Posted to its website, the FDA’s list of AI/ML-enabled medical devices provides detailed submission information on nearly 350 separate medical devices that have been reviewed and authorized by the agency under its 510(k), De Novo, or PMA routes.
AI/ML-enabled medical devices have the potential to generate significant amounts of healthcare data, which can be used by healthcare providers and researchers to improve the delivery of healthcare and improve patient outcomes. The FDA says that its release of the list of authorized devices provides both industry and the general public with important information on innovations and developments in this growing segment of the medical device industry.
The UK’s Medicines and Healthcare products Regulatory Agency detailed its plans in a recently released Guidance, “Software and AI as a Medical Device Change Programme.” The Guidance maps out 11 different “work packages” that would implement changes across the entire medical device lifecycle, from initial product qualification to post-market surveillance.
The Guidance work packages also address issues specific to AI-enabled medical devices, including cybersecurity issues, mobile health and applications, alternative approval routes for innovative technologies, and the interpretability of AI data.
According to an investigation conducted by WebsitePlanet and independent security researchers, the breached records contained user data that include user names, date of birth, key physical characteristics such as height, weight, and gender, and geographic location. A sampling of the breached records indicates that Apple’s Healthkit application represented the original source of the majority of the records.
WebsitePlanet’s investigation traced the breach to GetHealth, a company that accesses and synchronizes health and wellness data from wearables, medical devices, and other medical applications. GetHealth has reportedly confirmed that the affected data has been secured subsequent to the original breach.
Under a formal proposal, the Commission is seeking to amend EU Directive 2014/53/EU (also known as the Radio Equipment Directive, or RED) to harmonize charging technologies by standardizing the use of USB-C charging ports. The proposal would also harmonize supported speeds of charging devices and unbundle the sale of chargers from the sale of electronic devices.
The Commission’s move is reportedly part of its overall effort to reduce consumer inconvenience and electronic waste created by the use of different and incompatible charging technologies for electronic devices. The Commission estimates that the average consumer owns three mobile phone chargers to ensure reliable access to compatible charging technologies, and that disposed chargers constitute 11,000 metric tons of e-waste every year.
The Commission’s proposal must now be adopted by the European Parliament and the Council. Assuming that the proposal is accepted, it is expected that manufacturers will have a transition period of 24 months to take the steps necessary to comply with the amended RED requirements.
Born near London in 1940 into a family of engineers, Sinclair is credited with creating the world’s first electronic calculator in 1972. His first mass-market home computer, the Sinclair Model ZX80, was released in 1980 in the United Kingdom (his home country), and sold for just under £80 in kit form, and for less than £100 fully built. The ZX80 and its successor model the ZX81 quickly ranked among the best-selling home computer models in the UK and the U.S.
Later in his career, Sinclair also actively explored the development of other advanced electrical and electronic technologies, including smartwatches and battery electric vehicles, and even a folding bicycle intended for commuters.
Sinclair was knighted by Queen Elizabeth in 1983 and was made a fellow by the Imperial College of London in 1984. He was 81 years old at the time of his death.
According to a press release posted to the UK Government website, the 10-week public consultation seeks views from the medical device and healthcare industries, including medical practitioners, patients, and the wider public. The consultation is intended to cover a broad range of regulatory issues, including requirements for conducting clinical investigations, assessing medical device safety, importer and distributor responsibilities, and post-market surveillance activities.
The MHRA says that the public consultation on the UK’s medical device regulatory framework has been launched in the wake of the UK’s departure from the European Union, and the opportunity to create a “world-leading regime” that supports medical device innovation, streamlines the device approval process, and prioritizes patient safety.
According to Commission Implementing Decision (EU) 2021/1182, five additional standards can now be used to demonstrate compliance with applicable requirements of the EU’s Medical Device Regulation, (EU) 2017/745. These are:
- EN ISO 10993-23:2021, the standard for “Biological evaluation of medical devices – Part 23: Tests for irritation”
- EN ISO 11135:2014 and EN ISO 11135:2014/A1:2019, the amended standard for “Sterilization of health care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices”
- EN ISO 11137-1:2015 and EN ISO 11137-1:2015/A2:2019, the amended standard for “Sterilization of healthcare products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices”
- EN ISO 11737-2:2020, the standard for “Sterilization of health care products – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process”
- EN ISO 25424:2019, the standard for “Sterilization of health care products – Low temperature steam and formaldehyde – Requirements for development, validation and routine control of a sterilization process for medical devices.”
According to an article posted on the NIST website, the new model reduces the number of measurements needed to determine the most reliable wireless configurations. Under testing, the use of the model results in a significant reduction in the number of required measurements, potentially by as much as 33%.
NIST says that the model was developed specifically for two-way coexistent testing, which is intended to evaluate two separate wireless systems under various transmission scenarios to identify the configurations that allow both systems to meet essential performance requirements. The model uses a sequential series of experiments that select a transmission configuration based on a limited set of previously collected coexistence data.
The NIST spectrum sharing model should be useful for testing up to 10 devices operating simultaneously. And NIST researchers are reportedly using machine learning and artificial intelligence (AI) technologies to investigate other spectrum sharing modeling techniques.
Standards Council of Canada to Develop National Standards Strategy
According to a recent press release, the SCC’s National Standards Strategy (NSS) is intended to help the SCC and its stakeholders ensure that efforts to improve Canada’s system of standardization are strategic, focused, and deliberate. The Strategy is also expected to help clarify Canada’s standardization priorities in the international standards-setting process.
The National Standards Advisory Committee will spearhead the NSS consultation effort and is comprised of representatives from the SCC and other standards development organizations, government, and industry. The development of the NSS is scheduled to commence in the Fall and is expected to take about 10 months to complete. The process will also include opportunities for public input to ensure transparency in the deliberative process and that the final product reflects a wide range of perspectives.
According to Chantal Guay, CEO of the SCC, the NSS “will create unparalleled opportunities to boost Canada’s economic competitiveness, drive innovation, and enhance health and safety across sectors.”
This year’s Ig Nobel Prize award winners include:
- For biology, a team of researchers from Sweden and Ireland for their investigation into the variations in purring, meowing, squeaking, hissing, and growling in cat-human communications;
- For ecology, researchers from Spain and Iran for using genetic analysis to identify different species of bacteria found in wads of discarded chewing gum stuck on pavements in various countries;
- For chemistry, a team from Germany, the UK, New Zealand, Greece, Cyprus, and Austria for their efforts to determine the connection between odors found in airborne samples taken in movie theatres and the levels of violence, sex, drug use, and antisocial behaviors in the movie being watched;
- For transportation, researchers from the U.S., South Africa, and Namibia for their investigation of the safety of the airborne transportation of rhinoceros in an upside-down position (!!!); and, finally
- For economics, researchers from France, Switzerland, Australia, Austria, the UK, and the Czech Republic for research that found a potential correlation between the obesity of a country’s politicians and the extent of that country’s corruption.