medline Primary Warmer Pack, which is used to help in the administering of intravenous (IV) fluids. The Medline Primary Warmer Pack constitu

21-08-2019

MED-EL Cochlear Implant System - P000025/S104 wins USFDA approval

The MED-EL Cochlear Implant System gets the USFDA approval to produce auditory sensations. The intention of MED-EL Cochlear Implant System is to produce auditory sensations by giving electric stimu

20-08-2019

PD-L1 IHC 22C3 pharmDx - P150013/S016 wins USFDA approval

The lab test used by doctors for checking the protein programmed cell death ligand 1 (PD-L1) in tumor tissue obtained from patients, who have esophageal squamous cell cancer is done by PD-L1 IHC 22

19-08-2019

Medical device manufacturer can now ask for FDA feedback after inspection

The FDA has notified in a draft that in coming times, they will offer nonbinding feedback after completion of their inspection at medical device manufacturer.

The FDA explained the complete

18-08-2019

First spinal tether device wins the USFDA approval for treating idiopathic scoliosis

The US FDA has given the approval to first spinal tether device to be used in adolescents and children having idiopathic scoliosis. It is an alternative to surgical treatment.

The Zimmer Bi

16-08-2019

The Tether™ - Vertebral Body Tethering System - H190005 grabs USFDA approval

The USFDA approval is granted to the Tether-Vertebral Body Tethering system. The intention of non-fusion spinal device known as Tether™ - Vertebral Body Tethering System is to treat idiopathi

16-08-2019

Medtronic CoreValve System; Medtronic CoreValve Evolut R System; Medtronic CoreValve Evolut PRO System - P130021/S033 gets approval from USFDA

The USFDA gives the approval to CoreValue system developed by Medtronic. Three design iterations are present in the Medtronic CoreValve family of devices: the Medtronic CoreValve System (1st genera

16-08-2019

USFDA approves Edwards SAPIEN 3 Transcatheter Heart Valve System - P140031/S085

The SAPIEN 3 Transcatheter Heart Valve (THV) System and Edwards SAPIEN 3 Ultra THV System of Edward, both consist of an artificial catheter-based aortic heart valve and accessories used for implant

16-08-2019

BAROSTIM NEO System - P180050 wins USFDA approval

Barostim NEO system gets the USFDA approval to treat advanced heart failure. An implantable pulse generator (IPG), a carotid sinus lead kit and a programmer are included in the BAROSTIM NEO System.

15-08-2019

FDA Breakthrough designation to V-Wave's Interatrial Shunt regarding Device Designation for Heart Failure

A privately held medical device company known as V-Wave Ltd., developing new implantable interatrial shunt devices receives the Breakthrough Device Designation from the U.S. Food and Drug Administr

12-08-2019

Volumat MC Agilia Infusion Pump and Vigilant Agilia Drug Library Recall: Fresenius Kabi

Fresenius Kabi announced the recall of Volumat MC Agilia Infusion System which is an infusion pump used by health care professionals that delivers fluids including medications, blood, and blood pro

09-08-2019

NvisionVLE Imaging System wins FDA clearance

 

NvisionVLE Imaging System can now be marketed by NinePoint Medical following clearance from the US FDA. It can give high-resolution volumetric images of the sub

09-08-2019

CE marking to Meril Life Sciences for bioresorbable scaffold stent

Meril Life Sciences receives CE marking for their scaffold -MeRes100 BRS, becoming the first thin-strut bioresorbable scaffold. 

Cardiovascular related diseases such as coronary artery

09-08-2019

USFDA approves Medtronic CoreValve Evolut R System and Medtronic CoreValve Evolut PRO System - P130021/S058

Both of the sytems, the Medtronic CoreValve Evolut R System and Medtronic CoreValve Evolut PRO gets the USFDA approval. Both consists of a transcatheter aortic valve (TAV), a delivery catheter, and

07-08-2019

CE Mark approval wins by ExThera for Seraph 100

Seraph 100 by ExThera Medical, developed for pathogen reduction during bloodstream infection gets the CE Mark approval. Obtaining the CE mark approval confirms the safety of Seraph 100.

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05-08-2019

Abbott recalls Ellipse Implantable Cardioverter Defibrillators

Implantable cardioverter defibrillators with model numbers CD1377-36C, CD1377-36QC, CD1411-36Q, CD2377-36QC, CD2411-36C, CD2411-36Q manufactured between 05 April 2019 till 29 May 2019 are bein

05-08-2019

OncoBEAM RAS CRC kit gets Japanese approval

Sysmex Corporation achieves the Japanese approval to manufacture and market OncoBEAM RAS CRC Kit. It is used in the patients of colorectal cancer for blood-based circulating tumour DNA molecular te

05-08-2019

OncoBEAM RAS CRC kit gets Japanese approval

Sysmex Corporation achieves the Japanese approval to manufacture and market OncoBEAM RAS CRC Kit. It is used in the patients of colorectal cancer for blood-based circulating tumour DNA molecular te

02-08-2019

Medical device manufacturing sites will be audited by 6 bodies: CDSCO

According to the new MD Rules, the 6 bodies are notified by the CDSCO to audit the medical device manufacturing sites.

The new MD Rules 2017 became effective since 01 January 2018. These ru

02-08-2019

Filter Tips by QIAGEN recalled due to inaccurate or delayed results

1500 µl filter tips to be used with QIAGEN QIAsymphony SP/AS instruments, model number REF 997024 with lot number 0605020019 and 0605020020 are recalled due to delayed or incorrect results.

02-08-2019

FDA Draft guidance on Medical Device’s Safety in MRI Environment

A new draft guidance namely Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment has been issued by the U.S. Food and Drug Administration (FDA).

Unique

02-08-2019

USFDA: Green signal to PD-L1 IHC 22C3 pharmDx - P150013/S014

The USFDA grants green signal to PD-L1 IHC 22C3 pharmDX. The lab test used by doctors for checking head and neck squamous cell cancer having programmed cell death ligand 1 (PD-L1) in their cancer i

01-08-2019

Welch Allyn RetinaVue 700 Imager Launched by Hillrom

Hillrom launches the Welch Allyn RetinaVue 700 Imager, a retinal camera to detect diabetic retinopathy. It is a recent innovative diagnostic technology.

It helps distant ophthalmologists to

01-08-2019

Delivering accurate chest compression now becomes easy
The researchers from University of Applied Sciences and Fraunhofer Institute for Silicate Research have developed a device, named Rescue Aid. It assists in administering the ch

01-08-2019

Improvement in Powered Prosthetic Arms by Implanted Electrodes

In recent times, few built-in electrodes are present in conventional powered prosthetic arms that make connection with skin of the patient. These are good enough to open and close a simple claw, bu

01-08-2019

ECG, Breathing, Heart Rate measurement continuously for weeks using Flexible Body Monitor

Long-term continuous monitoring of physiological activity can impart precise information about an individual’s health. Children, elderly, and people with varied conditions often face difficul

01-08-2019

Rescue Aid to deliver accurate chest compressions

It is well known that perfectly delivered chest compressions can save an individual from cardiac arrest. However, this is not an easy task for the bystanders to perform the resuscitation because in

31-07-2019

Quality requirement draft on combination products: EMA

A draft guideline is published by the European Medicines Agency (MEA) on quality requirements for medical devices and medicinal products combination. This combination is also known as Drug device c

31-07-2019

Medical device’s encryption standards ‘needs to be compulsory’

An internet of things (IoT) company has warned that it is necessary to legally enforce the encryption standards on the medical devices. Encryption is mandatory for both developers and users. This i

31-07-2019

Johnson and Johnson’s faulty hip implants issue raised in Rajya Sabha

Anand Sharma, congress leader, requested the current government to make the regulatory norms more stringent so that the incident like Johnson & Johnson’s selling faulty hip implants shoul

30-07-2019

Aortix system of Procyrion received Breakthrough Device Designation from FDA

The Aortix system of Procyrion Inc. has secured the Breakthrough Device designation from the U.S. Food and Drug Administration (FDA). It is a percutaneous circulatory support system for medical-con

27-07-2019

Medtronic’s VenaSeal Closure System unveiled in India treat CVD patients

Medtronic Private Limited has launched its VenaSeal Closure System in India to treat the people suffering from chronic venous disease (CVD). It is an invasive procedure in which the diseased vein i

26-07-2019

MDTAG constituted by Health ministry

A Medical Devices Technical Advisory Group (MDTAG) has been constituted by the Union Health Ministry. The group will be giving advice to the Central Drugs Standard Control Organization (CDSCO) on m

25-07-2019

Bausch and Lomb’s faulty adrenaline auto-injector gets Regulatory warning

The UK MHRA has announced in the alert letter that about 0.23% syringe pens (2.3 pens in every 1,000) manufactured by Bausch & Lomb fails to deliver adrenaline’s dose due to needle blocka

24-07-2019

Microfluidics device developed for sepsis diagnosis

An automated, microfluidics device has been developed by the researchers from Massachusetts Institute of Technology (MIT) in the US. It will help in the detection of sepsis with 25 minutes.

23-07-2019

Medical Device Cybersecurity Recommendations drafted by France

The draft recommendations on the cybersecurity of medical devices have been developed by France’s National Agency for the Safety of Medicines and Health Products (ANSM).

These recomme

23-07-2019

All Intra-Aortic Balloon Pump models recalled by Maquet

The FDA has recognized the recall of Maquet/Datascope Intra-Aortic Balloon Pumps (IABP), models Cardiosave Hybrid, Cardiosave Rescue, CS300 and CS100/100i, as the Class Ⅰ recall.

IABP, a

23-07-2019

Medtronic to make Viz.ai’s AI stroke detection software

Medtronic, an Irish medical technology firm, has decided to make the artificial intelligence (AI)-based stroke care solutions provider Viz.ai’s new technology available to different centers i

23-07-2019

First cochlear device for single-sided deafness approved by FDA

Med-El North America, a Durham, N.C.-based firm has received an approval from the FDA for its cochlear implant system. This new device is first of its kind that can be used in people with single-si

16-07-2019

Digital Inhaler approved for Asthma patients: FDA

AirDuo Digihaler (fluticasone propionate 113mcg and salmeterol 14mcg), an inhalation powder, has been approved by the FDA. It is meant for asthma treatment in patients aged 12 years and older, but