For years, medtech firms around the globe (and certainly European companies) introduced their products in Europe, which requires obtaining a CE mark certifying compliance with relevant EU health and safety standards, prior to...more
3/11/2025
/ Certification Requirements ,
Data Protection ,
EU ,
Food and Drug Administration (FDA) ,
Health & Safety Standard ,
Intellectual Property Protection ,
Life Sciences ,
Medical Devices ,
Medical Technology Companies ,
Popular ,
Regulatory Requirements
Medtech mergers and acquisitions (M&A) and venture capital (VC) showed signs of life in 2024, contributing to an overall optimistic outlook for the sector this year despite lingering headwinds. Strategic investments are...more
Investor interest in the medtech sector is strong. According to DealForma and JPMorgan, medtech companies raised $16.1 billion from 544 funding rounds, including $3.3 billion from 244 seed and Series A rounds, through the...more
1/15/2025
/ Capital Raising ,
Corporate Financing ,
Early Stage Companies ,
Funding ,
Grants ,
Investment ,
Investment Opportunities ,
Life Sciences ,
Medical Devices ,
Private Equity ,
Small Business ,
Startups ,
Venture Capital
Investment in artificial intelligence (AI) is rising fast. The International Data Corporation projects global spending on AI R&D will reach $632 billion by 2028, more than twice the expected total for 2024....more
11/4/2024
/ Artificial Intelligence ,
Data Privacy ,
Innovative Technology ,
Intellectual Property Protection ,
Investment Opportunities ,
Life Sciences ,
Machine Learning ,
Med Tech ,
Medical Devices ,
Open Source Software ,
Patents ,
Research and Development ,
Risk Management ,
Software ,
Technology ,
Technology Sector ,
Trade Secrets ,
USPTO
Over the past decade, FDA approvals of artificial intelligence and machine learning (AI/ML)–enabled medical devices have surged. They reached a record high of 221 last year, according to data tracing back to 1995....more
Medtech companies are evolving rapidly as more and more of them develop products that collect and leverage substantial patient and provider data.
Companies that once only developed hardware-based solutions for...more
5/26/2023
/ Anti-Kickback Statute ,
Artificial Intelligence ,
Compliance ,
Cybersecurity ,
Data Collection ,
Data Privacy ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Food and Drug Administration (FDA) ,
Information Blocking Rules ,
Intellectual Property Protection ,
Med Tech ,
Medical Devices ,
Patent-Eligible Subject Matter ,
Popular ,
Safe Harbors ,
Software