Novel Medical Devices

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In 2020, FDA Authorized 132 Novel Medical Devices

https://www.medtechintelligence.com/news_article/in-2020-fda-authorized-132-novel-medical-devices/

The record-high number of authorizations last year was a significant jump over 2019. In 2009, FDA authorized just 29 novel devices; in 2015 it authorized 86; and five years later the number hit 132 novel devices. 2020 was a year for innovation, but the …

Reflections on a Record Year for Novel …

https://www.fda.gov/news-events/fda-voices/reflections-record-year-novel-device-innovation-despite-covid-19-challenges

Of the 625 EUAs the FDA issued for medical devices in 2020, such as tests and sample collection devices, personal protective equipment (PPE), ventilators, and other types …

Top 10 Medical Innovations for 2022 Unveiled – Consult QD

https://consultqd.clevelandclinic.org/top-10-medical-innovations-for-2022-unveiled/

Next generation of mRNA vaccinology. Advancements in the generation, purification and …

A Rundown of New Medical Devices Brought to Market …

https://www.goodrx.com/classes/medical-supplies-and-devices/best-new-fda-medical-devices-of-2020

The FDA approved, cleared or authorized a record number of novel (new) medical devices in 2020. Of the 132 new devices brought to market in 2020, many were …

The 18 most innovative medical devices of …

https://www.medicaldesignandoutsourcing.com/the-18-most-innovative-medical-devices-of-2021/

This year, the foundation nominated 18 medical devices, 21 biotechnology products, 34 pharmaceutical agents and 10 digital health products. The …

2020 Was a Record Year for Novel Medical …

https://www.mddionline.com/regulatory-quality/2020-was-record-year-novel-medical-devices

Despite the challenges brought on by the COVID-19 pandemic, 2020 was a record year for novel medical devices, FDA said Monday. Jeff Shuren, MD, …

FDA anticipates fewer novel medical device approvals in 2022

https://www.fiercebiotech.com/medtech/fda-anticipates-fewer-novel-medical-device-approvals-2022

FDA anticipates fewer novel medical device approvals in 2022 Fierce Pharma Fierce Biotech Fierce Healthcare Fierce Life Sciences Events Research Biotech Medtech CRO …

U.S. Marketing Authorization of Novel …

https://incompliancemag.com/article/u-s-marketing-authorization-of-novel-medical-devices/

An innovative medical device with either a new intended use or novel fundamental technology, even if its use is probably low-risk, automatically falls …

Medicine in Novel Technology and Devices - ScienceDirect

https://www.sciencedirect.com/journal/medicine-in-novel-technology-and-devices

Medicine in Novel Technology and Devices is a peer-reviewed open access journal. The journal publishes cutting-edge approaches, techniques and instruments which serve …

How to Determine if Your Product is a Medical Device | FDA

https://www.fda.gov/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device

Introduction Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers, and closed loop artificial pancreas …

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