The increasing menace to healthcare data security
GlobalData is predicting the global cybercrime market will reach $10.5tn annually by 2025. Credit: ImageFlow via Shutterstock. In a concerning trend that has sent shockwaves through the healthcare industry, the number of patient records exposed in data breaches doubled in 2023, highlighting a significant and growing threat to healthcare data security. This alarming surge in […]
Roche and PathAI partner to develop AI-powered companion diagnostics
Roche plans to deploy the algorithms developed by PathAIto its navify Digital Pathology solution. Image Credit: Michael Vi / Shutterstock. Roche has partnered with PathAI to leverage artificial intelligence (AI) to develop algorithms for companion diagnostics. PathAI will exclusively work with Roche Tissue Diagnostics (RTD) for an undisclosed pre-specified time to develop AI-enabled digital pathology […]
Sana strives for breakthrough designation as VR PTSD trial concludes
The global VR market is forecast to reach $51bn in 2030, according to GlobalData. Caption: selimaksan via Getty Images. US-based device company Sana Health is seeking breakthrough device designation from the US Food and Drug Administration (FDA) following the completion of a decentralised trial (DCT) from virtual contract research organisation (VCRO) Curavit Clinical Research, for […]
Mainstay Medical’s ReActiv8 MRI labelling secures FDA approval
The device is designed to alleviate intractable chronic low back pain in adults. Credit: JARIRIYAWAT / shutterstock.com. Mainstay Medical has received approval from the US Food and Drug Administration (FDA) for full-body MRI conditional labelling for its ReActiv8 Restorative Neurostimulation system. The approval allows all current and future US patients implanted with the device, featuring […]
Macmillan cancer charity invests £350,000 in AI-powered cancer tool
Lucida Medical’s Pi software uses an AI that has been trained to identify signs of prostate cancer taken from MRI scans. Credit: Shutterstock / Image Point Fr. UK charity Macmillan Cancer Support has invested £350,000 ($442,000) into an artificial intelligence (AI) powered software designed to help expedite the diagnosis of prostate cancer. The investment into […]
Canary Medical completes cardiac sensor device trial
The trial confirmed the sensor’s ability to detect mitral regurgitation sound signals. Credit: Zay Nyi Nyi/shutterstock.com. Canary Medical has completed the first-in-human clinical trial of its Cardiac Auscultation monitoring sensor device. The new implantable sensor is aimed at enhancing the management of congestive heart failure symptoms. Conducted in Paraguay, the limited feasibility trial has demonstrated […]
US FDA clears Tyber Medical’s Tibia Plating System
Tyber’s Poximal Tibia Plating System. Credit: PRNewswire/Tyber Medical LLC. Tyber Medical, a provider of private-label orthopaedic implants, has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Proximal Tibia Plating System. Designed for both complete articular and partial articular fractures, the system aims to stabilise bone fragments and promote efficient healing […]
Sensome begins Clotild Smart Guidewire trial for PAD treatment
Sensome anticipates preliminary results from the trial by mid-2024. Credit: Cavan-Images/shutterstock.com. Sensome has commenced the SEPARATE clinical trial to evaluate its Clotild Smart Guidewire technology in detecting blood vessel blockages in patients with peripheral artery disease (PAD). The Clotild device, which received breakthrough designation from the US Food and Drug Administration (FDA) for brain artery […]
internet of things related private equity activity in the medical devices industry
In value terms, internet of things-related deal activity decreased by 98% in Q4 2023 compared with the previous quarter’s total of $2.8bn. Related deal volume decreased by 33% in Q4 2023 versus the previous quarter. The top-ranked legal advisors supporting these private equity deals in Q4 2023 were Allen & Overy; Davis Polk & Wardwell; […]
electronic medical record (emr) systems related M&A activity in the medical devices industry
In value terms, electronic medical record (emr) systems-related deal activity remained flat in Q4 2023 compared with the previous quarter and as compared to Q4 2022. Related deal volume increased by 67% in Q4 2023 versus the previous quarter and was 25% higher than in Q4 2022. The top-ranked financial advisors supporting these M&A deals […]