November 11, 2024) - CardioComm Solutions, (TSXV: EKG) a global leader in medical electrocardiogram (ECG) monitoring technology and a pioneer in Remote Patient Monitoring (RPM) solutions ... is HIPAA ...

The approval was based on excellent results demonstrated in the pivotal SPHERE Per-AF study, an FDA Investigational Device Exemption (IDE) trial, which compared the Sphere-9 catheter with the Affera ...

The FDA has approved Pfizer’s marstacimab (Hympavzi) for patients with haemophilia A without factor VIII inhibitors or haemophilia B without factor IX inhibitors. Marstacimab is the first anti ...

ABU DHABI, UAE — A device characterized by the US Food and Drug Administration as safe for the treatment of dysphagia following acute stroke is finally being tested for efficacy in a randomized ...

The panel agreed to remove the 16-day reporting requirement for the RPM device supply code, which has been a sore spot for the industry over the last several years. There are several remote ...

Questioning the policy allowing the import of refurbished and pre-owned medical devices into the country ... and the Health Ministry to withdraw this approval. The group said that the policy ...

The UK's drugs regulator—the MHRA—has approved the Alzheimer's drug donanemab, but it won't be available on the NHS. The National Institute for Health and Care Excellence (Nice), which ...

This month, the Food and Drug Administration approved Iterum Therapeutics’ Orlynvah for certain kinds of urinary tract infections that aren’t likely to respond to other drugs. UTIs are some of ...

According to Nova One Advisor, the global Subcutaneous Drug Delivery Devices market size is calculated at 24.00 billion in 2024 and is projected to surpass USD 47.88 billion by 2033 with a remarkable ...

Rahul Sidhu does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond ...

Pfizer Inc. has won regulatory approval for its hympavzi drug as a treatment for hemophilia A or B without inhibitors — making it the first antitissue-factor pathway inhibitor to be allowed for ...

“Novo Nordisk’s aim with this nomination is to ensure that patients receive only FDA-approved, safe, and effective semaglutide products,” the company said in an emailed statement. Novo’s ...