Device Area

This week, renal denervation systems from Medtronic and Recor won Medicare coverage; Boston Scientific bought cardiac-mapping firm Cortex; Veravas and Phanes Biotech teamed up on an Alzheimer’s diagnostic; and more.

Patients treated with Abbott’s Esprit BTK system had better results and fewer repeat procedures after two years than a control group, the company announced this week. Abbott vascular leader Jennifer Jones-McMeans spoke with Medtech Insight about what the results could mean for patient care.

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.

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.

The US FDA has published draft guidance for predetermined change control plans for medical devices along with recommendations for sponsors including them in marketing submissions to the agency.

The document explains how user fees for combination products are assessed and administered, as well as waiver possibilities.

The US Federal Trade Commission wants to clean up the FDA’s Orange Book by purging medical device patents that the commission says should not be in the listing. The FTC argues improper patents in the Orange Book block lower-cost generic equivalents from coming to market. Medtech Insight spoke to attorney Sara Koblitz about the FTC’s delisting push.

The company has taken the ambitious approach of establishing a manufacturing base capable of producing millions of devices before any attempt at a regulatory submission.

Beta Bionics’ automated insulin delivery system is now pairable with Abbott’s FreeStyle Libre 3 Plus CGM.

In her inaugural address to the medtech industry during the Medtech Conference, acting US CDRH director Michelle Tarver described her mission-driven approach.

This week, two device testing labs in China landed FDA warning letters; refunds for 1Health.io clients; FDA AR/VR product list expands. 

Octave Bioscience’s CEO Doug Biehn sat down with Medtech Insight at HTLH to talk about the company’s plans for expanding their multivariate biomarker blood test for MS analysis and development of a diagnostic for Parkinson’s disease.

This week, renal denervation systems from Medtronic and Recor won Medicare coverage; Boston Scientific bought cardiac-mapping firm Cortex; Veravas and Phanes Biotech teamed up on an Alzheimer’s diagnostic; and more.

IMU Biosciences joins a UK consortium of 27 academic and industry partners to undertake “immunoprofiling” of 6,000 cancer patients to assess their response to treatment.

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.

Genetic Analysis CEO Ronny Hermansen and Christina Casén, senior VP of clinical and medical affairs, discuss the company’s polymerase chain reaction (PCR)-based approach to gut microbiota profiling versus DNA sequencing, competitive landscape, and opportunities for supporting pharma R&D and assessing drug treatment success.

Announced in conjunction with a $97m Series D financing round, Neptune underscores its gastrointestinal focus and robotics aspirations by spinning out Jupiter Endovascular, which will leverage $21m of the funding to support ongoing development of its Endoportal Control technology.

A survey of over 1,000 patients worldwide found that the majority of patients agree that hospitals and endoscopists are responsible for mistakes made by devices that use AI.

In 2024, Visana Health will leverage $10.1m in seed funding to expand its holistic, value-based virtual clinic to add conditions that differently or disproportionally affect women and provide at-home testing. Health plans and employers are taking notice, and Visana’s CEO expects further investment to follow.

Octave Bioscience’s CEO Doug Biehn sat down with Medtech Insight at HTLH to talk about the company’s plans for expanding their multivariate biomarker blood test for MS analysis and development of a diagnostic for Parkinson’s disease.

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.

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.

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.