The Vitals 006: Big FDA News, 23andme DNA Data Drama & Game-Changing AFib Treatment

New Head of FDA: Michelle Tarver’s Patient-First Vision Brings Fresh Focus to MedTech

Michelle Tarver has been named as the permanent director of the FDA’s Center for Devices and Radiological Health (CDRH), taking over from longtime leader Jeff Shuren. Tarver’s background as an ophthalmologist and epidemiologist brings a focus on patient engagement, collaboration, and evidence-based decisions. 

Tarver is committed to boosting collaboration with a strong focus on ensuring patient needs are prioritized. Tarver’s experience in strategic initiatives and creating new pathways could facilitate a more transparent process and support creative, evidence-based innovations. 

Senior Regulatory Specialist Ken Meyer POV: Michelle Tarver's appointment as FDA Director signals a continued focus on innovation and streamlined device approvals, with a unique emphasis on the patient experience. 

Manufacturers should keep a close eye on the progress of the new draft guidance on incorporating voluntary patient preference information—a move that could shape future expectations in design, validation, and post-market activities. Only time will tell how a patient-driven perspective will reshape the MedTech industry. 

---

23andMe Faces Shut Down: What’s Next for Your Genetic Data?

23andMe, once a genetic data giant, is now facing a possible collapse after plummeting stock value, a major cyberattack, and a large number of board resignations. As the company looks into selling, users are concerned about what will happen to the genetic data of millions. 

VitaTek POV: At VitaTek, data security is a top priority in developing devices that handle sensitive information. We use modern technology with advanced security standards to protect patient privacy, ensuring that patient data remains safe and managed with the utmost integrity throughout the development and lifecycle of our products.

---

Featured Innovation: Farawave Nav

Boston Scientific’s Farawave Nav has hit the market with FDA approval, and it’s set to transform how we treat paroxysmal atrial fibrillation (AFib). This breakthrough system combines advanced cardiac mapping and pulsed-field ablation (PFA) into a single, integrated catheter—something no other device offers. 

Farawave Nav is redefining precision in AFib treatment, giving physicians unparalleled control and accuracy. With this all-in-one solution, Boston Scientific is leading the charge toward fully integrated, cutting-edge cardiac care. 

President of R&D & Engineering Rich Thompson POV: New technologies, like Boston Scientific's PFA ablation system, offer significant advantages for patients and a unique product that stands out in a competitive marketplace. 

At VitaTek, all the devices we develop are novel, unique devices with innovative features and technology, which strengthens our products' success in the competitive landscape and builds lasting value for our clients. 

---

Brekka’s First Step Towards International Distribution

President of Sales Matt Newman POV: We’re thrilled to announce our new international distributor partnership, marking a pivotal step in expanding our reach for the Brekka 2-in-1 Implant Delivery Device. 

Building on our first international distribution agreement in Taiwan, this collaboration opens doors to new territories in the Middle East, bringing VitaTek’s commitment to quality healthcare solutions to even more markets. 

We are also looking forward to connecting with additional International Distributor partners next month at the MEDICA conference in Germany.

---

See you at MEDICA!

Join us at MEDICA in Düsseldorf, Germany, from November 11-14 at Booth # 15G24-7.

Stop by to see firsthand how we bring devices to market 70% faster and at 70% of the cost—disrupting the standard in MedTech!