In this week’s Digital Health Roundup, Medtech Insight’s Marion Webb talks about her interview with GE HealthCare’s chief AI officer Parminder Bhatia about his vision for AI in health care and other highlights from HLTH. Natasha Barrow discusses her interview with Owkin on the EU AI Act and highlights Click Therapeutics’ latest clinical results. —
Listen to the podcast below:
HLTH
Medtech Insight sat down with GE HealthCare’s chief AI officer Parminder “Parry” Bhatia at HLTH 2024 to learn more about the firm’s new offering CareIntellect for Oncology, which aims to help clinicians become more efficient by putting multi-modal patient data at their fingertips.
The company also announced the launch of its AI Innovation Lab, an R&D initiative with early projects in development such as Health Companion, a next-generation technology that is powered by agentic AI, which refers to AI designed to act autonomously by bringing clinical knowledge and problem-solving insights of a multi-disciplinary medical team to clinicians.
During a demonstration of Health Companion, Sundar Balasubramanian, GE HealthCare’s director of product strategy, explained the concept of a virtual tumor board where the oncologist and patient need to decide on upcoming treatment, which requires answering key questions, such as, “how is the disease progressing?” and “what is the current state of disease?” Traditionally, oncologists call on a multidisciplinary team of health care specialists, called a tumor board, to review and discuss the cancer case to help answer such questions. The board discusses factors like cancer type, stage, molecular characteristics, and patient health to determine the best pathway forward.
As always, HLTH attracted a slew of innovative companies. Medtech Insight highlighted seven start-ups in a round-up including OpenWater, Paige AI, Ferrum Health, Peerbridge, Linus Health, Epitel and Artisight.
Medtech Conference
During the Medtech Conference in Toronto earlier this month, industry leaders discussed how the latest innovations, including digital technologies, are rapidly changing the medtech landscape.
AdvaMed CEO Scott Whitaker, who hosted Citi Research managing director Joanne Wuensch, president and CEO of GE Healthcare Peter Arduini, Boston Scientific Corporation CEO Michael Mahoney, and Royal Philips CEO Roy Jakobs, said cutting-edge technology unimaginable just a decade ago is already transforming health care and saving lives.
The panel of leaders talked about monumental advancements, such as AI-driven glucose monitoring, once complex heart surgeries that are now minor procedures done in a day, tiny pacemakers that once were the size of car batteries, and treatments for neurological conditions and spinal cord injuries that once seemed out of reach.
The panel also discussed how digital technologies are advancing the ability to create and enhance health care in the home, which has enormous potential to increase access and equity, especially to the traditionally underserved.
Michelle Tarver has been named the new permanent director of the device center at the FDA, the agency confirmed last month.
Tarver has served as acting director of the Center for Devices and Radiological Health since July, when former long-term director Jeffrey Shuren said he was stepping down.
A practicing ophthalmologist, Tarver’s past work at the center has included leadership roles at the Office of Strategic Partnerships and Technology and the Patient Science and Engagement program, as well as serving as the deputy center director for transformation.
During remarks at the Medtech Conference in Toronto last month, prior to officially being named CDRH director, Tarver highlighted some of center’s priorities going forward, which include digital health.
For example, she said the center is looking to advance at-home care by making the home a “central hub” for health care, which could increase access for patients in inner cities and rural areas.
As part of the initiative, Tarver talked about an “idea lab” that could bring together the industry and CDRH to figure out ways to make devices and technology more suitable to the home, especially in low-income areas.
She also said the agency plans to hire an architect firm to build a prototype of homes that incorporate device designs. Tarver said the agency plans to unveil this initiative by the end of this year beginning with patients with diabetes.
Innovation
Among Medtech Insight’s innovative enterprise stories is Spain-based Inbrain Neuroelectronics, which reached a major milestone by announcing that surgeons at the University of Manchester, for the first time, used its graphene-based neural technology during a human brain surgery.
The brain-computer interface company plans to test its graphene-based device in up to 10 patients undergoing brain cancer surgery to show that graphene is safe when it comes with direct contact with the human brain, which it hopes will pave the way for eventual commercialization of a product that will do neural decoding and serve as a therapeutic.
Altoida CEO Marc Jones says while much of the attention has been focused on breakthrough drugs for treating Alzheimer’s disease, he believes their digital assessment technology will play a crucial role in determining, even before first symptoms appear, whether a case of mild cognitive impairment (MCI) will escalate into Alzheimer’s within a year.
Altoida’s tablet-based digital biomarker platform was granted Breakthrough Device designation by the FDA in 2021 for use as an adjunct to other diagnostic evaluations to predict disease conversion from MCI to Alzheimer’s disease within 12 months. It uses machine learning and augmented reality to assess disease progression.
AI has changed just about every tool imaginable, including one of the most foundational medical devices, the stethoscope. And AI-powered digital stethoscopes, according to three recent studies, have the potential to identify patients at risk of developing heart disease during routine cardiac screenings.
The results from the trio of studies, conducted by researchers at the Imperial College London and unveiled at the European Society of Cardiology (ESC), demonstrated that digital stethoscopes powered with artificial intelligence can detect evidence of cardiac disease in patients during routine screenings.
In the studies, Imperial researchers used Eko Health’s Low Ejection Fraction AI tool, which the company developed with the Mayo Clinic to find serious heart risks that often go undiagnosed.
Specifically, the study found that Eko’s AI could accurately predict changes in left ventricular ejection fraction (LVEF) — a critical indicator of heart function in heart failure patients.
Researchers say that patients who are able to monitor changes to LVEF from home could benefit from earlier interventions and personalized adjustments to their treatment plans, reducing the need for frequent hospital visits and providing peace of mind.
Digital Therapeutics
Click Therapeutics announced positive phase 3 trial results for its digital therapeutic designed as an adjunctive treatment for episodic migraine, CT-132. The device met the primary endpoint in the firm’s randomized, double-blind, controlled, decentralized study, demonstrating a statistically significant reduction in the treatment arm in a number of monthly migraine days compared to those receiving a sham digital control intervention. CT-132 was designated as a Breakthrough Device by the US Food and Drug Administration in 2022. Click is pursuing regulatory clearance for CT-132, in addition to actively investigating drug-digital combination therapy for patients following the positive results from the trial.
AI EU Act
Medtech Insight interviewed unicorn startup Owkin’s chief diagnostic officer Meriem Sefta and senior vice president of public affairs and impact Yedidia Levy-Zauberman to discuss how the company is adapting to the EU AI Act, the opportunity it presents, and what is needed next for AI deployment in the EU.
Since the company was founded in 2016, it has been set up with the idea of high standards for AI, said Levy-Zauberman. He didn’t view regulation as a priority challenge for the EU.
Rather, he called for more funding to support research and development of AI so the EU could compete on the same level as the US and China. Sefta explained that the implementation of the AI Act meant Owkin would have to clearly demonstrate that the AI model does what it claims to do and document it. The documentation aspect is something that will be new to the company, she explained.
