What happened in health care technology this week – and why it’s important.
FDA releases guidance for remotely acquiring data in clinical investigations
Kat Jercich’s article in Healthcare IT News reported on the new FDA draft report that offers recommendations for stakeholders about using digital health hardware and software to gather information from remote trial participants. The draft guidance touched on regulatory considerations, noting that DHTs used in clinical investigations of medical products would usually be exempt from applicable requirements to obtain marketing authorization and other device requirements. It also outlined considerations for study sponsors when using digital health tools in this fashion.
Why it’s important – The FDA has released a handful of draft recommendations and “guiding principles” over the past year aimed at offering clarity on medical devices. Software has become an important part of many products and is integrated widely into medical devices. The FDA recognizes this evolving landscape and is seeking to provide their latest thinking on regulatory considerations for device software functions that is aligned with current standards and best practices.
Infographics of the week – The time it takes to transmit an infectious dose of COVID-19 when non-infected person is wearing different types of masks. And a great infographic from The Public Health Collaborative.
Smart sutures to monitor deep surgical wounds
As reported in The National University of Singapore News in Nature, a team of researchers led by Assistant Professor John Ho from the NUS Electrical and Computer Engineering as well as the NUS Institute for Health Innovation & Technology has invented a smart suture that is battery-free and can wirelessly sense and transmit information from deep surgical sites. The NUS team’s invention has three key components: a medical-grade silk suture that is coated with a conductive polymer to allow it to respond to wireless signals; a battery-free electronic sensor; and a wireless reader used to operate the suture from outside the body.
Why it’s important – These smart sutures incorporate a small electronic sensor that can monitor wound integrity, gastric leakage and tissue micromotions, while providing healing outcomes which are equivalent to medical-grade sutures. One advantage of these smart sutures is that their use involves minimal modification of the standard surgical procedure. The smart sutures can be read up to a depth of 50 mm, depending on the length of stitches involved. Similar to existing sutures, clips and staples, the smart sutures may be post-operatively removed by a minimally invasive surgical or endoscopic procedure when the risk of complications has passed.
World-first pig-to-human heart transplant performed in US
In a historic procedure surgeons in the US have, for the first time, transplanted a genetically modified pig heart into a living human. As reported by Rich Haridy in The New Atlas online, the patient is currently still alive, has not rejected the pig organ and is being carefully monitored at the University of Maryland Medical Center. After much consideration the US Food and Drug Administration (FDA) authorized the surgery as part of a compassionate use provision allowing for experimental treatments in patients with life-threatening conditions.
Why it’s important – Perhaps the most significant recent steps leading up to this landmark moment were advances in gene editing allowing for the development of pig organs that are not rejected by a human immune system. The genetically modified pig heart used in the transplant was supplied by regenerative medicine company Revivicor and came from a pig that had been engineered with around 10 particular genetic modifications, all focused on reducing the chances of rejection from a human immune system.
J&J partners with Microsoft to build out digital surgery portfolio
Modern Healthcare’s Jessica Kim Cohen reports that Johnson & Johnson and Microsoft have embarked on a partnership to support development of the drug and device company’s digital surgery products. Johnson & Johnson Medical Devices will collaborate with the software company to advance its digital surgery platform and internet-connected medical devices. The companies plan to apply Microsoft’s artificial intelligence, data analytics and “internet of things” capabilities to improve connectivity between Johnson & Johnson’s surgical robotics, visualization and other digital tools. The companies plan to develop digital tools that streamline surgical workflow or support surgical decision-making.
Why it’s important – Devicemakers such as Johnson & Johnson have been pursuing more digitally connected surgical tools in recent years, including AI, pre-, intra- and post-operative care and “smart” surgical implants that send data directly to physicians. And M&A is a key element of their growth moving forward, in every segment—pharmaceuticals and medical devices.
Headspace Health grabs startup Sayana to build out AI-based mental health tools
More M&A news this week as Heather Landi from Fierce Healthcare reports that six months after the $3 billion merger with Ginger, Headspace Health acquired Sayana, an AI-driven mental health and wellness company. Sayana will expand Headspace Health’s ability to provide personalized self-care content to its 100 million users. The recent merger deal combined Ginger’s teletherapy services with Headspace’s meditation and mindfulness app. Headspace Health now aims to provide an integrated experience to tackle the full spectrum of mental health needs —from prevention to clinical care—all from one platform backed by AI and data science.
Why it’s important – With the ongoing pandemic fueling demand for mental health services, this acquisition positions Headspace to capitalize on the hypergrowth in that side of the business. The company reports 59% year-over-year growth in employer bookings. According to the WHO, more than 264 million people of all ages suffered from depression in 2020. Depression is a leading cause of disability worldwide, and is a major contributor to the overall global burden of disease. The global mental health market was valued at $383.31 billion in 2020, and is estimated to reach $537.97 billion by 2030, growing at a CAGR of 3.5% from 2021 to 2030.
Researchers shatter the speed record for diagnosing rare genetic diseases with DNA sequencing
In his first article for STAT, Jonathan Wosen reviews research conducted by a team of Stanford researchers and collaborators published a letter in the New England Journal of Medicine reporting that they had sequenced 12 seriously ill patients and successfully diagnosed five of them. In all five cases, the information led to tangible changes in how patients were treated. Throughout the six-month study, which kicked off in December 2020, researchers tweaked nearly every step of the sequencing process, from having someone run samples from the hospital to the lab to shortening the time needed to prep DNA for sequencing.
Why it’s important – Typical turnaround time for diagnosis was around eight hours and as short as seven hours and eighteen minutes – less than half the current record. And the scientists are convinced they can cut that in half yet again. Such speed could be life-saving for critically ill patients. One challenge, however, insurers are moving too slowly to cover genetic sequencing, despite studies from Rady and other places showing that the health care savings from whole genome sequencing outweigh its costs.