FDA Issues Cybersecurity Alert About Vulnerabilities in Software Components

Unauthorized access could allow an attacker to take full control of the host operating system.
The post FDA Issues Cybersecurity Alert About Vulnerabilities in Software Components appeared first on MedTech Intelligence. Source: MedTech Intelligence…

U.S. MedTech, Healthcare Companies Not Immune to Cyberthreats Amid Russia-Ukraine War

Russia’s invasion of Ukraine has increased the potential for cyberattacks against U.S. healthcare systems.
The post U.S. MedTech, Healthcare Companies Not Immune to Cyberthreats Amid Russia-Ukraine War appeared first on MedTech Intelligence. Source: MedTech Intelligence…

Loftware Acquires PRISYM ID, Expands Enterprise Labeling Solutions for Medical Device and Pharmaceutical Companies

Clinical Trials Labeling and Regulated Content Management Added to Cloud-Based Platform
The post Loftware Acquires PRISYM ID, Expands Enterprise Labeling Solutions for Medical Device and Pharmaceutical Companies appeared first on MedTech Intelligence. Source: MedTech Intelligence…

Stryker to Acquire Digital Care Platform Vocera Communications for Nearly $3 Billion

“The deal will help Stryker significantly accelerate [its] digital aspirations to improve the lives of caregivers and patients,” according to company Chair and CEO Kevin Lobo.
The post Stryker to Acquire Digital Care Platform Vocera Communications for Nearly $3 Billion appeared first on MedTech Intelligence. Source: MedTech Intelligence…

FDA Issues Alert About Vulnerability in Apache Software

The agency is encouraging medical device manufacturers to evaluate their risk and take action to remediate any vulnerability.
The post FDA Issues Alert About Vulnerability in Apache Software appeared first on MedTech Intelligence. Source: MedTech Intelligence…

Biopharma and Medical Device Trends Investors Should Watch in 2022

For private equity and venture capital investors alike, there are five key trends presenting both headwinds and tailwinds that may impact investment flows into 2022.
The post Biopharma and Medical Device Trends Investors Should Watch in 2022 appeared first on MedTech Intelligence. Source: MedTech Intelligence…

EU MDR Compliance: Do Your CERs and PERs Hit the Regulatory Bar?

EU MDR Compliance: Do Your CERs and PERs Hit the Regulatory Bar?

MedTech Intelligence recently sat down with Peter O‘Blenis, CEO of Evidence Partners to discuss challenges reviewers face throughout their literature review process in the context of regulatory compliance, and to talk about the upcoming virtual event, Evidence Matters 2021.
The post EU MDR Compliance: Do Your CERs and PERs Hit the Regulatory Bar? appeared first on MedTech Intelligence. Source: MedTech Intelligence…

Smart Device Startup Data Challenge: Synch Building with Funding

Smart Device Startup Data Challenge: Synch Building with Funding

To achieve success, a medical device startup must build a sophisticated data architecture specifically designed to deliver maximum value for its customers’ use cases. However, it’s extremely difficult to build such an architecture—especially given early-stage budget constraints. That’s why startups must wisely synch their data architecture spending with their funding rounds.
The post Smart Device Startup Data Challenge: Synch Building with Funding appeared first on MedTech Intelligence. Source: MedTech Intelligence…

The Regulatory Aspects of AI/ML-based SaMD

Modern technology has given rise to new legal questions. How does FDA regulate machine-learning computers that are changing so rapidly – given that the approved product may be drastically different than the product that ends up on the market? These questions arise from a lack of understanding of the complex nature of AI/ML-based SaMD, the opaqueness of the regulatory framework, and a dearth of relevant case law.
The post The Regulatory Aspects of AI/ML-based SaMD appeared first on MedTech Intelligence. Source: MedTech Intelligence…

Cybersecurity by Design in Medical Devices

Medical devices and medical software are becoming increasingly connected to hospital networks, other medical devices or the Internet. As a result, manufacturers and developers are required to consider cybersecurity from the very early stages of development. This in turn necessitates comprehensive risk management along the entire lifecycle of a device.
The post Cybersecurity by Design in Medical Devices appeared first on MedTech Intelligence. Source: MedTech Intelligence…