Search Tag: Medical Device
2025 08 Apr
The EU Medical Device Regulation (MDR 745/2017) was introduced to improve safety and support innovation in the European medical device sector. However, since its implementation, unintended consequences have emerged, particularly affecting patient access and innovation. The European Society of Cardiology (ESC) has raised significant concerns about...Read more
2023 25 May
The acquisition offers access to a unique solution on the market which completely cleans dental implants with peri-implantitis, setting ideal conditions for successful healing The device will be accessible for the European market by the end of June 2023 The GalvoSurge device is compatible with most dental implant systems Straumann announces...Read more
2023 22 May
The quickly evolving major presence of Artificial Intelligence in healthcare means the current regulatory landscape is changing. AI-based medical devices are rapidly revolutionising the industry across the globe, but along with the many positive developments made in healthcare delivery, calls for more regulatory oversight are growing. Many countries...Read more
2023 22 May
Effective regulatory systems are an essential component of health system strengthening and contribute to better public health outcomes, even more so in the age of medical devices that are enabled by machine learning. Key Points Without medical devices, many critical healthcare procedures would not be possible. WHO provides guidance...Read more
2022 01 Dec
NeoDynamics AB, a medical device company dedicated to advancing the diagnosis and care of cancer, announced the appointment of current board member Matt Colpoys as head of the company’s US subsidiary. Colpoys will remain on the board and will report to CEO Anna Eriksrud. “Matt is an experienced executive with an extensive background in new product...Read more
2022 12 Oct
Vivera is pleased to welcome Dr. Geetha Rao to the Company’s Advisory Board as its Regulatory Advisor. Dr. Rao will guide Vivera through its regulatory pathway for its medical device and technology products, ZICOH and MDZone . Dr. Rao is an entrepreneur, executive, and strategic advisor on medical devices, health information technology,...Read more
2022 15 Aug
Edward Shadek, Jr. , former deputy chief of Investments at Putnam, brings wealth of financial acumen as company prepares for clinical trials Leucadia Therapeutics, a company working to cure Alzheimer's disease with a medical device implanted by minimally invasive surgery, has hired a chief financial officer with deep investment management experience...Read more
2022 06 Jun
Experienced technology-driven innovator aims to position and accelerate the company's first-of-its - kind surgical technology platform Medcura, Inc., a commercial-stage life science and medical device company, has appointed James (Jim) Buck as Chief Executive Officer (CEO). A globally connected leader, Buck has been serving as Director...Read more
2022 10 Mar
Magnus Medical, Inc., a medical device company developing a novel, rapid-acting brain stimulation technology designed to treat adults suffering from neuropsychiatric disorders has announced the appointment of three executives to key positions on the leadership team. Erica Lundmark joins as vice president of hardware engineering, Tammy Morton joins...Read more
2022 18 Jan
Foldax®, Inc. has announced the appointment of medical device veteran Scott Huennekens as an independent member of the company’s board of directors. Huennekens possesses more than 30 years of experience in the medical device industry, leading high-profile companies through IPOs and acquisitions, and serving on the board of directors for several innovative...Read more
2020 17 Mar
Digital healthcare aims to improve delivery of care and outcomes for patients. However, an upward trend in healthcare cyber attacks has raised concerns about the use of IoT medical devices and patient safety. The technologically fragmented IoT infrastructure, as noted by infosec experts, is a major factor behind the increasing number of attacks....Read more
2020 17 Mar
Digital healthcare aims to improve delivery of care and outcomes for patients. However, an upward trend in healthcare cyber attacks has raised concerns about the use of IoT medical devices and patient safety. The technologically fragmented IoT infrastructure, as noted by infosec experts, is a major factor behind the increasing number of attacks....Read more
2020 16 Jan
Swiss hospitals have announced successful processing on a trial of medical device orders via the Blockchain. The Cantonal Hospital Winterthur, the Cantonal Hospital Baden, the University Children's Hospital Zurich and the Spitalregion Fürstenland Toggenburg along with two medical device suppliers Anandic System Medical and ITRIS Medical undertook...Read more
2019 07 Jun
The Patient Safety Movement Foundation (PSMF) announced today that the global medical device developer and manufacturer Mindray has become the 90th company to sign the PSMF’s Open Data Pledge, demonstrating its commitment to improving patient safety through data sharing. “We are excited to have Mindray join the Patient Safety Movement,” said...Read more
2019 26 Mar
The U.S. Food and Drug Administration (FDA) recently released its draft guidance on managing cybersecurity in medical device premarket submissions. In the draft, a two-tiered system for identifying cyber risk is proposed, with higher risk devices falling into Tier 1 while other devices would be of “Standard Cybersecurity Risk” or Tier 2....Read more
2019 15 Jan
Technology keeps advancing rapidly that manufacturers of medical devices are always on the lookout for tech developers who can help them to improve their products and boost revenues. These kind of alliances between medical device companies and tech partners, experts say, actually began some five years ago. One of the more notable collaborations...Read more
2017 06 Dec
EOS imaging, the pioneer of 2D/3D imaging and data solutions for orthopedics, today announced the Galien Foundation has awarded it the Prix Galien in the Medical Device category. The award is presented to EOS imaging in recognition of its EOS system for 2D/3D low dose imaging and associated EOSapps suite of online 3D surgical planning solutions...Read more
2017 07 Nov
In today's interconnected environment, protecting healthcare IT systems against malware attacks seems to be an uphill task for infosec professionals. The recent spate of ransomware attacks (e.g., WannaCry) has made many infosec teams to be more aware of cybersecurity issues associated with the Internet of Things (IoT). But some IT experts see some...Read more
2017 19 Sep
A new initiative that will improve medical device security and facilitate sharing of best practice is being rolled out internationally this year. The Medical Device Innovation, Safety and Security Consortium (MDISS ) has launched the first of what are planned to be more than a dozen international medical device security testing labs and cyber-ranges....Read more
2017 12 Sep
These days the use of many medical devices requires them to connect or interact with other devices or IT systems. That's why the U.S. Food and Drug Administration wants device manufacturers to make safe connectivity a central part of their design process. Manufacturers need to provide a "reasonable assurance of safety and effectiveness" for their interoperable...Read more
2017 28 Feb
As adoption of Internet of Things (IoT) technology increases, there's growing concern about the security and safety of networked medical devices. A U.S. Department of Homeland Security official has warned that medical devices are increasingly targeted by ransomware attacks. When it comes to “ransomware moving into the embedded device” area, it’s...Read more
2016 25 Aug
WHEN WILL YOUR PACEMAKER BE HACKED ? In 2013, the Washington Post (among other news outlets) reported that Vice President Dick Cheney’s cardiac pacemaker had its wireless capabilities disabled when implanted in 2007 to eliminate any potential cyberintrusion threat (Peterson, 2013). This old headline, with the more recent U.S. Food and Drug...Read more