software as a medical device (SaMD) Archives

Avail Medsystems plans to roll out first third-party software integration

The Avail Medsystems console brings remote experts into the operating room virtually. [Photo courtesy of Avail Medsystems]

Avail Medsystems is testing a third-party software integration that it plans to launch in the coming months.

Avail executives said they hope it will be the first of many partnerships with medical technology developers of software or algorithms that could be useful in the operating room.

Avail CEO Daniel Hawkins expects to launch the software integration in the first quarter of 2023, he told Medical Design & Outsourcing after a panel discussion at DeviceTalks West in Santa Clara, California. He declined to name his company’s partner, but offered some details as the product goes through UI and customer experience testing.

“A remote user can pull up that software and optimize the workflow in a specialty category that really benefits from workflow enhancement,̶…

Avail Medsystems plans to roll out first third-party software integration

The Avail Medsystems console brings remote experts into the operating room virtually. [Photo courtesy of Avail Medsystems]

Avail Medsystems is testing a third-party software integration that it plans to launch in the coming months.

Avail executives said they hope it will be the first of many partnerships with medical technology developers of software or algorithms that could be useful in the operating room.

Avail CEO Daniel Hawkins expects to launch the software integration in the first quarter of 2023, he told Medical Design & Outsourcing after a panel discussion at DeviceTalks West in Santa Clara, California. He declined to name his company’s partner, but offered some details as the product goes through UI and customer experience testing.

“A remote user can pull up that software and optimize the workflow in a specialty category that really benefits from workflow enhancement,̶…

Mayo Clinic develops AI childbirth risk prediction tool for women in labor

Dr. Abimbola Famuyide is a Mayo Clinic OB-GYN studying AI algorithms for childbirth. [Photo courtesy of Mayo Clinic]

Mayo Clinic researchers are using AI algorithms to calculate childbirth risk while women are in labor in an effort to reduce the rate of cesarean delivery and complications.

The machine learning algorithms — a type of device known as Software as a Medical Device (SaMD), where the software is the device rather than a mechanical device — analyze patterns of changes for women in labor.

ADVICE: How to pass the patent eligibility test for Software as a Medical Device

“This is the first step to using algorithms in providing powerful guidance to physicians and midwives as they make critical decisions during the labor process,” senior author Dr. Abimbola Famuyide said in a news release. “Once validated with further research, we believe the algorithm will work in real time,…

How to pass the patent eligibility test for Software as a Medical Device

Kathleen Daley is a partner at Finnegan, Henderson, Farabow, Garrett & Dunner. [Photo courtesy of Finnegan]

There’s “significantly more” to it than a good idea for an SaMD algorithm.

Kathleen Daley, Angeline Premraj and Jason Zhang, Finnegan

Technology continues to change the practice of healthcare, and one area where this has become evident is the increasing prevalence of software aimed at healthcare applications. This can include software that is integral to a medical device, software used in the manufacture or maintenance of a medical device, or software that is itself the medical device, also known as Software as a Medical Device (SaMD).

SaMD is an area of tremendous growth in the medical healthcare field. However, there is still significant unpredictability in the patent eligibility of SaMDs. This article provides an overview of the challenges facing the patent eligibility of SaMDs and…

Software as a medical device: Here’s how the regulatory landscape is changing

When it comes to software as a medical device, the regulatory landscape is quite complex.

Nach Davé, Premier Research

[Image from Pixabay]

Software as a medical device (SaMD) has emerged as a class of devices for collecting, processing and analyzing healthcare data to manage disease. Powered by analytics, SaMD accelerates the diagnosis and treatment of a wide range of medical conditions and is automating certain aspects of patient care, saving time and improving health outcomes. Because the technology is relatively new, however, the regulatory environment is still evolving as regulators scramble to keep pace with innovation.

Health providers are increasingly deploying SaMDs to facilitate patients’ pain management, arrhythmia management, and blood glucose monitoring. Some applications require daily use by the patient — sometimes multiple times a day — while remaining compliant with good clin…