Sensydia Corp. reeled in $8 million in a financing round to advance its noninvasive Cardiac Performance System (CPS) platform, which uses heart sound analysis to enable earlier detection and better therapy guidance for patients suffering from heart failure and pulmonary hypertension. The funds will be used to finalize product development, acquire tooling, begin manufacturing and make submissions to the U.S. FDA.
A new urine test from Convergent Genomics Inc. correctly predicts bladder cancer as early as 12 years before clinical symptoms occur, new data presented at the 2023 American Urological Association annual meeting shows. The Uroamp test, which can be administered at home and in point-of-care settings, could increase survival rates and help to reduce health care costs.
The FDA gave the greenlight to Route 92 Medical Inc. for its Freeclimb 70 reperfusion system in the treatment of ischemic stroke. The 510(k) clearance includes a Freeclimb 70 aspiration catheter, as well as a Tenzing 7 delivery catheter.
Pattern Bioscience Inc. reeled in $28.7 million in a series C financing led by Illumina Ventures and Omnimed Capital. The money will be used to complete development of its rapid phenotypic test platform for infectious diseases, conduct clinical validation studies and submit the platform and Pattern’s initial test, for pneumonia, for U.S. FDA review.
Cardiex Ltd. won U.S. FDA clearance for its Conneqt Pulse vascular biometric monitor. According to the digital health and wearables company, the device is the first in the world to provide measurements of both brachial blood pressure in the arm and central blood pressure in the heart and aorta, as well as arterial waveform analysis and other clinically relevant vascular biomarkers, outside the hospital, research institutions or clinical trial sites.
Rapidai Inc. received FDA 510(k) clearance for its Rapid NCCT Stroke technology, the latest tool in its portfolio of non-contrast-based solutions for shock and trauma care. The company claims it is the first and only medical device cleared by the agency to detect suspected intracranial hemorrhage (ICH) and large vessel occlusion (LVO) from value-based CT imaging.
Liquid biopsy company Epic Sciences Inc. reeled in $24 million in a series G financing co-led by Deerfield Management and Arsenal Capital Partners. The funds will be used to build the commercial infrastructure needed successfully market DefineMBC, its comprehensive blood-based test for patients with metastatic breast cancer.
The U.S. FDA has granted de novo authorization to Moximed Inc. for its Misha knee system, a first-of-its-kind implantable shock absorber for people suffering from osteoarthritis (OA) of the knee. The device is intended to relieve pain and improve daily function in patients ineligible for, or not ready to undergo, joint replacement.
Positive results from Limflow SA’s PROMISE II U.S. pivotal trial show its Limflow system for transcatheter arterialization of deep veins (TADV) led to sustained amputation-free survival and wound healing in patients with chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease. According to the Paris-based company, 76% of CLTI patients who received Limflow therapy were able to avoid an otherwise life-saving major amputation.
