The latest global regulatory news, changes and updates affecting medical devices and technologies, including: New test beats biopsy for transplant rejection; NICE eyes digital health HTAs; MHRA moves on the hazards of bedrails; TGA zeroes in on tests for COVID-19; HHS posts rule for agency enforcement action.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Excalibur Healthcare Services, Siemens Healthineers, Vestibular First.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acarix, Exact Sciences, Glaukos, Nexstim, Lumiradx.
LONDON – The U.K. has launched a nationwide free testing program to diagnose COVID-19 in people who are asymptomatic, in the latest attempt to stem the tide of infection. Through the program, all local authorities will provide rapid testing using lateral flow devices. In addition, companies will be provided with free tests to set up workplace screening. Initially, the focus of both strands will be on getting people who cannot work from home to come forward for regular checks.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biomerica, Cognito Therapeutics, Cytosorbents, Jud Care, Medskin Solutions Dr. Suwelack, Microvention, Ortho, Quanterix, Therapixel.
With uncertainty continuing to surround the ongoing pandemic, Biointellisense Inc. has revealed that it is teaming up with the American College of Cardiology (ACC) to advance remote patient monitoring programs for cardiac care. In addition, the ACC plans to offer the company's Biobutton COVID-19 Screening Solution at the 70th Annual Scientific Session & Expo, scheduled for May 15-17 in Atlanta.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: GAO shoots down Draeger appeal of VA bid; Three EU nations join stockpile program.
Keeping you up to date on recent developments in cardiology, including: MRI shows lower degrees of myocarditis in athletes who have recovered from COVID-19; Nanodroplets, ultrasound drills show promise with blood clots; Common blood pressure meds safe for those with COVID-19.
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