All articles by Amit Thadani
Amit Thadani
Ark Surgical Receives FDA Clearance for the LapBox Tissue Containment Removal System for Manual Morcellation
Designed for the safe and simple removal of tissue, the LapBox empowers gynecologists to use manual morcellation during minimally invasive laparoscopic procedures as an alternative to higher-risk open surgery.
The UAE reaffirms its position as a global healthcare hub following AED2.8 billion deals secured at Arab Health 2022
Dubai, United Arab Emirates, 14 September 2022: Arab Health has underscored its position as the epicentre of healthcare trade and reaffirmed its support for global businesses and governments by securing AED2.8 billion worth of healthcare industry-related contracts according to a GRS Explori Exhibitor Survey during the 2022 edition, which was held in Dubai in January.
IceCure Submits Regulatory Filing in Vietnam for Approval of ProSense®
Company is rapidly expanding its global regulatory and commercial reach
Ibex Reports Excellent Outcomes for AI-supported Diagnosis of Breast Cancer
Pathologists who used Ibex’s Galen™ Breast for cancer diagnosis obtained very high accuracy In a multi-site clinical study
Devyser’s quality management system and fetal diagnostics product approved under the new European IVD Regulation
STOCKHOLM — Devyser has today been certified under the new, more comprehensive IVD Regulation that came into force on May 26, 2022. The certification, issued by the notified body TÜV SÜD, covers Devyser’s quality management system and fetal diagnostics product. The approval strengthens Devyser’s position in the market and confirms the company’s long-term focus on quality and patient safety.
Cue Health Makes De Novo Submission to FDA for Full Clearance of its Cue® Flu Molecular Test
SAN DIEGO — Cue Health (“Cue”) ( Nasdaq: HLTH) today announced that it has made a de novo submission to the U.S. Food and Drug Administration (FDA) for full clearance of the Cue® Flu Molecular Test for at-home and point-of-care (POC) use. There are currently no flu tests on the market for home use. FDA clearance of Cue’s test would provide the public, for the first time, an at-home and POC molecular flu test that has been fully reviewed by the FDA for safety and effectiveness.
BD acquires MedKeeper to offer cloud-based pharmacy management solutions
The acquisition will complement BD’s technology pharmacy solutions and further advance its smart, customisable, connected care platform to optimise IV workflow
EC to extend Bavarian Nordic’s Imvanex indication to prevent monkeypox disease
Based on the CHMP recommendation, the European Commission (EC) will grant the final approval soon, which will be valid in all the Member States of the European Union (EU) along with Iceland, Liechtenstein, and Norway
Amazon to acquire primary care provider One Medical for $3.9bn
One Medical provides in-person care, along with digital health and virtual care services, allowing patients to schedule appointments, renew prescriptions, access health records
Bavarian Nordic to supply additional monkeypox shots to US, Europe
Jynneos is a liquid-frozen non-replicating smallpox vaccine that has been approved by the US Food and Drug Administration (FDA) as the only vaccine against monkeypox