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Global Regulators Home In On Regulatory Reliance, Propose Universal Framework
Regulatory reliance was the theme on Day one of the 25th Management Committee of the International Medical Device Regulators Forum in DC, with regulators from across the globe touching on the need for clarity, consistency, and trust among the world’s various regulatory bodies. The attendance for this year’s meeting was largest in the history, with some 1,200 guests representing more than 60 countries and 550 public and private sector organizations.
News We’re Watching: FDA Approves Medtronic's Affera, Roche's CGM Moves Closer To Approval, And More
Medtech Insight's News We're Watching covers medtech industry and research news you may have missed. This week, the Advanced Technologies and Treatments for Diabetes (ATTD) conference in Florence, Italy, included new results from studies of Roche's continuous glucose monitor and Medtronic's 780G insulin pump, Medtronic moved closer to earning FDA approval for its Affera ablation mapping and ablation system, and Linus Health expanded its technology for finding signs of cognitive problems in speech data.
Medtech’s Leading Revenue Earners In 2023: Johnson & Johnson Tops $30bn
Abbott’s weaker rapid diagnostic sales see the erstwhile industry leader slip down the global 2023 medtech rankings, while Johnson & Johnson passes it on the way up on the back of strong external and internal growth.
'There Is Work To Do:' Sean Salmon Discusses Medtronic's Recent Hard-Won Cardio Breakthroughs
Medtech Insight caught up with Sean Salmon, the president of Medtronic's cardiovascular business, to talk about the long-awaited FDA approval of the Symplicity Spyral renal denervation system, recent approvals of the PulseSelect pulsed field ablation system and extravascular ICD, and the company's plans for transcatheter aortic valve replacement.
News We're Watching: Tricuspid Procedure Boom, Boston Scientific Borrows $2Bn, And More
Medtech Insight's News We're Watching highlights some recent business and R&D developments you may have missed. This week, GE Healthcare and Biofourmis announced a deal to collaborate on virtual care; Cleerly touts a new CPT code for its Ischemia cardiac diagnostic software; Boston Scientific announced how it plans to pay for Axonics; a Wells Fargo survey suggests the market for transcatheter tricuspid valve repair and replacement will grow faster than previously imagined; Virtual Incision earns FDA de novo authorization for its MIRA miniaturized surgical system for colectomy procedures; and MMI and Fabric announce major financing rounds.
Change Of Plan: Medtronic Drops Ventilators, Keeps Monitoring, Forms New Unit
Medtronic will stop producing ventilators and combine the rest of its patient monitoring and respiratory interventions business into a new business called acute care and monitoring. The company had previously announced plans to divest all of the patient monitoring and respiratory intervention business.
News We're Watching: Accenture Expects 'More Human' Tech, Cardiac Genetic Tests In Walmart; And More
Medtech Insight's News We're Watching highlights a few noteworthy industry developments you might have missed: Accenture's new Vision Report addresses the future of "more human" tech in health care; Efemoral secures FDA's breakthrough status for its bioresorbable peripheral stent; Impulse Dynamics secures $135m to support its cardiac contractility modulation; PrecisionLife and Metrodora announced a partnership to address chronic diseases including long COVID; Cardio Diagnostics launches its cardiac epigenetic/genetic tests in a Walmart near Chicago.
AAOS: Study Finds Robots Do Not Help Knee Revisions; Analysts Bullish On Ortho; More
Studies presented at the American Academy of Orthopedic Surgeons' annual meeting in San Francisco found that robotics did not improve revision rates in total knee arthroplasty surgeries and chatbots do not consistently provide accurate information to orthopedics patients. Wall Street analysts came away from the meeting bullish on the joint reconstruction surgery market. More news from the 12-16 February meeting.
Abbott Moves Forward With TriClip G4 TTVR After Successful Advisory Panel
After an FDA advisory panel voted in support of Abbott’s PMA for the TriClip G4 transcatheter tricuspid valve repair device, Medtech Insight discussed the panel’s review with Barathi Sethuraman, DVP for clinical affairs for Abbott’s structural heart business.
FDA Clears AI Software Designed To Detect Early Signs Of Fatty Liver Disease
The US FDA has cleared an AI software diagnostic product from an Israeli firm designed to detect a type of fatty liver, which is often an early indication of serious liver disease.
News We're Watching: Layoffs At Illumina, Canary's Heart Sensor; SCS To Help Amputees; Samsung's Apnea Monitor
Medtech Insight's News We're Watching highlights a few medtech industry developments we are following: Illumina will lay off 111 people from its San Diego headquarters as it comes to grips with the impending Grail divestiture; a team of researchers have devised a way to use spinal cord stimulators to give amputees "feeling" in a leg that is no longer there; Samsung earns FDA de novo for sleep apnea monitor.
FDA AdCom Will Scrutinize Placebo Benefit Of Abbott’s TriClip G4 TTVR
An FDA advisory panel will discuss Abbott’s PMA for the TriClip G4 transcatheter tricuspid valve repair device on 13 February. The group’s discussion will likely focus on the lack of a clear mortality or hospitalization benefit in the TRILUMINATE pivotal trial.
Zimmer Biomet Cuts 3% Of Its Staff To Save $200m A Year
The cuts will cost up to $150m, but the orthopedics company expects to save $200m annually by the end of 2025. The company also announced plans to reduce inventories to prevent excess and obsolescence.
The Practicalities Of Working With The FDA’s eSTAR Submission Form
The FDA’s eSTAR PDF is supposed to standardize premarket submissions, but is it really easier for regulatory specialists?
Updated: J&J Moves Closer To PFA Approval; New Data Presented At Boston AF
The AF Symposium in Boston Featured presentations of two trials of Johnson & Johnson/Biosense Webster’s Varipulse pulsed field ablation system and more safety data from the ADVENT trial of Boston Scientific’s Farapulse PFA.
Cardio Catch-Up: Boston Scientific Pushes US TAVR Timeline Again
Boston Scientific's plan to launch the Acurate neo2 TAVR system in the US this year depended on earning an FDA approval based on interim results from the ACURATE IDE trial. The company is optimistic the full data set will support approval after they are announced later this year.
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