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FDA Authorizes First Surgical Robot to Help with Transvaginal Hysterectomies

Mar 01, 2021

Combining Microfluidic Chip and Cellphone for Simplified COVID-19 Test

Mar 01, 2021

Could Even More M&A Be on the Way for Hologic?

Mar 01, 2021

Medtech in a Minute: The Robotics Company Formerly Known As TransEnterix, and More

Mar 01, 2021

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FDA Concussion Test Approval Signals Broad Advances in the Field

Feb 27, 2021

Tackling Startup Engineering Challenges in Medtech

Feb 26, 2021

Otsuka and Click Therapeutics Tap Verily to Go Remote with Trial

Feb 26, 2021

SteriPack Group Acquires HS Design and More Supplier News

Feb 26, 2021

Webinar Series: What's Next for Medtech Miniaturization?

Learn about the technological achievements that enable medtech miniaturization in this webinar series.

Highlights

surgical robot system (robotic-assisted surgical device)

FDA Authorizes First Surgical Robot to Help with Transvaginal Hysterectomies

Mar 01, 2021

Hominis is also the first robot-assisted surgical device with arms designed to replicate the motions and capabilities of a surgeon's arms...

What the Minerva Supreme Court Decision Could Mean for the Medical Device World and Beyond

Feb 25, 2021

Will the “assignee estoppel” doctrine survive future court decisions, or will other patent protections need to...

Medtronic Recalls Valiant Navion Due to Patient Safety Issue

Feb 25, 2021

Medtronic said three clinical trial patients were observed to have stent fractures. Two of the patients have...

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FDA Pivots on COVID-19 Guidance for Product Developers

Feb 23, 2021

FDA issued a new suite of guidances for developers of COVID-19 tests, vaccines, and therapeutics to address variants of the virus.

Medtech in a Minute: FDA's Flawed Testing Guidance, Liquid Biopsy, and More

Feb 22, 2021

Pressed for time? Here's the medtech news you need most, in one minute or less.

Humidity as a Use Condition for Accelerated Aging of Polymers

Feb 19, 2021

It is important to understand the impact of absorbed moisture content in polymers, as high or low levels could accelerate aging damage in many materials.

FDA Lays Out Flaws Made in Initial Antibody Testing Guidance

Feb 17, 2021

FDA’s Jeff Shuren, MD, and Timothy Stenzel, MD, discussed the flaws of the antibody testing guidance in a recently published editorial in The New England Journal of Medicine.

2020 Was a Record Year for Novel Medical Devices

Feb 17, 2021

FDA approved, cleared, or authorized a record high of 132 novel medical devices in 2020, surpassing the 40-year high set in 2017.

Why Risk-Based Thinking Is Essential in Medical Device Development

Feb 09, 2021

Many global regulatory requirements now include risk management, so medtech companies may need to revisit their quality system...

When Software Becomes a Medical Device

Feb 08, 2021

As digitalization increases all around us, computer programs have also been making their way into our healthcare system...

FDA Approves First Prosthetic Implant for Above-Knee Amputees

Feb 04, 2021

The OPRA Implant System has been on the market under a humanitarian device exemption since 2015 and is now fully approved by FDA for patients who have trouble with conventional socket prosthetics.

Boston Scientific Recalls Emblem S-ICD Electrode Due to Fracture Risk

Feb 03, 2021

There have been 27 complaints about this device issue, 26 reports of serious injuries, and one death has been reported.

Medtronic Wins Nod for Afib Treatment Device

Jan 29, 2021

The Dublin-based company inherited the DiamondTemp Ablation (DTA) system when it acquired Epix Therapeutics for $316 million in 2019.

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