Tag Archives: FDA

Recently, the Coalition for Health AI (CHAI), a prominent industry group aiming to create standards for the utilization of artificial intelligence (AI) in healthcare, witnessed the resignations of two key federal government officials from its board of directors. Micky Tripathi, the national coordinator for health information technology, and Troy Tazbaz, director of the digital health […]

Continue Reading

At the recent Galaxy Unpacked event in Paris, Samsung introduced a series of new AI-powered devices aimed at enhancing health and wellness through advanced technology. Among the new offerings are the Galaxy Ring, the Galaxy Watch Ultra, and the updated Galaxy Watch 7. The standout debut was the Galaxy Ring, Samsung’s first foray into health-monitoring […]

Continue Reading

Philips has initiated a recall for several models of its Sense XL Torso coils utilized in MRI machines due to the potential for these devices to overheat, posing a risk of burns to patients during MRI scans. The recall impacts six models of the Sense XL Torso coils that are compatible with both 1.5T and […]

Continue Reading

Pulse Biosciences has announced a significant shift in its regulatory strategy for the Cellfx cardiac clamp, a pulsed field ablation (PFA) device initially being guided through the 510(k) pathway for clearance. The company initially filed for 510(k) clearance in January, but after the Food and Drug Administration (FDA) requested human data, Pulse has now decided […]

Continue Reading

In the growing field of healthcare technology, artificial intelligence (AI) is increasingly being integrated into solutions aimed at enhancing the clinical experience. While some applications of AI in healthcare, like ambient AI scribes, are widely accepted for reducing administrative duties and increasing clinician-patient interaction time, many AI iterations fall into a less controlled area likened […]

Continue Reading

In the world of medical device manufacturing, the primary goal is to deliver safe, effective, and pertinent solutions to healthcare problems. A recurring challenge, however, arises when a device meets its specified requirements but fails to address the actual needs of its intended users. This disconnect emphasizes the critical need for accurately defining user needs […]

Continue Reading

Eli Lilly, a major player in the pharmaceutical industry, is taking strides toward offering more convenient treatment options for patients with inflammatory diseases through the development of pill-based therapies. The company’s latest move in this direction is the $3.2 billion acquisition of Morphic Therapeutic, a deal that adds a promising oral small molecule drug candidate […]

Continue Reading

The European Medicines Agency (EMA) has recently approved Dupixent, a drug developed by Sanofi and Regeneron Pharmaceuticals, as the first biologic therapy for adults with uncontrolled chronic obstructive pulmonary disorder (COPD) characterized by elevated blood levels of eosinophils, a type of white blood cell. This marks a significant development in the treatment for COPD, particularly […]

Continue Reading

Immunology and inflammation biotechnology company Alumis has recently entered the public markets, securing $250 million in pivotal funding to advance clinical trials of its leading drug candidate. The company aims to demonstrate the efficacy of its small molecule in treating plaque psoriasis, a competitive area currently targeted by several pharmaceutical giants. Alumis’ entry into Nasdaq […]

Continue Reading

AbbVie, a major pharmaceutical company already noted for its leadership in the inflammatory bowel disease (IBD) market with several blockbuster drugs, is further expanding its IBD offerings through strategic acquisitions and development of new drug candidates. Recently, AbbVie has reinforced its commitment to advancing IBD treatment by completing the acquisition of Celsius Therapeutics for $250 […]

Continue Reading