Oncology

Exact Sciences: Lower Guidance, But Payer Care Gap Programs Plan Shows Promise

 

Exact Sciences lowered its full-year 2024 midpoint guidance by $90m. Commercial adjustments to the sales force are being made "to fix the basics," senior company executives told the Jefferies London Healthcare Conference.

Guardant Health Eyes Earlier Breakeven As Liquid Biopsy Boosts Outlook

 

Guardant Health expects to break even by 2028. A positive pricing outlook for the Guardant 360 lab test could bring this forward by maybe one year, CFO Mike Bell told the Jefferies London Healthcare Conference.

News We’re Watching: FDA Recalls Communication Pilot; Cardinal Buys Two Firms; Medtronic Diabetes App Cleared

This week, the US device center announced a pilot program to speed communications about high-risk recalls; Cardinal paid $3.9B for Advanced Diabetes Supply Group and GIA Alliance; a companion diagnostic for Merck lung cancer drug Tepmetko got FDA clearance; and more.

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.


Harbinger Health Enters New Collaboration With MSK On Validation Trials, Presents New Data

 
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Massachusetts-based Harbinger Health has partnered with Memorial Sloan Kettering Cancer Center in New York to accelerate the validation of its AI-driven blood test for early-stage cancer detection. The company also recently presented encouraging data at two conferences.

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

 

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 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

 

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

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

 
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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'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

 
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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

 
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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.

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

 

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

 
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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

 

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

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.