FDA clears EhmetDX ’ s 3D CBCT positioning software

Early stage medical equipment developer EhmetDX said late last week that it won FDA 510(k) clearance for its 3D CBCT positioning software. The Plymouth, Mich.-based company said that the newly cleared system is designed to guide the position of proton beams in patient treatments. The system is slated to be used in patient treatment at the McLaren Proton Therapy Center beginning this month, EhmetDx said. “We look forward toward patient treatment using our software for positioning now that the FDA concluded that our X-ray positioning system has met the requirements needed for 510(k).  With patient treatment imminent, our team will turn its efforts to focus on commercialization of the Mammoknife: the world’s first self-shielded, linac-based breast cancer radiotherapy device that will raise the standard of treatment for women globally,” founder &CEO Michael Teicher said in a press release. The post FDA clears EhmetDX’s 3D CBCT positioning software appeared first on MassDevice.
Source: Mass Device - Category: Medical Devices Authors: Tags: Food & Drug Administration (FDA) Regulatory/Compliance ehmetdx Source Type: news

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ConclusionsInstitution of a BP biologic dose constraint may reduce brachial plexopathy risk without compromising target coverage. MCBD plan evaluation provides valuable information to physicians that may assist in making clinical judgments regarding relative priority of target coverage versus normal tissue sparing.
Source: Practical Radiation Oncology - Category: Cancer & Oncology Source Type: research
In conclusion, this numerical study suggests that the ionoacoustic wave field may well be used to monitor the proton dose distribution during breast cancer treatment. PMID: 31600743 [PubMed - as supplied by publisher]
Source: Physics in Medicine and Biology - Category: Physics Authors: Tags: Phys Med Biol Source Type: research
ConclusionsInstitution of a BP biological dose constraint may reduce brachial plexopathy risk without compromising target coverage. MCBD plan evaluation provides valuable information to physicians which may assist in making clinical judgments regarding relative priority of target coverage vs. normal tissue sparing.
Source: Practical Radiation Oncology - Category: Cancer & Oncology Source Type: research
To investigate the role of intensity-modulated proton therapy (IMPT) for regional nodal irradiation in patients with breast carcinoma in comparison with volumetric-modulated arc therapy (VMAT).
Source: Clinical Oncology - Category: Radiology Authors: Tags: Original Article Source Type: research
CONCLUSION: If MC is more accurate than PB as reported in the literature, dosimetric and radiobiological results from the current study suggest that PB overestimates the target dose, EUD, and TCP for IMPT breast cancer treatment. The overestimation of dosimetric and radiobiological results of the target volume by PB needs to be further interpreted in terms of clinical outcome. PMID: 31343826 [PubMed - as supplied by publisher]
Source: Journal of Applied Clinical Medical Physics - Category: Physics Authors: Tags: J Appl Clin Med Phys Source Type: research
This article discusses its uses, effectiveness, and procedure.
Source: Health News from Medical News Today - Category: Consumer Health News Tags: Breast Cancer Source Type: news
CONCLUSIONS: IMPT following IBR spared underlying organs and had low rates of acute toxicity. Reconstruction complications are more common in irradiated breasts, and reconstructive outcomes appear comparable with photon literature. Hypofractionation was associated with higher reconstruction failure rates. Further investigation of optimal dose-fractionation after IBR is needed. PMID: 31185327 [PubMed - as supplied by publisher]
Source: Radiotherapy and Oncology : journal of the European Society for Therapeutic Radiology and Oncology - Category: Radiology Authors: Tags: Radiother Oncol Source Type: research
University of Cincinnati researchers plan to enroll more than 20 women with early stage breast cancer in a unique clinical trial, which will involve the most expensive medical device in the region. The trial will involve proton radiotherapy designed to zap cancer with particles that travel faster than a bolt of lightning – and with great precision.  Treatment will take place at the $120 million Cincinnati Children’s Hospital Medical Center/UC Health Proton Therapy Center in Butler Coun ty,…
Source: bizjournals.com Health Care:Physician Practices headlines - Category: American Health Authors: Source Type: news
University of Cincinnati researchers plan to enroll more than 20 women with early stage breast cancer in a unique clinical trial, which will involve the most expensive medical device in the region. The trial will involve proton radiotherapy designed to zap cancer with particles that travel faster than a bolt of lightning – and with great precision.  Treatment will take place at the $120 million Cincinnati Children’s Hospital Medical Center/UC Health Proton Therapy Center in Butler Coun ty,…
Source: bizjournals.com Health Care:Physician Practices headlines - Category: American Health Authors: Source Type: news
Current proton therapy clinical practices primarily use the pencil-beam (PB) algorithm for dose calculations, as it has been the mainstay of commercially-available proton dose calculation algorithms and offers efficient treatment planning workflow. On the other hand, PB algorithms are known to be inaccurate in heterogeneous tissue environment or when a range shifter is used. To this end, Monte Carlo (MC) algorithm have recently been introduced into proton treatment planning systems that provide much more accurate dose modeling.
Source: Physica Medica: European Journal of Medical Physics - Category: General Medicine Authors: Tags: Original paper Source Type: research
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