Femtech stands at an exciting inflection point. What was initially perceived as a niche category focused on period-tracking apps has evolved into a comprehensive ecosystem addressing women's health needs with individualized...more
6/27/2025
/ Artificial Intelligence ,
Clinical Trials ,
FDA Approval ,
Healthcare ,
Investment ,
Investment Opportunities ,
Medical Devices ,
Mobile Apps ,
Mobile Health Apps ,
Regulatory Requirements ,
Software Developers ,
Technology Sector ,
Venture Capital
The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations and...more
1/15/2025
/ Artificial Intelligence ,
Comment Period ,
Compliance ,
Data Management ,
Draft Guidance ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Regulatory Requirements ,
Risk Management
regulators. The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) regulates medical devices, including software-as-a-medical-device (SaMD). Several years ago, the FDA upgraded its...more
It’s no secret that Democrats are traditionally trustbusters, but the Biden Administration is taking things to a whole new level, bringing novel—and arguably weak—cases that nonetheless slow or block tie-ups among healthcare...more
12/13/2023
/ Acquisitions ,
Antitrust Division ,
Biden Administration ,
Competition ,
Enforcement ,
Federal Trade Commission (FTC) ,
Healthcare ,
Healthcare Facilities ,
Hospitals ,
Medical Devices ,
Mergers ,
Pharmaceutical Industry ,
Regulatory Agenda ,
Regulatory Reform
The proliferation of health apps and connected devices that allow individuals to track their health conditions, treatment, medications, fitness, fertility, sleep, mental health, diet and other vital areas has led to increased...more
3/30/2023
/ Advertising ,
Breach Notification Rule ,
Civil Monetary Penalty ,
Data Collection ,
Department of Health and Human Services (HHS) ,
Enforcement ,
Federal Trade Commission (FTC) ,
FTC Act ,
Health Technology ,
HIPAA Privacy Rule ,
Medical Devices ,
OCR ,
PHI ,
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