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Surgical Procedures

Replace Or Repair? Cardiologist, TriCares CEO On Changes In Tricuspid Valve Intervention

Tricuspid valve innovation has taken off since the US FDA’s 2023 authorizations of Edwards' Evoque and Abbott's TriClip systems. Whether to repair or replace tricuspid valves remains an open, nuanced question among cardiologists. Dr. Henrik Treede of University Hospital Mainz and TriCares CEO Ahmed Elmouelhi offer views on the evolving space.

Combating Stroke Requires Global Health Systems To Take A Giant Step

Health authorities around the world are being advised to mitigate the relentless rise in the long-term costs of stroke, set to top $1.5tn within a generation. Wider availability of mechanical thrombectomy will help address providers’ and patients’ needs, Royal Philips CMO Carla Perón explained in an interview with In Vivo.

News We’re Watching: New FDA Approvals For Breast Implant, Colon Cancer Test, Imaging Agent; TAP Expansion, AI Standards

This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.  

Inbrain Has Sights On Parkinson’s Following First-In-Human Test Of Graphene-Based Implant

Spain-based Inbrain Neuroelectronics plans first-in-human study to show safety of its graphene-based technology in direct contact with human brain while also developing a second interface for treating Parkinson’s disease.

Synchron Announces Positive Results From Stentrode BCI Study, Plans For Pivotal Study

After announcing positive results showing that its Stentrode BCI is safe in six patients, brain-computer interface company Synchron is planning a pivotal trial to eventually file for FDA approval.

Angiodynamics Initiates Thrombectomy Trial In Europe After Showing Positive Trial Results in US

According to Zacks Equity Research, the new trial seeks to support AlphaVac’s adoption in the European market, where pulmonary embolism prevalence and severity is an estimated 435,000 events annually.

LSX Medtech Panelists Talk AI, Market Access Strategies, Digital Therapeutics Reimbursement

Highlights from Medtech Insight's on-the-ground coverage of LSX in Boston. 

‘Catastrophic’ Risk Linked To Smiths Medical Trach Tubes

Smiths Medical has recalled scores of Bivona tracheostomy tubes due to a manufacturing defect that can result in disastrous consequences. The company reports multiple injuries, and one death, linked to the devices.

Focus On Cardio-Oncology, Clinical Trends And AI At ESC 2024

Cardio-oncology and cardiotoxicity have come directly into the spotlight following ESC's first consensus guidelines. AI is being used for early risk identification, Philips said during the European Society of Cardiology congress 2024.

News We’re Watching: $1B Judgement Against J&J Recalls For Abbott, Baxter, More; Karl Storz Announces Fujifilm Partnership

This week, a Delaware court awarded Auris Health shareholders $1bn in a lawsuit against Johnson & Johnson; Abbott recalled some FreeStyle Libre 3 sensors; and McKesson purchased a controlling interest in a Florida cancer care chain.