Amanda Pedersen, Senior Editor at MD+DI, reflects on the medical device and diagnostics industry in 2023, including challenges, layoffs, and positive surprises. They also discuss the conclusion of the Theranos saga, Phillips' ongoing recalls, the divestment of grail by Illumina, and the excitement for the future of PFA in Medtech.

Regulatory updates on laboratory-developed tests, artificial intelligence, and software discussed by an attorney. Mintz's role in helping medical device companies navigate FDA regulations, including AI and machine learning-enabled software. Importance of understanding FDA regulations for medical devices and software. Discussion on expectations for FDA's final rule on LDTs & AI. Impact of the EUMDR on companies and confusion surrounding compliance. Concluding thoughts on changing regulatory landscape.

Surbhi Sarna began her journey into medtech when she had a health scare at the age of 13. The ordeal led her to founding nVision, a company focused on the detection of ovarian cancer. nVision was eventually acquired by Boston Scientific. Sarna joins us shortly before her keynote at BIOMEDevice Silicon Valley to discuss her journey into medtech and what it takes to be an entrepreneur in the industry.

The podcast discusses the overall health of the MedTech industry, including revenue growth and financing challenges. It explores near shoring in the industry and the potential growth and barriers in the Chinese market. The speakers also make predictions for the medtech industry in 2024, focusing on R&D spending and the shift towards a direct-to-consumer model.

GE HealthCare started off 2023 by becoming a fully independent company. The company then wasted little time making acquisitions. Most recently, GE HealthCare was in the spotlight because of developments in Alzheimer's treatments that could potentially drive up the demand for the firm's imaging equipment. Jan Makela, President and CEO, of Imaging at GE HealthCare, joins us to talk about the company's success and how it plans to finish out the year, in this exciting new episode.

Guest Gregory Fischer, Founder & CEO of AiM Medical Robotics, discusses the surgical robotics landscape and the development of a compact, MRI-compatible surgical robot. They also explore the importance of procedural precision, advancements in surgical robotics, and the growing number of companies in this field.

Claire Smith, VP of global strategic marketing for Nevro, shares how the company's HFX iQ technology is using artificial intelligence to help treat chronic pain. Smith also shares some of her experiences in medtech sales and how the role of a medtech salesperson has changed over the years.

It's been a little more than a year since ZimeVie was launched from Zimmer Biomet. The dental and spine specialist has had to overcome some tough obstacles and find its footing. ZimVie's CEO, Vafa Jamali returns to Let's Talk Medtech to discuss the company's growth, tribulations, success, and why Europe has become a fertile market. You don't want to miss this exciting episode of Let's Talk Medtech.

Nicole Black, Phd., Vice President of Biomaterials and Innovation, at Desktop Health, drops by to discuss how new technological developments are transforming 3D printing from a method primarily used for prototyping into a reliable manufacturing method for end-use medical devices. Black is also a keynote speaker at BioMEDevice Boston, an event showcasing emerging technologies and trends from the medtech market, set to be held Sept. 20-21 at the Boston Convention & Exhibition Center.

Naomi Schwartz, the Senior Director for Cybersecurity Quality & Safety at Medcrypt, a medical device cybersecurity specialty firm, shares some interesting tidbits about FDA's upcoming Refuse-to-Accept (RTA) policy for Cyber Devices and Related Systems. The policy is effective Oct. 1 and Schwartz breaks down what the RTA will mean for medical device manufacturers and their FDA submissions.