Tag Archives: Focus Article – Homepage

Sateesh Seethamariah

Creating a Connected Ecosystem: Challenges and Opportunities

By Sateesh Seetharamiah
Sateesh Seethamariah

Although 61% of decision-makers at healthcare organizations said their firms invested at least $100 million in digital transformation initiatives over the past year, 65% of those respondents said their firms have translated less than half of those investments into tangible business value. These numbers highlight the challenges of digital transformation with data siloes posing the biggest threat to success.

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Nick Recht

IQ OQ PQ and Its Role in Labeling System Validation

By Nick Recht
Nick Recht

Software validation is a critical tool used to assure the quality of device software and software automated operations, including labeling. Software validation can increase the usability and reliability of the device and label, resulting in decreased failure rates, fewer recalls and corrective actions, less risk to patients and users, and reduced liability to device manufacturers.

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Thomas Ring

Designing Compliant Wireless Medical Devices

By Thomas Ring
Thomas Ring

Medical Electronic Products of the future will be largely free from wires and cables, aside from a power source. “Wireless medical devices” offer numerous advantages. However, they are also subject to extensive legal regulations governing aspects such as the radio technology used in them. In addition, they may have to be assessed by a Notified Body such as TÜV SÜD.

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UK Flag

MHRA Announces New UK Approved Bodies

By MedTech Intelligence Staff
UK Flag

LNE-GMED UK has been designated as a UK Approved Body to assess and certify general medical devices in accordance with Part II of the UK Medical Devices Regulations 2002. Scarlet NB UK has been designated with a focus on assessing and certifying software and AI as a medical device (AI/SaMD).

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PreciseDX

How AI Can Advance Breast Cancer Detection and Treatment

By Ted M. Diehl, Wayne Brinster
PreciseDX

The integration of artificial intelligence (AI) into breast cancer detection and treatment is already making a profound impact. AI-powered algorithms enhance early detection by analyzing vast amounts of data and identifying subtle abnormalities often invisible to the human eye. These technologies empower healthcare professionals to make informed decisions, improving the accuracy of diagnoses and tailoring treatment plans to the specific genetic makeup and health conditions of individual patients. This integration represents a paradigm shift in the cancer care continuum.

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Karl Hoelper
Soapbox

Realizing RFID’s Potential in Healthcare: Tackling Closed-Loop System Hurdles

By Karl Hoelper
Karl Hoelper

The use of Radio-Frequency Identification (RFID) technology in healthcare, particularly within closed-loop systems, presents complexities, including potential limitations on interoperability that can affect patient safety. Here we look at key challenges including data silos, interoperability barriers, market fragmentation, impediments to innovation and operational inefficiencies.

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