Our Blog

June 9, 2021

Modernization of 510(k) – A major milestone to safer and better healthcare

More than 190,000 distinct medical devices are regulated by the FDA. Data from the years

June 3, 2021

Postmarket Surveillance: An inescapable sound of noise

Are you a Medical Device Manufacturer? an employee of a medical device company? Or perhaps someone with an interest in Medical Devices. If yes, then

June 3, 2021

Product Development

Many companies treat product development as if it is equivalent to manufactur...

June 3, 2021

Breath Analyzers – As Diagnostic Tools

Breath Analyzers are one of the modern innovative devices that have emerged with the intent to improve healthcare and revolutionize the conventional diagnostic methods.&nbs...

June 3, 2021

Wearable ECG Monitor: Regulations, Standards and Guidance

Wearable ECG monitors have changed the face of cardiac patient care. The device provides patients with mobility, increased freedom, convenience and ability to record ECG wi...

June 3, 2021

Addressing Duodenoscope contamination – An FDA Initiative

While reusable devices significantly help in cost-cutting and optimization of hospital supplies; cross-contamination is a prevalent problem with these devices. Regulatory b...

June 3, 2021

Access to De Novo Summaries – A treasure for manufacturers

The De Novo pathway by the US Food and Drug Administration (FDA), is a risk-based classification process to classify novel medical devices for which there are no legally ma...

June 3, 2021

17 years Journey – Surgical Mesh for Transvaginal Repair of Pelvic Organ Prolapse (POP)

While the preamendment devices can serve as excellent predicate devices, there are practical challenges associated while using such devices for approvals. One such example ...

June 3, 2021

CLIA Database: A Centralized Database of Clinical Tests & Instruments

Diagnosis plays a vital role in curing a disease. If the diagnosis itself is wrong, the disease cannot be treated. Osteosarcoma, a dangerous but common form of bone cancer ...

June 3, 2021

De Novo paving the path for Technological Advancements

While there existed many computerized and digital tomographs with specific applications (Trauma CT, Cardiac CT, CT used in Nuclear Medicine / PET), there has never been one...