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FirstWord MedTech's Digital Ten is a fortnightly round-up of the 10 most read and noteworthy headlines related to digital health, including industry deals, alliances, collaborations, innovations and R&D news.
FDA’s new guidance documents to provide more clarity to digital health innovators
The US FDA has issued six guidances - one draft and five finalised documents - related to digital health technologies. "Our aim is to provide more clarity on our risk-based approach to digital health products, and, in particular, to provide more detail on those technologies and applications that would no longer be classified as a medical device subject to FDA regulation according to the Cures Act," stated FDA Principal Deputy Commissioner Amy Abernethy. The draft guidance relates to clinical decision support software; CDS software account for a large and growing proportion of the digital innovation in medicine and include algorithms designed to extract information from different sources (health records, prescription patterns, family history, test results etc) to guide physicians’ decision-making processes, whether it is for treatment or better stratification of patients. The other final guidances relate to policies for low-risk digital devices for general wellness, the use of off-the-shelf software in medical devices, policy for device software functions and mobile medical apps, among other things.
Got NICE (or not) feedback on UK evidence standards framework for digital health techs?
A survey has been launched to help NICE discover stakeholders' priority areas for a second phase of work on the evidence standards framework for digital health technologies. This follows on from the first evidence standards framework for digital health technologies that NICE published in March. The evidence standards were developed with the aim of striking a balance between supporting innovation and ensuring an appropriate level of rigour and assurance for the health and care system when considering the commissioning of these types of technologies. This survey is to find out from users of the evidence standards framework what their experiences have been so far and how it can be improved. The survey is open until mid-October and can be found here: https://nice.researchfeedback.net/s.asp?k=156767307020
Zimmer Biomet bulks up dental offering with Align’s digital intraoral scanners
Align Technology, maker of the Invisalign clear dental aligners, has enlisted Zimmer Biomet to boost global sales of its iTero Element digital intraoral scanners. These devices are designed to accelerate the digital transformation of dentistry and address the limitations of analog techniques of impression-taking. Zimmer Biomet has started offering the scanners to its dental customers in select European countries and will start expanding distribution of the scanner to the US, Canada and Japan next month. The partnership is not exclusive which means Align remains free to use its own sales force (its strongest presence in North America) as well as seek other partners. The digital intraoral scanner market is competitive and fast-growing, and having a significant medtech player like Zimmer Biomet, with its broad international commercial reach, should be a boon for Align. Investors seemed happy with the deal, but Zimmer Biomet’s dental unit isn’t its strongest performer - watchful waiting might be needed to see how lucrative this partnership really is.
Medtronic unveils long-awaited soft tissue robot, Hugo
Medtronic’s long anticipated soft tissue surgical robotic system, Hugo, was unveiled to the investment community on 24 September in the company’s robotics lab in Hartford, Connecticut. Hugo is designed to address the two biggest barriers to the widespread adoption of surgical robotics: cost and utilisation. Specifically, Medtronic’s system has a modular design that allows it to be used not just for robotic surgery, but also for conventional laparoscopy and open surgery. The company also made clear that this isn’t just a one time launch but more innovations to further improve Hugo are to be expected. These innovations will not only be in the hardware but also in data analytics and advanced visualisation features, which Bob White, head of Medtronic’s Minimally Invasive Therapy Group said "were game changers." "Ultimately what a robot does is it’s better eyes, it’s better hands and a little better intelligence than the surgeon. When you can augment those through data analytics both in, before or after the surgical procedure, that would be very compelling." Medtronic had put a 2020 timeline for a CE mark submission of Hugo; entry into the US would be at least two years from now.
Diabetes data-sharing tie-ups pick up pace
Medtronic’s digital strategy also stretches to its diabetes business, where the medtech giant has partnered with the biggest insulin maker, Novo Nordisk, to make its Guardian Connect continuous glucose monitoring (CGM) system compatible with the latter's forthcoming generations of smart insulin pens. The collaboration will see dosing information from the pens integrated into the monitoring device, to allow improved management of the disease. This is Medtronic’s first partnership with an insulin company, while Novo Nordisk has already forged similar data-sharing partnerships with other CGM systems makers. These include Abbott, who is not only pairing its FreeStyle Libre glucose monitor with Novo Nordisk’s pens, but also those of Sanofi, the third largest supplier of insulin. Could a Medtronic-Sanofi diabetes tie-up also be in the books soon?
Guerbet, IBM Watson Health expand AI imaging collab into prostate cancer
Diagnostic imaging specialist Guerbet and IBM Watson Health are to co-develop and co-commercialise an AI solution to help clinicians diagnose and monitor patients with prostate cancer. The two companies are already partners in a project to develop AI diagnostic and monitoring software for liver cancer. This second tool for prostate cancer aims to detect, segment, characterise and monitor lesions over time. It will be designed for compatibility with most PACS (Picture Archiving and Communication System) visualisation systems, which will make its direct integration into the workflows of healthcare professionals that much easier.
Sanofi seeks to Happify MS patients with digital therapeutic
Sanofi has partnered with Happify Health, a specialist in digital therapies for mental well-being, to develop a prescription digital therapeutic (PDT) that will treat depression and anxiety in multiple sclerosis patients. This is the two companies' first foray into PDTs. Sanofi has exclusive rights to commercialise the resulting PDT for use in the MS patient population, after the product has undergone clinical trials and gets US FDA clearance, Chris Wasden, Happify's head of digital therapeutics, told FirstWord MedTech. While the PDT is for treating co-morbidities of MS, rather than the disease itself, it should bring added value to Sanofi’s MS franchise and help it stand its ground against increasingly fierce competition in this disease area.
Flow unveils chatbot therapist to combat depression
Staying within the area of depression, Flow has expanded its digital health offerings in this space to include a chatbot therapist. Flow launched in June a noninvasive brain stimulation headset treatment for depression for home use. This chatbot therapist aims to bridge the waiting list gap for patients seeking therapy with a consultant; the software was developed by the company to engage users with daily chat conversations and offers self-help techniques, mood tracking, curated videos, meditation and mental exercises. It helps users to learn why sleep, exercise, nutrition and meditation are the main pillars in recovering from depression - and gathers mood data to offer a personalised response modelled on behavioural therapy.
Fitbit moves into EU Afib market with FibriCheck
Fitness tracker maker Fitbit is working on narrowing the gap between it and rival Apple Watch by making a heart rhythm irregularities detection app available on its smartwatch. FibriCheck’s app is CE marked and will be available to download onto Fitbit smartwatch users in Belgium, the Netherlands, Ireland and the UK for monitoring their heart rhythm for irregularities, such as atrial fibrillation. The app uses Fitbit's commercial-grade PPG (photoplethysmography) sensors - light-based technology that measures the rate of blood flow - to capture heart rhythm measurements from a user's wrist. The measurement assessment can be viewed directly on the smartwatch screen and easily shared with medical professionals via a FibriCheck web interface to help diagnose conditions such as Afib. Apple already offers an FDA-cleared app with EEG capabilities to monitor heart rhythm and detect Afib.
Facebook doubles down on brain-computer interface investment
In a move to further build out its still-nascent brain-computer interface (BCI) pipeline, Facebook is acquiring CTRL-Labs to develop non-invasive neural interfaces based on the latter’s "intention capture" platform and apply it to the control of consumer devices. CEO of CTRL-Labs Thomas Reardon said last year during a presentation at the start-up conference Slush that the technology his company is developing is not to make digital devices like smart watches or robotic assistants or immersive virtual/augmented reality goggles smarter, but to decode the biological output of real neurons and using "digital neurons" and allow you to control physical objects through intention. The interface is via the CTRL-kit watch, that is still under development. CTRL-Labs has successfully attracted the likes of Amazon and Alphabet as investors and the company has raised around $68 million; Facebook did not specify any intention to use CTRL-Lab’s tech for medical applications, but BCI is a focus of interest for the company. It is working on a technology with the University of California San Francisco which has shown some potential for detecting intended speech in real-time from patients with neurological damage.
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