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Category: Market Access

J&J’s Knee Surgery Robot Cleared for Expanded Use

In 2013, Stryker acquired Mako Surgical and has since maintained a leading position in the robotics field. In 2019, Zimmer Biomet's Rosa knee system received 510(k) clearance, entering the market. J&J took longer to enter the market, with its Velys product first receiving FDA clearance in 2021. Recently, the company has expanded the system's scope of use.

Pulsed Field Ablation Promises Rapid Adoption, Analysts Predict

Truist analyst Richard Newitter indicates that feedback from the Heart Rhythm Society (HRS) meeting suggests 50% to 70% of doctors will "immediately" adopt the technology.

Five Findings from the FDA’s List of AI Medical Devices

An increasing number of medical devices are incorporating artificial intelligence or machine learning (AI/ML) functionalities. The FDA updated its list of AI/ML-enabled devices on May 13, 2024, adding 191 newly approved devices, bringing the total to 882.

UK Proposes Recognition of Medical Devices Approved by Australia, Canada, EU, and US! To be Effective in 2025

On May 21, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) proposed allowing medical devices to enter the UK market, provided they are authorized in "comparable regulatory countries" (CRC), starting with the regulatory bodies of Australia, Canada, the EU, and the US, with Japan to be considered next. This draft is expected to take effect in 2025.

Safer Technologies Program (SteP) for Medical Devices

In 2021, the FDA established the "Safer Technologies Program" (STeP) to cover medical devices that do not qualify for the Breakthrough Devices Program.

SaMD Cleared for AI Pre-Screen for Low Bone Mineral Density

FDA Clears First OTC Continuous Glucose Monitor

The FDA cleared the first over-the-counter (OTC) continuous glucose monitoring system (CGM) on March 5, 2024.

95 Breakthrough Devices Approved So far to Hit U.S Market

FDA updated the Breakthrough Devices Program webpage to update the device designations data and the marketing authorizations list on March 21, 2024.

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