GT Medical Technologies Inc. revealed that it has raised $16 million in a series B financing round led by MVM Partners, which was joined by existing investors Medtech Venture Partners and Bluestone Venture Partners. Funds will support the expanded commercialization of Gammatile Therapy, a surgically targeted radiation therapy (STaRT) that is intended to help patients with brain tumors. Read More
The U.S. FDA cleared Alivecor Inc.'s Kardia AI V2 interpretive electrocardiogram (ECG) algorithm for use in its personal ECG app and devices. Currently, the Kardia line permits consumers to take a 30-second medical grade ECG at home and instantly see whether they are exhibiting symptoms of atrial fibrillation, bradycardia, tachycardia or have normal heart rhythm. Read More
Two U.S. federal agencies at the Department of Health and Human Services (HHS) have finalized rules that affect how drug and device makers interact with the health care system, but under the Congressional Review Act, neither rule can go into effect until February 2021. This timeline comes up a couple of weeks after President-elect Joseph Biden is sworn in, thus raising the risk that the new administration at HHS will either modify or overturn these rules altogether. Read More
Hologic Inc. has gained approval from the U.S. FDA to add a diagnostic claim to its HIV type 1 viral load monitoring assay. This makes the Aptima HIV-1 Quant Dx assay the first dual-claim assay in the U.S., allowing both viral load monitoring and diagnosis. For laboratories that use the assay, the dual claim allows for consolidated testing on one automated platform, adding to efficiency. Read More
PARIS – Ganymed Robotics SAS reported the successful completion of functional prototype testing for its surgical robotic assistant used in total knee arthroplasty. According to a systematic review of the literature, published in the Journal of Arthroplasty, more than 2 million patients undergo knee arthroplasty each year after suffering arthritis of the knee. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alivecor, Alr Technologies, Baxter, Tandem Diabetes Care. Read More
Keeping you up to date on recent developments in cardiology, including: 3D-printed heart models aim to train future surgeons; Researchers: Digital program lowered patients’ cholesterol, blood pressure; Additional monitoring may be needed for those at risk of atrial fibrillation. Read More
