Our Blog
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
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
Many companies treat product development as if it is equivalent to manufactur... 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... 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... While reusable devices significantly help in cost-cutting and optimization of hospital supplies; cross-contamination is a prevalent problem with these devices. Regulatory b... 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... While the preamendment devices can serve as excellent predicate devices, there are practical challenges associated while using such devices for approvals. One such example ... 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 ... 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... 
Postmarket Surveillance: An inescapable sound of noise
Product Development
Breath Analyzers – As Diagnostic Tools
Wearable ECG Monitor: Regulations, Standards and Guidance
Addressing Duodenoscope contamination – An FDA Initiative
Access to De Novo Summaries – A treasure for manufacturers
17 years Journey – Surgical Mesh for Transvaginal Repair of Pelvic Organ Prolapse (POP)
CLIA Database: A Centralized Database of Clinical Tests & Instruments
De Novo paving the path for Technological Advancements