Neo Medical Proclaims EU MDR Portfolio Success

 

After raising $68m series B funding in September, Neo Medical's announced on 2 December that its entire product portfolio has secured EU MDR approval. Co-CEO and founder Vincent Lefauconnier explained the rationale to Medtech Insight.

Boston Scientific’s Head Of Urology Says Axonics Acquisition ‘Brings A More Comprehensive Gender Balance’

 
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Medtech Insight spoke with Meghan Scanlon, president of Boston Scientific’s urology division, about integration plans for the recently acquired Axonics medtech. The purchase adds sacral neuromodulation to Boston Scientific’s portfolio, a global market that research reports valued at $1.6bn in 2023.

News We’re Watching: Schwarzenegger ZB’s Chief Movement Officer; J&J Ottava Enters Clinical Trials; Dassault, FDA Develop First Guide For Virtual Twins

 

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.

La French Touch: How France Has Built a Reputation for Excellence In Medtech

 

France’s medtech sector is strong, growing and innovative. Medtech Insight spoke to several French medtech leaders about the unique features and pitfalls their industry may face.


Advisory Panel Recommends FDA Approve Marketing Authorization For Novel Breast Cancer Treatment

 

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.

Digital Health Roundup: GE HealthCare On AI At HLTH; Medtech Conference Panel; Graphene Brain Implant; Unicorns & More

 

In this week’s Digital Health Roundup, Medtech Insight’s Marion Webb talks about her interview with GE HealthCare’s chief AI officer Parminder Bhatia about his vision for AI in health care and other highlights from HLTH. Natasha Barrow discusses her interview with Owkin on the EU AI Act and highlights Click Therapeutics’ latest clinical results.

News We’re Watching: HistoSonics Secures $90M VA Deal, CRC Blood Test Deemed Less Cost-Effectiveness, More

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.

7 Start-Ups At HLTH 2024: Shaking Up Medtech’s Business Model, ‘AI’ For Cancer Detection, MCI Assessment, Validation, Monitoring

 
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Medtech Insight was on the ground at HLTH looking for innovative companies. Learn about seven start-ups using AI to help physicians detect conditions including prostate and breast cancers, seizures and heart failure; assess patients for cognitive decline validate and deploy algorithms, and monitor patients in and out of the hospital.


News We’re Watching: Hologic Buys Gynesonics, Novocure Cancer Treatment Gets FDA Approval, New IMDRF Members

 

This week, Hologic announced it would pay $350m for uterine fibroid treatment firm Gynesonics; the US FDA authorized a Novocure cancer treatment and a surgical robot from CMR Surgical; and the IMDRF announced 15 new members.

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.

Some Perspectives From Medtech Industry Leaders Heard At Octane OC

 
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The Octane Medical Innovation Forum brought together industry experts, entrepreneurs and investors to discuss a range of topics. Medtech Insight was on the ground to bring some memorable perspectives from industry leaders.

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

 
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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

 
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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.

J&J MedTech Keeps Up Cardiovascular Momentum With Shockwave E8 Launch In US

 

Tim Schmid, executive VP and worldwide chairman of J&J MedTech, expects Shockwave, acquired in April, and Abiomed, purchased in late 2022, to be “long-term gems” for the company. Cardiovascular is among higher-growth segments where J&J has concentrated investments in recent years, along with robotic surgical systems.

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

 
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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.


‘You Can Get Paid’: Medtronic CEO On Monetizing AI

 
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Medtronic chairman and CEO Geoff Martha addressed the promise of artificial intelligence in the company’s medical technologies, AI monetization opportunities, and risk of AI overregulation in a 4 September session at the Wells Fargo Healthcare Conference.

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

 
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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.

FDA Releases Six More De Novo Summaries

 
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The US FDA released six more device classifications in early September, including products from Edwards, Interscope, and Baxter Healthcare.