Biorithm raises $3.5M Series A for remote maternal monitoring tech
Biorithm announced that it closed a $3.5 million Series A funding round to support its personalized, connected maternity care technology. Adaptive Capital Partners and SEEDS Capital co-led the funding round. Cambridge, Massachusetts-based Biorithm plans to use the funds to fuel... Read More →
Bone Health Technologies’ Osteoboost Cleared by FDA
The wearable device is indicated to reduce bone strength and density decline in postmenopausal women and is designed to improve bone health during osteopenia. The U.S. Food and Drug Administration (FDA) has granted clearance for Bone Health Technologies’ Osteoboost, a... Read More →
Osso virtual reality training academy adds 5 orthopedic modules
Immersive surgical training program company Osso VR has added five new orthopedic training modules to its Osso Academy, a virtual reality medical training library. Osso offers medical trainees access to one of the largest orthopedic virtual reality training libraries, with... Read More →
FDA Clearance Granted for First AI-Powered Medical Device to Detect All Three Common Skin Cancers (Melanoma, Basal Cell Carcinoma and Squamous Cell Carcinoma)
MIAMI–(BUSINESS WIRE)–DermaSensor Inc. announces FDA clearance for its real-time, non-invasive skin cancer evaluation system. For the first time, the 300,000 primary care physicians in the U.S. can now be equipped to provide quantitative, point-of-care testing for all types of skin... Read More →
Bloomlife Announces FDA Clearance of Bloomlife MFM-Pro
SAN FRANCISCO, Jan. 16, 2024 /PRNewswire/ — Bloomlife, the award winning maternal health company, has received clearance from the US Food and Drug Administration (FDA) for Bloomlife MFM-Pro, their first maternal and fetal monitoring device. This announcement comes on the... Read More →
InkSpace Imaging receives FDA Clearance for a 24-channel Small Body Array Compatible with Siemens Healthineers 3T Systems
PLEASANTON, Calif., Jan. 11, 2024 (GLOBE NEWSWIRE) — InkSpace Imaging, a leader in innovative diagnostic medical device technology, is proud to announce it received FDA clearance for its next-generation Small Body Array for the Siemens Healthineers Magnetom Skyra and Vida... Read More →
FDA grants first clearance to AI program for diagnosing idiopathic pulmonary fibrosis
The artificial intelligence developer Imvaria has claimed a de novo clearance from the FDA for a digital diagnostic that analyzes chest CT scans for the signs of idiopathic pulmonary fibrosis. According to the Berkeley, California-based startup, the green light for... Read More →
Sonavex Announces Successful Clinical Study of EchoMark & EchoSure and Initiation of the MAFASA Randomized Controlled Trial
FDA IDE approval of Sonavex’s randomized trial comes months after meeting the endpoint of its first clinical study Baltimore, MD (January 2nd, 2024) – Sonavex, Inc., a privately held medical device company with ultrasound technologies that deliver quantitative blood flow... Read More →
Darmiyan Receives FDA Approval for BrainSee, the First Prognostic Test for Predicting Likelihood of Progression to Alzheimer’s Dementia
FDA’s De Novo approval of BrainSee represents a major advancement in Alzheimer’s diagnostics. Utilizing cutting-edge image processing and medical AI, BrainSee establishes a new standard for predicting progression from amnestic mild cognitive impairment (aMCI) to Alzheimer’s dementia. This breakthrough is... Read More →
Distalmotion, Proximie partner for robotic surgery platform extension
The partnership leverages Distalmotion’s Dexter robotic surgery for improved patient care and global surgical collaboration. istalmotion has announced a partnership with Proximie, a health technology platform, to globally extend the capabilities of its Dexter robotic surgery system. The collaboration will... Read More →