Surgical Procedures
This week, Zimmer Biomet announced a new role of chief movement officer for Arnold Schwarzenegger, J&J MedTech receives IDE approval for Ottava, Dassault Systèmes with US FDA develop first guide for virtual twins, Mainz Biomed and Thermo Fisher team up to fight colorectal cancer.
The US FDA’s advisory panel on general and plastic surgery devices voted in favor of agency approval for a novel medical device for treating early stage, low-risk breast cancer as a potential alternative to lumpectomy. The agency is expected to make its decision on the device early next year.
This week, HistoSonics announced it will bring its ultrasound system for destroying liver tumors into VA hospitals, Edwards Lifesciences reports encouraging TRISCEND II trial results at TCT, study finds blood test for CRC screening are less cost-effective than alternatives, and more.
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.
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.
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.
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.
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.
Highlights from Medtech Insight's on-the-ground coverage of LSX in Boston.
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.
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.
Renata Medical has received US FDA clearance for its Minima Growth stent, which is designed for neonates, infants and young children and built to expand as the patient ages.
Inari Medical is updating use instructions for a clot-removing catheter due to the potential for serious adverse effects, including death.
This week, a medical group sued the FDA to block a lab-developed test rule; the FDA published guidance on device classifications; Defibtec issued a recall of its chest compression device and ICU Medical updated instructions for its infusion pump batteries; Maui Imaging raised a $4m DOD grant to put imaging tech into military-based trauma units.
Getinge says it plans to pay about $477m for organ transport and services company Paragonix Technologies in an effort to “redefine the market standard in transplantation.”
J&J buys heart failure implant company V-Wave, whose Ventura Interatrial Shunt could be the first device of its kind aimed to reach the roughly 800,000 patients in the US who experience heart failure and reduce ejection fraction every year.
Caresyntax said it will use the $180m it recently raised in a series C extension and debt financing round to build out its vendor-neutral surgery platform aimed to help surgeons with real-time and long-term decision support to improve patient outcomes and efficiencies.
Medtronic receives US FDA approval for deep brain stimulation surgery for people with Parkinson’s and essential tremors while the patient is under general anesthesia, making it the first and only company to offer DBS surgery while the patient is asleep.
This week, Medtronic recalled a nerve monitoring system due to reports of false responses. The US FDA approved the first auto-injector for opioid-overdose, made by Purdue Pharma. The agency granted de novo authorization for Labcorp’s PGDx elio plasma focus Dx used by labs for genetic profiling. As of 7 August, 950 AI/ML devices have been approved by the FDA. EKO Health teamed up with LSU to help detect arrhythmias and murmurs in student-athletes.
J&J Medtech announced the FDA clearance of its dual-use robotics platform Velys Spine with plans to go to market in the first half of 2025.