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Testing Is Key to Turning an Innovative Idea into a Successful Commercial Medical Device

Jan 26, 2022

Is Abbott Looking for M&A Opportunities?

Jan 26, 2022

Distalmotion’s New Milestone Shows 2022 Will be Big for Surgical Robotics

Jan 26, 2022

Can Cloud-Based AI & Computer Vision Improve Endovascular Surgery?

Jan 26, 2022

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Products
Whitepapers

Robotics Likely the Future of Interventional Cardiology, Says R-Evolution Clinical Study Investigator

Jan 26, 2022

NextKidney’s New M&A Will Have Big Implications for Hemodialysis

Jan 26, 2022

Using Machine Learning in COVID-19 Diagnosis, While Preserving Privacy

Jan 26, 2022

Could a 2.8-g Implant (or Smaller) Change Neuromodulation?

Jan 26, 2022

U.S. Medtech Incubators and Accelerators

Check out these U.S. medtech incubators and accelerators organized by state.

Highlights

Extended Transitional Provisions for EU’s IVDR Expected Rather than a Delay

Jan 19, 2022

Revisions to the IVDR’s transitional provisions may grant some IVD manufacturers extra time for compliance, but there is much work to do.

Medtech in a Minute: Dexcom's 'Incredibly Impressive' G7 Data, and More

Jan 14, 2022

Quickly catch up on the latest medtech news from Dexcom, iRhythm, J&J, and others.

Practical Considerations for Draft Transition Plans for Devices Under EUAs or COVID Enforcement Policies

Jan 14, 2022

A close look at FDA's transition measures for devices under EUA's and COVID-19 policies.

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Australia Invests Big in Telehealth

Jan 12, 2022

The Australian government is investing A$106 million over four years to support permanent telehealth services, but the government has also made some reimbursement changes that many providers are unhappy with.

The Reimbursement Tide May Be Turning for iRhythm

Jan 11, 2022

Updated rates posted by Medicare Administrative Contractor Novitas may be a positive sign for the company.

Medtronic’s Shares Drop After Diabetes Unit Gets Warning Letter

Dec 15, 2021

The Dublin-based company’s diabetes business has suffered a bit in the past but a new product on the horizon could turn things around.

UKCA Compliance: What You Need to Know and Implement by June 2023

Nov 17, 2021

Stay up to date on these regulatory developments to continue to market medical devices in the United Kingdom.

FDA Is Back in the Driver’s Seat with LDTs

Nov 16, 2021

HHS just withdrew a Trump Administration-established policy limiting FDA’s ability to regulate laboratory-developed tests.

Is this the End of MCIT Payments for Breakthrough Devices

Nov 15, 2021

CMS has given a definitive answer on the future of the payment proposal.

Risk Management Means So Much More than EU Medical Device Regulation Compliance

Oct 19, 2021

Medical device companies can employ risk management for better project execution, better clinical and field experiences, and...

Get Ready for a Massive Shakeup in NIH Leadership

Oct 05, 2021

It’s the end of an era as Francis Collins, MD, PhD is stepping down as NIH director by the end of the year.

The Case for Clinical Adjudication in Medical Device Trials

Oct 04, 2021

Clinical adjudication could help medical device manufacturers address clinical trial issues before a trial even begins.

Medtech in a Minute: Antitrust Regulators Could Throw the Book at Illumina and Grail

Oct 01, 2021

It was a busy news week in medtech. Here's what you need to know to bring you up to speed quickly.

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