Tag: medical devices

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MedTech

What is MedTech all about?

You can read a lot about MedTech. There are websites (like disrupting healthcare), news resources, and companies focused on one thing. MedTech. But what is MedTech? What does a MedTech company do? Is Medtech in a hospital or can you have it at home, on your wrist, or inside your body?

To make your journey into the world of MedTech easier, let’s discuss basic facts about MedTech.

Photo by Natanael Melchor on Unsplash

What is MedTech?

It is just an ugly abbreviation. MedTech stands for medical technology. And as you can guess there are very many technologies in the medical sector.

What are medical technologies?

MedTech is a very wide subject, but it can be categorized into three categories.

  1. Medical Devices
  2. In-vitro Diagnostics (IVDs)
  3. Digital Health Solutions  and Digital Therapeutics (DTx)

What are Medical Devices?

Photo by Myriam Zilles on Unsplash

Medical Devices is yet another very wide term in the MedTech world. It covers any product, service, or solution used to prevent, diagnose, monitor, or treat people. As you can now understand, it can be literally anything, an instrument, appliance, software, implant, reagent, material, or even a service for processing some vital data. Under Medical Devices, you will find all known gadgets of the medical profession, syringes, needles, stethoscopes, big machines to perform X-Ray or MRI, or the special chair in your dentist. Wheelchairs and canes, and hospital beds are also medical devices. And of course, everything that can be put on or in your body in medical procedure – sensors, cardiac pacemakers, and so on.

To become a Medical Device and be used in a healthcare setting, an object or service has to meet certain regulations to ensure its safety and reliability.

What is In Vitro Diagnostics?

Photo by Testalize.me on Unsplash

In vitro means literally in the glass. In vitro diagnostics (IVD) is any diagnostic procedure taken outside of the patient body. It is a non-invasive test made on a sample taken from your body, used to determine the status of a patient’s health. The sample can be blood, urine, tissue, or saliva. COVID-19 tests are IVDs. IVD never comes into direct contact with a person, they provide information based on scientific measurement of the sample. IVDs are not used for treatment, they are supposed to inform patients and healthcare professionals to make decisions.

What is Digital Health?

Photo by Luke Chesser on Unsplash

Digital Health covers all tools and services that combine information and communication technologies in prevention, diagnosis, and treatment. Digital Health plays an increasingly important role in healthcare. It allows for gathering and analyzing health data on an unprecedented scale, allowing scientists to discover patterns and insights. Digital Health speeds up and facilitates research and development of new therapies. It also allows remote monitoring of vital signs, early prevention and diagnosis, and at-home or ambulatory treatment. Finally, there are specific Digital Health solutions called Digital Therapeutics (DTx). Digital Therapeutics is usually Software as Medical Device – or in layman’s terms software application, that can be prescribed and used as medicine. There are more and more such DTx available, we have been covering examples such as Deprexis and NOCD.

What is MedTech – summary


Now, you know what is MedTech! It is any technology that is used in healthcare. MedTech covers Medical Devices, In vitro Diagnostics and Digital Health Solutions. On disrupting.healthcare we discuss MedTech with a focus on Digital Health on the exciting journey to improve the health and well-being of patients around the world.  

Categories
Digital Health

Meet Troy Tazbaz, a new director of the FDA Digital Health CoE

Troy Tazbaz Linkedin profile. Source: Linkedin

Troy Tazbaz has been appointed as a Director of the Digital Health Center of Excellence at the FDA. Mr. Tazbaz combines a long career in IT with long and personal involvement in healthcare.

Most media outlets focus on Mr. Tazbaz’s recent career as a cloud infrastructure at Oracle and earlier at social software Ning. For us, however, the most important is his voluntary and very personal engagement in patient care, especially in Hematology and Oncology.

Since 2010 Troy Tazbaz has been involved in campaigning for The Leukemia & Lymphoma Society, a Patient Advocacy Group, and the largest nonprofit dedicated to fighting blood cancer. Since 1949, the LLS has donated over $1.6 billion to support research on leukemia, lymphoma, Hodgkin’s disease, and myeloma.

Mr. Tazbaz has very personal experience in oncology treatment and care. He was supporting his wife, Brynn Fowler in her patient journey as documented on her blog, The Millenial with Cancer. Mrs. Fowler was diagnosed with Stage IV Colon Cancer at the age 37. Now, after Mrs. Fowler has passed away, the website is still maintained by Mr. Tazbaz as The Continuum Diaries.

FDA DHCoE Infographics. Source: FDA.gov

FDA Digital Health Center of Excellence is part of the Center for Devices and Radiological Health (CDRH). It is responsible for envisioning a future of safe and effective healthcare delivery with a focus on advancing public health goals with the use of technology. It performs technology evaluation, policy development, and strategic partnerships, as well as maintains a network of Digital Health experts.



Categories
Digital Health

Artificial Intelligence and Machine Learning (AI/ML) in Medical Devices

Do you know that FDA already approved 521 Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices?  

PAPNET. The failure of the pioneering AI/ML-enabled test.

Five hundred apps may not surprise you in January 2023, given the noise around Open AI and its GPTChat. However, the first such device, PAPNET Testing System, was approved over 28 years ago. In 1995, the year of Johnny Mnemonic and Ghost in the Shell movies!

Fig.1 Neural net-based (PAPNET, Neuromedical Systems, Suffern, NY) display of squamous cells (Papanicolaou stain) from a balloon smear showing effects of radiotherapy. Marked cell enlargement and vacuolization of cytoplasm are easily recognized.
Source: Koss, Leopold & Morgenstern, Nora & Tahir-Kheli, Naveed & Suhrland, Mark & Schreiber, Katie & Greenebaum, Ellen. (1998). Evaluation of Esophageal Cytology Using a Neural Net–Based Interactive Scanning System (the PAPNET System): Its Possible Role in Screening for Esophageal and Gastric Carcinoma. American journal of clinical pathology. 109. 549-57. 10.1093/ajcp/109.5.549.

PAPNET was using a neural network to analyze and interpret cytology from Pap smears. While this early system generated a lot of interest and Google Scholar lists 217 peer-reviewed articles on PAPNET results, the business side of it was not that great. The cost-effectiveness of the system in comparison to manual screening by cytotechnician was not there. Neuromedical Systems Inc, the company behind PAPNET went bust in 1999, and now its intellectual property is a part of Becton, Dickinson and Company portfolio.

List of FDA-approved Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices

If you look at the list of approved AI/ML-enabled medical devices, you will notice that the vast majority (392 medical devices, 75% of the whole) are for Radiology. Cardiovascular (57,11%), Hematology (15, 3%), and Neurology (14, 3%) are the remaining three significant categories.

Fig. 2: Split of approved AI/ML-enabled medical devices by Specialty Panel.
Source: FDA.gov, graphics by disrupting.healthcare

There are only 15 companies that have more than five AI/ML-enabled medical devices approved. Five of those companies are actually subsidiaries of GE, which in total owns 42 AI/ML-enabled medical devices. Then there is Siemens with 27 devices, Canon with 15, Aidoc Medical with 13, and Zebra Medical Vision with 9 devices. Philips, which also submitted its devices via different subsidiaries has in total 10 approved AI-enabled devices

Table 1. Companies with over 5 approved AI/ML-enabled medical devices
CompanyAI/ML-enabled medical devices
GE Medical Systems42
Siemens Healthineers27
Canon17
Aidoc Medical13
Philips Healthcare10
Zebra Medical Vision9
Quantib BV6
Arterys Inc.5
Clarius Mobile Health Corp.5
HeartFlow, Inc.5
RaySearch Laboratories AB5
Viz.ai, Inc.5
Source: FDA.gov, disrupting.healthcare

The future of AI-enabled and data-driven MedTech

The market for Artificial Intelligence / Machine Learning – enabled Medical Devices seems to be poised for growth. At a recent HLTH 2022 conference in Las Vegas, Michelle Wu, CEO of NyquistData, a company offering an AI-supported intelligence platform dedicated to MedTech companies discusses the advantages of using AI to unlock the potential of unstructured data from medical devices.

Leveraging Artificial Intelligence, Data to Improve Medical Devices
Source: Xtelligent Healthcare Media

Cleerly. An example of an AI-enabled medical device for a heart-attack-free future.

A good example of upcoming Artificial Intelligence / Machine Learning – enabled Medical Device may be Cleerly. The startup has raised $279 million from investors including Fidelity, T. Rowe Price, Novartis and Peter Thiel.

Founded by cardiologist James Min, former professor at Weill Cornell Medical College and director of the Dalio Institute of Cardiovascular Imaging at New York-Presbyterian, Cleerly uses AI to improve diagnostics cutting down on the time it takes to flag patients at risk.

Its proprietary AI algorithms analyze CCTA images to generate a 3D model of patients’ coronary arteries, identify their lumen (the cavity or channel within a tube or tubular organ such as a blood vessel) and vessel walls, locate and quantify stenoses, as well as identify, quantify and categorize plaque.

Source: Cleerly