Medical Monitoring Articles & Analysis: Older

Antiprogestins act as Progesterone Receptor (PgR) antagonists. Novel and promising class of drugs to overcome endocrine resistance associated with ESR1 mutations. SMILE STUDY is a multi-institutional phase II clinical trial to determine the efficacy of an antiprogestin, Onapristone +fulvestrantas second line therapy for patients with HR+/HER2- metastatic breast cancer (MBC). Hypothesis: The ...

By Context Therapeutics Inc.

Broomfield, Colorado, 10/3/2022. Aktiv Pharma Group (Aktiv) today announced a procurement contract award from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Under this contract (number 75A50122C00082), awarded under the 2004 Project ...

By Aktiv Pharma Group, Inc

Broomfield Colorado 6/16/2022. Aktiv Pharma Group (Aktiv) announced today the acceptance of its novel glass-free, film-based flexible primary drug container (PDC) technology for sterile injectables named ARCH, into the US Food and Drug Administration (FDA) Emerging Technology Program (ETP). The ETP is a collaborative effort which supports the FDA’s mission to facilitate modernization in ...

By Aktiv Pharma Group, Inc

Broomfield Colorado 6/25/2022. Aktiv Pharma Group (Aktiv) announced today a grant award from the U.S. Department of Defense (DOD) Defense Health Agency (DHA) Joint Program Committee 6/Combat Casualty Care Research Program (JPC-6/CCCRP) [1] for the continued development of a tranexamic acid (TXA) autoinjector, targeting proposed indications related to prehospital treatment of severe bleeding. ...

By Aktiv Pharma Group, Inc

New prototype of Mojo Lens incorporates numerous industry-first features, including the world’s smallest and densest dynamic display, low-latency communication, and an eye-controlled user interface SARATOGA, Calif.--(March 30, 2022)--Mojo Vision, the Invisible Computing Company, today announced its most advanced prototype of Mojo Lens, the world's first true smart contact lens, including ...

By Mojo Vision Inc.

bout two years after the outbreak of COVID-19, many resources are still being used in the fight against this new virus. Nevertheless, the number of breast cancer cases in Italy are still very high: according to the report “The numbers of cancer in Italy”, published by AIRTUM and AIOM, in 2020 about 55.000 new cases were diagnosed in Italy among women (as of today, estimates for 2021 ...

By Metaltronica S.p.A.

POP Biotechnologies (POP BIO), a Buffalo, NY based biopharmaceutical startup, announces the approval of the plan for a phase 3 clinical study of EuCorVac-19, a COVID-19 vaccine candidate developed by South Korean partner EuBiologics (KOSDAQ: 206650, CEO, Dr. Baik YoungOk, Mr. Seukkeun Choi) from the Ministry of Food and Drug Safety in South Korea. EuCorVac-19, is a protein-based vaccine ...

By POP Biotechnologies, Inc. (POP BIO)

NORCROSS, Ga., Feb. 1, 2022 /PRNewswire/ -- Koning, a growing medical device startup company based outside Atlanta, had a successful conclusion to 2021. The company recently finished their first Republic crowdfunding campaign, exceeding capital targets, and raising over $2.6M in only 5 months. Koning's FDA breast screening trial is also underway with participating clinics in Daytona Beach, FL and ...

By Koning Corporation

On March 15th 2015, Tim Buckinx’ son said: “Papa, you work in digital, can’t you create a light that turns on when my brain switches off?” At ten years old, he was simply fed up with the daily impact of his refractory epilepsy. That pain became a vision, and that vision became the Belgian digital therapeutics company epihunter, aimed at enabling people with a brain ...

By Epihunter NV

DAYTONA BEACH, Fla., Nov. 1, 2021 /PRNewswire/ -- Koning begins an FDA screening trial this month for their no-compression, Isotropic, 3-dimensional breast imaging device. The company received FDA PMA approval for commercial, diagnostic use in 2017. Since then, the Koning Breast CT (KBCT) has been installed in clinics and universities in the US and globally. "This FDA screening trial is a major ...

By Koning Corporation

Last week (23-25th September) took place the workshop Atrial Signals 2021 http://www.atrial-signals.kit.edu/ at the Karlsruhe Institute of Technology (KIT), thanks to the joint collaboration of the Institute of Biomedical Engineering (IBT) and the Städtisches Klinikum Karlsruhe. Andreu Climent, CEO of Corify Care presented Acorys, our Non-invasive Electrocardiographic Imaging device of the ...

By Corify Care SL

COPENHAGEN, Denmark--(BUSINESS WIRE)--Neurescue, a medical device company developing innovative cardiovascular solutions to improve the outcomes for emergency patients, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to market the company’s NEURESCUE® device for temporary occlusion of large vessels, including patients requiring emergency ...

By Neurescue

BOSTON, Nov. 6, 2020 /PRNewswire/ -- Empatica has been selected by the U.S. Army Medical Research and Development Command (USAMRDC) to deploy a wearable and algorithm that enable the early and pre-symptomatic detection of COVID-19. The project's focus is on protecting the health of the general population by preventing outbreaks via early detection and alerting. Empatica's Aura algorithm gives a ...

By Empatica Inc.

Introduction Anliprogestins have demonstrated promising activity against breast and gynecological cancers, but liver-related safety concerns limited the advancement of this therapeutic class. Onapristone is a full progesterone receptor antagonist originally developed as an oral contraceptive and later evaluated in phase II studies for metastatic breast cancer. Because of liver enzyme elevations ...

By Context Therapeutics Inc.

BOSTON, June 19, 2020 /PRNewswire/ -- Digital healthcare company Empatica announces a pioneering new partnership with the Biomedical Advanced Research and Development Authority ("BARDA"), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS), to validate an early warning system for COVID-19 and other respiratory ...

By Empatica Inc.

As a patient facing breast cancer surgery, you should know that precise "marking" of your cancer surgical site is an important part of your treatment. A marker is a device inserted at the surgical site. Precision in marking helps make sure you retain as much normal breast tissue as possible with the surgery. This ultimately leads to best overall post-surgical care by your wellness team. A new ...

By Videra Surgical Inc.

The Journal of Asthma published the results of a study that assessed asthma patients and their ability to perform high-quality daily spirometry with the AioCare system. The study has shown that home spirometry is safe without supervision and feasible for asthma patients. Abstract: Background: Self-management is an appealing strategy for the prevention of asthma exacerbations. This study aimed ...

By AioCare

Aidar Health, formerly known as Multisensor Diagnostics, has developed a portable hand-held device that allows patients to measure and track vital signs in a matter of seconds. Roughly the size of an iPhone, MouthLab consists of a hand unit and a mouthpiece that fits between the teeth and lips. The mouthpiece uses special sensors to gather information from breathing patterns, saliva and blood ...

By Aidar Health

The American Food and Drug Administration (FDA) has granted Orphan Drug Designation to ZENEO® Midazolam for the treatment of status epilepticus (epileptic seizure lasting longer than 5 minutes). The orphan designation for ZENEO® Midazolam improves Crossject’s international visibility and gives impetus to its current negotiations for partnerships with pharmaceutical laboratories. ...

By Crossject

In April 2013, final-year Danish medical student Habib Frost was called out to an emergency: a four-month old girl had just suffered cardiac arrest. Frost’s team tried defibrillation, but to no avail. Immediately after, the team was called out again: another case of cardiac arrest, this time a woman in her 30s. Once again, Frost was powerless to save her life. “I felt ...

By Neurescue