MHLW

Weight-loss Programs Level Up With Smart Wearable Devices

Retrieved on: 
Friday, September 15, 2023
Sequence, CGM, Weight, Insurance, Planet Fitness, Diabetes, Garmin, Classification, Marketing, Obesity, Acquisition, Patient, Digital, Arrhythmia, News, NYSE, Financial News, Male, AMOLED, GRMN, Diet, Cael Sanderson, Smartphone, USD, Motivation, Apple, BMI, Mental health, Empowerment, Exercise, Human, WW International, National Health Service, Stroke, Sleep, Cancer, Pharmaceuticals and Medical Devices Agency, Mind, Zio, IRTC, Vital signs, PMDA, Blood, Heart rate, Hand, Blood pressure, White, Wrist, MHLW, Weight loss, Medication, Samsung, WW, Georgy Shonin, NMRD, Female, Mobile phone, Dietary supplement, Medical device, Birth control, Online shopping, Labour, Nemaura Medical, Health, Amazon

NEW YORK, Sept. 15, 2023 /PRNewswire/ -- The wearable technology market has evolved in recent years into a major tech segment, in large part thanks to consumer market growth which is driven by sales of smartwatches. Major companies like Apple and Samsung are heavily involved in the innovation of wearable devices, which are now capable of performing a wide range of features including cellular connectivity, health monitoring, contactless payment and more. Due to the advanced health monitoring features found in the devices, the wearable technology market is now playing an important role in the medical sector as well. In recent years, the devices have allowed healthcare providers to remotely monitor a patient's various physiological parameters. The most commonly measured data include vital signs such as heart rate, blood pressure, number of calories burned during a day, sleep quality and oxygen level in the blood. Nemaura Medical Inc. (NASDAQ: NMRD), Planet Fitness, Inc. (NYSE: PLNT), WW International, Inc. (NASDAQ: WW), Garmin Ltd. (NYSE: GRMN), iRhythm Technologies, Inc. (NASDAQ: IRTC)

Key Points: 
  • Due to the advanced health monitoring features found in the devices, the wearable technology market is now playing an important role in the medical sector as well.
  • In recent years, the devices have allowed healthcare providers to remotely monitor a patient's various physiological parameters.
  • Nemaura Medical Inc. (NASDAQ: NMRD) announced breaking news earlier this week regarding, "interim results from its metabolic health program.
  • The high medical needs designation in Japan is granted to innovative devices recognized as having high medical utility for significant diseases.

Guardant Health Receives Regulatory Approval in Japan for Guardant360® CDx as Companion Diagnostic to ENHERTU® for Treatment of Non-Small Cell Lung Cancer Patients with HER2 Mutations

Retrieved on: 
Tuesday, September 5, 2023
Biotechnology, Health, Science, Research, Oncology, MHLW, HER2, Woman, ERBB2, NSCLC, Lung cancer, GH, Lung, Helmy Eltoukhy, Patient, Daiichi Sankyo, MSI, Blood, FDA, Pembrolizumab, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, News, Food, Nivolumab, Vaccine, Pharmaceutical industry

ENHERTU is a specifically engineered HER2-directed antibody drug conjugate developed by Daiichi Sankyo.

Key Points: 
  • ENHERTU is a specifically engineered HER2-directed antibody drug conjugate developed by Daiichi Sankyo.
  • The approval for use of the test as a companion diagnostic with ENHERTU in Japan is an expansion of the approval received from the U.S. Food and Drug Administration (FDA) for the same indication in August 2022.
  • “The ministry’s approval of Guardant360 CDx as a companion diagnostic for ENHERTU is great news for patients with metastatic non-small cell lung cancer with HER2 mutations,” said Helmy Eltoukhy, Guardant Health chairman and co-CEO.
  • “Oncologists in Japan now have the first blood-based companion diagnostic to determine if their patients are eligible to receive the first HER2 directed therapy approved to treat this specific condition.

The Menarini Group Announces ELZONRIS® (Tagraxofusp) Designated as an Orphan Drug for BPDCN by Japanese Ministry of Health, Labor and Welfare

Retrieved on: 
Wednesday, August 30, 2023
MHLW, Patient, Blastic plasmacytoid dendritic cell neoplasm, Orphan, Menarini, Therapy, BPDCN, Pharmaceutical industry, Health

BPDCN is an aggressive orphan hematologic malignancy with historically poor clinical outcomes.

Key Points: 
  • BPDCN is an aggressive orphan hematologic malignancy with historically poor clinical outcomes.
  • Stemline's ELZONRIS® (tagraxofusp) is the only approved treatment for patients with BPDCN, and the first and only approved CD123-targeted therapy, in both the United States and Europe.
  • Orphan drug designation can potentially shorten the period required to obtain regulatory approval in Japan by several months, thereby enabling faster patient access.
  • In Japan, tagraxofusp is being developed by Nippon Shinyaku, which is currently conducting a Phase 1/2 clinical trial.

The Menarini Group Announces ELZONRIS® (Tagraxofusp) Designated as an Orphan Drug for BPDCN by Japanese Ministry of Health, Labor and Welfare

Retrieved on: 
Wednesday, August 30, 2023
MHLW, Patient, Blastic plasmacytoid dendritic cell neoplasm, Orphan, Menarini, Therapy, BPDCN, Pharmaceutical industry, Health

BPDCN is an aggressive orphan hematologic malignancy with historically poor clinical outcomes.

Key Points: 
  • BPDCN is an aggressive orphan hematologic malignancy with historically poor clinical outcomes.
  • Stemline's ELZONRIS® (tagraxofusp) is the only approved treatment for patients with BPDCN, and the first and only approved CD123-targeted therapy, in both the United States and Europe.
  • Orphan drug designation can potentially shorten the period required to obtain regulatory approval in Japan by several months, thereby enabling faster patient access.
  • In Japan, tagraxofusp is being developed by Nippon Shinyaku, which is currently conducting a Phase 1/2 clinical trial.

The Menarini Group Announces ELZONRIS® (Tagraxofusp) Designated as an Orphan Drug for BPDCN by Japanese Ministry of Health, Labor and Welfare

Retrieved on: 
Wednesday, August 30, 2023
Pharmaceutical, Health, Oncology, MHLW, Multimedia, Patient, Orphan, Therapy, BPDCN, Pharmaceutical industry

View the full release here: https://www.businesswire.com/news/home/20230830257431/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20230830257431/en/
    BPDCN is an aggressive orphan hematologic malignancy with historically poor clinical outcomes.
  • Stemline’s ELZONRIS® (tagraxofusp) is the only approved treatment for patients with BPDCN, and the first and only approved CD123-targeted therapy, in both the United States and Europe.
  • Orphan drug designation can potentially shorten the period required to obtain regulatory approval in Japan by several months, thereby enabling faster patient access.
  • In Japan, tagraxofusp is being developed by Nippon Shinyaku, which is currently conducting a Phase 1/2 clinical trial.

Revolutionizing Cardiac MRI Examinations: Vista.ai and HekaBio Announce Japan Partnership

Retrieved on: 
Tuesday, August 29, 2023
Heart, Partnership, LV, American Heart Association, MHLW, Workflow, Guideline, PALO, Management of heart failure, Google Images, MRI, Hospital, Standard of care, Patient, Heart failure, Diagnosis, CMR, FDA, Software, Medical device, Medical imaging, Health

Currently, Japan boasts world's highest MRI equipment per capita capable of performing cardiac MRI examinations.

Key Points: 
  • Currently, Japan boasts world's highest MRI equipment per capita capable of performing cardiac MRI examinations.
  • Vista.ai CEO Juan Santos commented, "We are excited to partner with HekaBio to bring our groundbreaking cardiac MRI technology to Japan.
  • With the highest number of MRI machines per capita in the world, Japan has an enormous potential to increase the access to cardiac MRI exams.
  • HekaBio CEO Robert E. Claar commented, "We're thrilled to partner with Vista.ai to introduce One Click™ MRI to Japan.

ExThera Medical Receives Certification for Medical Device Single Audit Program (MDSAP) and Recertification for International Organization for Standardization for Medical Devices (ISO 13485)

Retrieved on: 
Tuesday, August 15, 2023
Medical Devices, Infectious Diseases, Hospitals, Health, Oncology, Seraph, EUA, Medical device, Investigational device exemption, ANVISA, MHLW, ISO, COVID-19, NAE, MDSAP, Quality, Certification, MDD, Patient, Blood, European, HC, IDE, International Organization (journal), FDA, TGA, International Organization for Standardization, Medical device design, Pharmaceutical industry

ExThera Medical Corporation announces it has received simultaneous certification per Medical Device Single Audit Program (MDSAP) and International Organization for Standardization (ISO 13485) requirements.

Key Points: 
  • ExThera Medical Corporation announces it has received simultaneous certification per Medical Device Single Audit Program (MDSAP) and International Organization for Standardization (ISO 13485) requirements.
  • MDSAP certification confirms comprehensive achievement of regulatory audit requirements and compliance standards for medical device manufacturers looking to sell products within the United States (FDA), Canada (HC), Japan (MHLW), Australia (TGA), and Brazil (ANVISA).
  • MDSAP certification has the added benefit of potentially expediting the timetable to commercialization within these participating geographies.
  • The internationally recognized ISO 13485 certification further confirms achievement of medical device manufacturer quality standards requirements necessary for global market entry.

Promising disease modifying approach to Duchenne muscular dystrophy with Neu-REFIX® Beta 1,3-1,6 glucan* from Japan; the first such clinical report.

Retrieved on: 
Friday, August 4, 2023
Science, Research, Health, Genetics, Food, Beverage, Fitness & Nutrition, Clinical Trials, Retail, GMP, MAP, GRAS, Heart failure, Aureobasidium pullulans, IBRO Neuroscience Reports, Neu!, GCC, Safety, Pulmonary fibrosis, Clinical trial, MDX, Multisystemic smooth muscle dysfunction syndrome, Ageing, Quality of life, Multimedia, Facial muscles, Temperature, MRC, Inflammation, Multiple sclerosis, NSAA, Duchenne muscular dystrophy, Trial of the century, Psoriasis, System, Plasma, Fibrosis, DMD, COVID-19, Patient, EFSA, Mouse, Memorandum of understanding, Exon, MDA, Conference, DSM-IV codes, LGMD, Disease, Dietary supplement, Vaccine, MHLW

Duchenne Muscular Dystrophy (DMD) patients showed signs of disease progress slowing down, after oral consumption of Neu REFIX ß-glucan for 45 days along with routine medications.

Key Points: 
  • Duchenne Muscular Dystrophy (DMD) patients showed signs of disease progress slowing down, after oral consumption of Neu REFIX ß-glucan for 45 days along with routine medications.
  • View the full release here: https://www.businesswire.com/news/home/20230803923960/en/
    Duchenne Muscular Dystrophy (DMD); Progress of disease & gradual disability with aging, current therapies & Neu-REFIX Beta glucans' multipronged potentials, illustrated.
  • A rare genetic disease with approximately 5000 patients in Japan, 3000 in GCC, fewer than 50000 in USA.
  • Clinical research in Limb-Girdle Muscle Dystrophy (LGMD) , multiple sclerosis and psoriasis are underway, to evaluate Neu-REFIX’s efficacy as a universal immune modulator.

iRhythm Technologies Announces Second Quarter 2023 Financial Results

Retrieved on: 
Thursday, August 3, 2023
MHLW, Medicines and Healthcare products Regulatory Agency, Ministry of Health, Labour and Welfare, European Society of Cardiology, Medication, Pharmaceuticals and Medical Devices Agency, IRTC, Congress, EBITDA, Traction, Patient, PMDA, SAN, Growth, ESC, Payment card, Pharmaceutical industry, Video game, Health, Labour, Georgy Shonin

SAN FRANCISCO, Aug. 03, 2023 (GLOBE NEWSWIRE) -- iRhythm Technologies, Inc. (NASDAQ: IRTC), a leading digital health care company focused on creating trusted solutions that detect, predict, and prevent disease, today reported financial results for the three and six months ended June 30, 2023.

Key Points: 
  • SAN FRANCISCO, Aug. 03, 2023 (GLOBE NEWSWIRE) -- iRhythm Technologies, Inc. (NASDAQ: IRTC), a leading digital health care company focused on creating trusted solutions that detect, predict, and prevent disease, today reported financial results for the three and six months ended June 30, 2023.
  • Revenue for the second quarter of 2023 was $124.1 million, up 21.6% from $102.1 million during the same period in 2022.
  • Operating expenses for the second quarter of 2023 were $105.1 million, compared to $93.7 million for the same period in 2022.
  • Adjusted operating expenses for the second quarter of 2023 were $99.7 million, compared to $93.5 million during the same period in 2022.

Guardant Health announces reimbursement approval of Guardant360® CDx liquid biopsy test in Japan

Retrieved on: 
Wednesday, July 5, 2023
Biotechnology, Medical Devices, Health, Genetics, Oncology, DNA, Circulating tumor DNA, MHLW, CGP, Cancer, Food, Breast, Prostate, Biomarker, GH, Lung, Stomach, Colon, Helmy Eltoukhy, Patient, Neoplasm, Medical imaging

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, announced today that it has been informed it will receive national reimbursement approval from the Japanese Ministry of Health, Labor and Welfare (MHLW), effective July 24, 2023, for its Guardant360® CDx liquid biopsy test for comprehensive genomic profiling (CGP) for patients with advanced or metastatic solid tumor cancers.

Key Points: 
  • Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, announced today that it has been informed it will receive national reimbursement approval from the Japanese Ministry of Health, Labor and Welfare (MHLW), effective July 24, 2023, for its Guardant360® CDx liquid biopsy test for comprehensive genomic profiling (CGP) for patients with advanced or metastatic solid tumor cancers.
  • This announcement follows the regulatory approval of the Guardant360 CDx test by the MHLW in March 2022.
  • “The decision of the MHLW to provide reimbursement for Guardant360 CDx represents a significant milestone for the company as Japan is the first country in the Asia-Pacific region to reimburse the use of our test to support advanced cancer patients,” said Helmy Eltoukhy, co-CEO of Guardant Health.
  • With more than 350 peer-reviewed publications, the test has been trusted by more than 12,000 oncologists with over 400,000 tests ordered to date.