Each week we highlight five things affecting the life sciences industry. Here’s the latest.
FDA approves at-home COVID/flu combo test for fall season
- The U.S. Food and Drug Administration has approved an at-home test by Healgen that detects both COVID-19 and influenza A and B, marking a significant milestone in over-the-counter diagnostics, reports Fierce Biotech.
- The Rapid Check test received de novo clearance, allowing it to be used without a prescription, and is designed for self-use by individuals aged 14 and up, or by adults for children as young as two.
New guidelines for pulse oximeters amid racial bias concerns
- CBS News reports that the FDA has released new guidelines for pulse oximeters to address racial bias, acknowledging that these devices often provide inaccurate readings for people with darker skin tones.
- The updated guidelines aim to improve the accuracy of pulse oximeters and ensure better health outcomes for all patients, particularly those from minority communities.
Surge in FDA approvals for AI medical devices
- The FDA has authorized nearly 1,000 artificial intelligence-enabled medical devices since 1995, with a significant increase in approvals over the past decade.
- In 2023 alone, the FDA approved 221 AI medical devices, driven by advancements in technology and increased investment in AI and machine learning, reports MedTech Dive.
Big Pharma’s growing interest in cell and gene therapy
- Large pharmaceutical companies are increasingly investing in the cell and gene therapy sector, positioning themselves as key players in commercializing these advanced therapies, which smaller biotechs often struggle to do due to high costs and complex processes.
- Recent investments include a $175 million Series B financing round for Capstan Therapeutics, reports BioSpace.
AI revolutionizes drug development in biotech and pharma
- AI is significantly impacting drug development, enabling smaller biotech companies to advance without relying heavily on Big Pharma, according to a report from S&P Global Ratings.
- The value of AI in pharma is projected to grow from $1 billion in 2022 to $22 billion by 2027, driven by increased investment and technological advancements, reports PharmaVoice.
For more insights in life sciences, check out RSM’s industry outlook.
