Digital Health

FDA updates pair of guidance documents relaxing its posture on how it regulates general wellness devices and clinical support software. Industry mostly welcomes changes, agreeing with agency’s view that lighter regulation will help spur innovation.

Healthtech companies seek to optimize the opportunity of AI while navigating a thicket of requirements from providers as well as regulations like the EU MDR. Andrew Davies, digital health lead at the Association of British HealthTech Industries, explained the importance of streamlining AI processes.

FDA Commissioner Marty Makary announced new guidance documents on wellness products and decision support tools focused on AI technology at CES in Las Vegas. The documents aim to reduce regulatory hurdles and promote innovation while ensuring public safety.

Hanmi Pharm Group announces new mid-term strategy including expansion of its obesity focus to aging with goal of more than doubling revenue by 2030 and becoming a true global player.

Brain-computer interfaces advance toward trials and commercialization, Oura pushes for FDA-cleared blood pressure monitoring, and regulators weigh AI’s expanding role in mental health and diagnostics amid rising safety concerns.

India is transforming its medtech sector from a consumer-importer market into an innovator-exporter industry. But stakeholders are aware of a public-private investment imbalance, In Vivo notes in part three of its APACMed 2025 conference report.

Corporate venture arms can be powerful growth partners, but founders who don’t take time to understand them risk missing their greatest value.

India is transforming its medtech sector from a consumer-importer market into an innovator-exporter industry. But stakeholders are aware of a public-private investment imbalance, In Vivo notes in part three of its APACMed 2025 conference report.

Legal and other experts discuss the need to plug data privacy and regulatory gaps and address prescription shortcuts at e-pharmacies. Collaborative models with brick and mortar chemists were also proposed.

The unwieldy application demands of the EU’s bunch of interconnected data regulations are creating headaches for the medtech industry.

EU industry association MedTech Europe fears a repeat of MDR/IVDR implementation chaos without immediate clarity over timelines for the readiness of the AI Act’s essential structures and documents.

Legal and other experts discuss the need to plug data privacy and regulatory gaps and address prescription shortcuts at e-pharmacies. Collaborative models with brick-and-mortar chemists were also proposed.