As companies increasingly use artificial intelligence (AI) in medical devices and applications to help treat and diagnose patients, innovators must be careful of excluding large sections of the population in their algorithms and in their data gathering process, delegates heard at the Medtech Futures conference in Cambridge, U.K.
Europe has given device makers more time to meet requirements set out in the 2017 Medical Devices Regulation (MDR). The European Parliament approved in mid-February an extension of the transition periods for medical device and IVD manufacturers to comply with the new rules, which aim to enhance safety for patients and ensure the “smooth functioning of the internal market.”
Visionhealth GmbH will use the €3 million (US$3.2 million) it recently raised in a pre-series A financing to conduct a clinical trial on its digital health app designed to provide more accurate dosing of treatments for chronic obstructive pulmonary disease (COPD) and asthma.
The European Health Data Space (EHDS) proposal is designed to standardize practices for transmission and other sharing of health information, but this proposal is far from the only significant development coming out of Brussels.
While still pending clearance in the U.S., Medtronic plc’s Minimed 780G advanced hybrid closed loop (AHCL) system continues to post strong results in clinical trials. Results of two studies presented at the 2023 Advanced Technologies & Treatments for Diabetes Conference in Berlin on Feb. 27 demonstrated that patients with type 1 diabetes (T1D) who used the device for one year maintained a 26.7% increase in time in range for adults and a 14% increase in time in range for children aged 7 to 17 compared to their baseline using multiple daily injections with a continuous glucose monitor (CGM).
Medtronic plc recently received the CE mark for its Aurora extravascular implantable cardioverter-defibrillator (EV-ICD) strengthening its cardiovascular portfolio which saw a 7% year-on-year growth in the third quarter of its fiscal year 2023.
More than two months after a voluntary recall by Zimmer Biomet Holdings Inc. (ZBio), the U.K. Medicines and Healthcare products Agency (MHRA) issued an alert confirming the U.K. National Joint Registry has identified that there are higher revision rates for certain of the company’s total knee replacement prostheses, as compared to all other knee replacements in the registry.
Previa Medical SA will begin clinical trials later this year of its artificial intelligence software designed for early detection of sepsis after it raised €2.1 million (US $2.2 million) in seed funds.
Royal Philips NV released a grim annual report for 2022 that showed a little willingness to share the pain of an unabashedly awful year for the health tech company, which has been plagued by a recall fiasco that has bled into multiple years. Shareholders lost much of their investment with the company’s more than 60% drop in market value in 2022, 10,000 employees faced job loss and all current members of top management waived their annual incentive payouts. Notably, former CEO Frans van Houten, who was replaced in October and oversaw the ill-fated recall, did not waive his bonus of $208,370.
To restore hearing function in patients with hearing loss or deafness, cochlear implantation is seen as the only method that works, but insertion of the electrode array may cause direct mechanical injury to the cochlea, with the subsequent loss attributed to an inflammatory response driven by proinflammatory cytokines, reactive oxygen species and apoptotic signals.
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