Legacy MEDSearch

JULY 13, 2022

Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the AccuCinch ® Ventricular Restoration System. This program is designed to ensure patients and healthcare providers have more timely access to these medical devices. Food and Drug Administration. Ancora Heart , Inc.,

Food and Drug Administration 52

Food and Drug Administration FDA Medical Recruitment 52

Pharmaceutical Technology

APRIL 13, 2023

Following the increased use of telemedicine during the Covid-19 pandemic, the potential of digital technologies in communication, data collection, and analysis has become increasingly realised by patients, healthcare systems, and clinical trial sponsors. However, there is still some use of remote patient monitoring technologies.

Food and Drug Administration 52

Food and Drug Administration Electronics Healthcare Healthcare 52

Legacy MEDSearch

MARCH 13, 2023

Food and Drug Administration (FDA) has granted an Investigational Device Exemption (IDE) to advance the company’s PATCH Clinical Study, a multi-center, single-arm, pivotal study evaluating the safety and effectiveness of the Vivasure PerQseal ® Closure Device System. and Europe.

Medical 98

Medical FDA Food and Drug Administration Recruitment 98

Legacy MEDSearch

SEPTEMBER 29, 2023

Food and Drug Administration has approved an IDE for the company’s pivotal study to support premarket approval of its HYDRAFIL® System. Dr. Kasra Amirdelfan, Director of Clinical Research at Boomerang Healthcare, Inc. ReGelTec, Inc. announced that the U.S. Vapotherm (NYSE:VAPO), and National Sleep Technologies.

FDA 52

FDA Food and Drug Administration Recruitment Medical 52

European Pharmaceutical Review

JANUARY 16, 2023

This also occupies a large resource, given the US Food and Drug Administration (FDA) requirement for double plate checking using a second ‘independent’ person. The US federal drug GMP regulations that first became official in 1977 and their European counterparts will need to be re-interpreted for this new generation of products.

Pharmaceutical 126

Pharmaceutical Food and Drug Administration Manufacturing FDA 126

Legacy MEDSearch

FEBRUARY 3, 2023

Food and Drug Administration (FDA) has granted the first marketing clearance for its SCINTIX biology-guided radiotherapy, a cutting-edge treatment applicable for early and late-stage cancers. RefleXion Medical , a therapeutic oncology company, announced the U.S.

FDA 97

FDA Food and Drug Administration Recruitment Medical 97

Impetus Digital

NOVEMBER 14, 2022

We know from real-world evidence that drug efficacy and safety can differ based on age, sex, race, and ethnicity; these discrepancies may jeopardize treatment outcomes in undertested groups. Many clinical trials are struggling to recruit diverse participants, particularly from rural or remote areas far from large academic hospitals.

Pharma 90

Pharma Recruitment Food and Drug Administration Patients 90

Clarify Health

NOVEMBER 9, 2022

However, some communities have historically been underrepresented in clinical research due to barriers like a lack of access, awareness, and trust in drug development processes. Community leaders, such as educators, faith-based leaders, health workers, and healthcare providers, can be crucial to delivering the health information people need.

Pharma 40

Pharma Food and Drug Administration Medicine Patients 40

Clarify Health

NOVEMBER 9, 2022

However, some communities have historically been underrepresented in clinical research due to barriers like a lack of access, awareness, and trust in drug development processes. Community leaders, such as educators, faith-based leaders, health workers, and healthcare providers, can be crucial to delivering the health information people need.

Pharma 40

Pharma Food and Drug Administration Patients Medicine 40