Oncology

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

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.

News We’re Watching: Medicare Payments For Renal Denervation; Acquisitions for Tempus And Boston Sci; LumiThera And Caris Land FDA Authorizations

News We’re Watching: Medicare Payments For Renal Denervation; Acquisitions for Tempus And Boston Sci; LumiThera And Caris Land FDA Authorizations

 

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 £20M UK Government-Backed Cancer Immunoprofiling Project

IMU Biosciences Joins £20M UK Government-Backed Cancer Immunoprofiling Project

 

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.

Cover Supplemental Breast Screenings, AdvaMed Urges Medicare

Cover Supplemental Breast Screenings, AdvaMed Urges Medicare

 

AdvaMed is calling on Medicare to provide coverage for supplemental screenings for women with dense breasts, an anatomical characteristic that puts them at a higher risk for cancer. The trade group says the lack of coverage for additional imaging results in many women not receiving potentially lifesaving follow-up.


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

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.

HLTH 2024: GE HealthCare’s Chief AI Officer Says Future Of AI No Longer A Black Box

HLTH 2024: GE HealthCare’s Chief AI Officer Says Future Of AI No Longer A Black Box

 
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Medtech Insight talked with GE HealthCare’s chief AI officer Parminder “Parry” Bhatia at HLTH about the firm’s new CareIntellect for Oncology offering to help clinicians make efficient use of multimodal patient data, his vision for projects within AI Innovation Lab, and the future of AI in health care.

University Of Cambridge Project Nimble Genomics Discusses Brain Cancer Liquid Biopsy

University Of Cambridge Project Nimble Genomics Discusses Brain Cancer Liquid Biopsy

 

University of Cambridge's soon-to-be spun-out Nimble Genomics is among grant-winning projects in Capital Enterprise's Cancer Tech Accelerator. Medtech Insight spoke to clinical oncologist and Nimble founder Henno Martin and co-founder Radek Lach to learn more what about the brain cancer blood test’s prospects in an increasingly competitive liquid biopsy space.

HLTH 2024: GE HealthCare Unveiled AI-Driven Platform To Quickly Provide Patient Data To Oncologists

HLTH 2024: GE HealthCare Unveiled AI-Driven Platform To Quickly Provide Patient Data To Oncologists

 
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At HLTH 2024, GE HealthCare unveiled CareIntellect for Oncology, a generative AI-driven platform to help oncologists quickly assess patient data across multiple sources to save time and improve treatment planning. The platform, currently in evaluation at two US hospitals, is set for launch in the second half of 2025.


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

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

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.

News We’re Watching: J&J Buys V-Wave, Procept Plans Aquablation Trial, TriClip Up For Medicare Coverage

News We’re Watching: J&J Buys V-Wave, Procept Plans Aquablation Trial, TriClip Up For Medicare Coverage

 

This week, J&J announced that it was buying heart failure device firm V-Wave; Procept got the FDA’s OK on a clinical trial of its Aquablation treatment for prostate cancer; and CMS began to consider Medicare reimbursement of Abbott’s TriClip tricuspid repair device.

College of American Pathologists Supports FDA’s Role In LDTs, Not Its Rule

College of American Pathologists Supports FDA’s Role In LDTs, Not Its Rule

 

The College of American Pathologists wants a US district court to scrap the FDA’s final rule that unilaterally assumes oversight of lab-developed tests, but not because the college feels the agency has no business regulating them. Helena Duncan, senior director of quality at CAP, explained the college’s position to Medtech Insight.


Some Perspectives From Medtech Industry Leaders Heard At Octane OC

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.

FDA Publishes Updated ‘Roadmap’ For Advancing Women’s Health

FDA Publishes Updated ‘Roadmap’ For Advancing Women’s Health

 

The US FDA’s Office of Women’s Health provides a research roadmap to address health concerns specific to women. The FDA recently updated the roadmap, outlining areas in which further research is needed.

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

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

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.


Owkin Teams With AstraZeneca To Develop AI-Based Breast Cancer Prescreening Tool

Owkin Teams With AstraZeneca To Develop AI-Based Breast Cancer Prescreening Tool

 

Biopharmaceutical giant AstraZeneca has partnered with start-up “unicorn” Owkin to develop an AI-powered tool to prescreen for gBRCA mutations on the basis of morphological features in digitized pathology slides. Built on extensive, high-quality data sourced from the France-based PortrAIt consortium, the AI will help to prioritize patients for further testing, streamlining the diagnostic process, Owkin says.

News We’re Watching: Neuralink’s Blindsight Gets FDA Breakthrough Device Tag; FDA Pump Recalls, Guidances; Discure, DeepLook Bolster Coffers

News We’re Watching: Neuralink’s Blindsight Gets FDA Breakthrough Device Tag; FDA Pump Recalls, Guidances; Discure, DeepLook Bolster Coffers

This week, Neuralink announced it received US FDA breakthrough device designation for a device to restore sight; medtechs Discure and DeepLook secured new funding; FDA pump recalls from B. Braun Medical and Fresenius Kabi; Axonics prevails in patent infringement lawsuit with Medtronic; Merit Medical buys Cook Medical for $210m.

Digital Tech Convergence Is Transforming Health Care - LSX Panel

Digital Tech Convergence Is Transforming Health Care - LSX Panel

 
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Leaders from Eli Lilly and Vertex Pharmaceuticals, 9amHealth, Features Capital, and accelerator PharmStars discussed the convergence of biopharma, medtech and healthtech, and what is needed to achieve health care transformation, in an LSX World Congress USA panel.

Exact Sciences Announces Early Results From Colorectal Cancer Blood Test At ESMO 2024

Exact Sciences Announces Early Results From Colorectal Cancer Blood Test At ESMO 2024

 
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Exact Sciences presented new data for its blood-based colorectal cancer screening test, which BTIG analysts say bodes well for the test’s probability to receive US FDA approval. Study results are expected in the first half of 2025.