Recognizing that academic sponsors and nonprofits are major contributors to the development of advanced therapy medical products (ATMPs) and diagnostic and delivery devices, the EMA is launching a pilot program to help them navigate the challenging regulatory requirements in the space.
A new technique may allow reduction of intraocular pressure (IOP) associated with glaucoma without opening the anterior eye chamber, eliminating much of the risk associated with current glaucoma procedures. The cilio-scleral inter-position device (CID) facilitates outflow without creating an artificial egress using a thin one-piece implant.
The European Commission (EC) is proposing a novel cancer screening program that would improve cancer outcomes by fostering more frequent cancer screenings among European Union (EU) member nations. The primary focus is on screening for breast, cervical and colorectal cancers, but the plan carries a lofty target of providing screening services for 90% of those who qualify for screening.
Volta Medical SAS reported validation for its VX1 software mapping system, an artificial intelligence (AI) algorithm compatible with most commonly available multi-pole catheters and technology used in operating rooms and cath labs for treating cardiac arrhythmia. Results from the proof-of-concept-study were published in the Journal of Cardiovascular Electrophysiology.
EU health ministers have warned that developers of medical devices face trouble ahead in meeting deadlines for implementing the two new key regulations for medical devices (MDR) and in vitro diagnostics (IVDR). These were planned to enter into force in May 2021 and May 2022 respectively. EU executives and stakeholders have now all accepted that delays in complying with the regulations could result in issues achieving certification for medical devices, threatening shortages in the market.
Despite wide availability and coverage for colonoscopy, many patients diagnosed with colorectal cancer (CRC) have never undergone the recommended screening procedure for the malignancy and its precursors. As a result, the cancer has already spread in the majority of cases at the time of diagnosis. CRC remains the third most common cancer diagnosed in the U.S. and the second leading cause of cancer death for both men and women.
The association of health care professionals in Normandy (APRIC) and the regional support group for the development of e-health in Normandy released new data on the importance of home telemonitoring in heart failure. Patients participating in the Suivi Clinique à Domicile (SCAD) heart failure home telemonitoring program experience less re-hospitalizations and lower death rates than patients with the same pathology but not on the program.
Angioplasty and stenting have combined to become the standard of care for patients with myocardia that sustained damage due to an infarct, but a new study suggests that some of these patients are no worse off with medical management compared to a trip to the cath lab.
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